Oracle Argus Safety

User's Guide

Release 8.4.3
F96076-01
May 2024
Oracle Argus Safety User's Guide, Release 8.4.3

F96076-01

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Contents
Preface
Documentation accessibility xv
Diversity and Inclusion xv
Related resources xv
Access to Oracle Support xv

1 Know your basics

Product overview 1-1
Log in 1-1
Change your password 1-2
Begin on the Personal Argus Status page 1-3
Use the Quick Launch Toolbar 1-3
Use field validations 1-4
Acceptable date formats 1-5
Use other (than English) language text 1-5
Text translation 1-6
Enter reasons for missing (Null Flavor) data 1-8
Dynamic workflow indicator 1-8
Case form user preferences 1-9
Scale and Layout 1-9
Integrate with Oracle Argus Insight 1-9
Sharing a case series in Oracle Argus Safety with Oracle Argus Insight 1-10
Sharing a case series in Oracle Argus Insight with Oracle Argus Safety 1-10
ETL status for enterprise products 1-10
Log out 1-12
FAQs 1-12
What happens if I enter a wrong password? 1-13
Why can't I change my password? 1-13
How do I get help? 1-14
How do I view contents of the generated PDF when it contains uncommon or
unsupported characters? 1-14
How do I trigger autocalculation? 1-14

iii
 How do I generate batch reports? 1-14

2 Enter case data

Create a new case 2-1
Enter a new case 2-1
Initial case entry—fields descriptions 2-3
Check for duplicates 2-4
Receipt range—fields descriptions 2-4
Smart duplicate search 2-5
Initial case entry—BookIn dialog box 2-9
Accept incoming cases 2-9
View pending case 2-10
View rejected cases 2-10
Enter general information 2-10
General information—field descriptions 2-11
Enter study information 2-12
Study information—field descriptions 2-12
Enter reporter information 2-13
Add reporter information 2-13
Reporter information—field descriptions 2-14
Enter literature information 2-15
Enter patient information 2-15
Enter current medical status 2-15
Copy patient information from reporter information 2-15
Patient information—field descriptions 2-16
Enter patient notes 2-17
Enter patient details 2-17
Enter pregnancy information 2-18
Enter patient death details 2-18
Event death details—field descriptions 2-18
Enter other relevant history 2-19
Other relevant history—field descriptions 2-19
Enter lab data—lab test and test results 2-21
Lab data—field descriptions 2-21
Enter additional test information 2-22
Enter parent information 2-22
Enter product information 2-22
Search for products 2-23
Product Browser based search 2-23
WHO Drug Browser based search 2-23
Enter time measurement information 2-24

iv
 Enter drug information 2-25
Product information—field descriptions 2-25
Enter product indications on the drug tab 2-30
Enter Quality Control information 2-31
Enter dosage regimens 2-32
Enter product details 2-33
Enter study drug information 2-34
Enter device information 2-35
Enter product information 2-35
Enter Quality Control information on the Device tab 2-38
Enter product indications 2-38
Select product delivered by device 2-38
Enter device component information 2-38
Device information—field descriptions 2-38
Enter vaccine information 2-41
Enter product details 2-41
Enter prior adverse events information 2-41
Enter product information 2-41
Complete vaccine administration form 2-42
Enter vaccine history 2-43
Enter event information 2-43
Events tab—field descriptions 2-44
Enter data on the Event Information tab 2-44
Event information—field descriptions 2-45
Review a diagnosis-event relationship 2-46
Associate a symptom with the diagnosis 2-46
Auto-populate event information 2-47
Configure regulatory reporting rules 2-47
Enter event coding information 2-47
Enter seriousness criteria 2-48
Enter death details 2-48
Enter hospitalization details 2-48
Select nature of event 2-49
Enter event notes 2-49
Enter event assessment information 2-49
Event assessment tab—user actions 2-52
Filter event assessment details 2-53
Enter product-event details 2-54
Add attachments to your case 2-54
Enter additional information for the attachments 2-55
Sort attachments 2-57
Search for Documentum links 2-57

v
 Attach files to a case 2-57
Enter keywords 2-58
Attach references to a case 2-58
View and print attachments 2-58
Review local labeling 2-58
Enable local data entry for Japan 2-59
Enable local data entry 2-59
About local fields 2-60
Access local case data lock functionality 2-61
Process an outlier 2-62
Activate local locking in Oracle Argus Safety 2-63
Enter local reports configuration seed data 2-63
Enter local users seed data 2-64
Enter local fields seed data 2-64

3 Process case data

Access cases 3-1
Search for a case 3-1
Search for a case assigned to you 3-2
Process cases 3-2
View assigned and unassigned cases 3-2
View the case workload for one or more individuals or sites 3-3
View the workflow status for cases 3-3
Route a case to another workflow state 3-4
Route multiple cases to another workflow state 3-5
Add a follow-up event to a case 3-6
Unblind cases to a study 3-6
Copy a case 3-7
Lock or unlock a case 3-8
Delete a case 3-8
Undelete a case 3-9
Formally close a case 3-9
Print case details for a case 3-10
Print letters and attachments for a case 3-10
Review cases 3-11
View correspondence contacts for a case 3-11
Generate a letter on a case 3-11
Track correspondence for a case 3-12
View case action items 3-12
View revisions for a case 3-13
View the audit log for a case 3-13

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 View the coding status of a case 3-14
Perform a medical review of a case 3-14
Perform a coding review of a case 3-15
Perform a regulatory submission review of a case 3-15
FAQs 3-17
What is a case owner? 3-18
Can I reassign a case to another owner? 3-18
When does a case become open? 3-18
How do I create a query-type action item for a case? 3-18
What happens to a query-type action item after its due date has passed? 3-18
How can I view a summary of all the open cases? 3-19
How can I view a summary of cases with open action items? 3-19
When can I formally close a case? 3-19
What happens to a study if I unblind the cases that are associated with it? 3-19
How can I track which case revision contains significant follow-up information for the
case? 3-19
How can I interpret the differences between two narratives for a case? 3-19
What other case details can I retrieve from the Routing Comments log? 3-20
Can I view the original case from a copied case? 3-20
What are the lock states for a case? 3-20
Can I apply a local lock on a case that already has a local lock for another country? 3-20
If I am an Oracle Argus Safety Japan user, can I enter local data, copy or modify a case
that has a global lock? 3-20
If I am an Oracle Argus Safety Japan user, can I apply both a local and a global lock on
a Local PRPT case that I entered? 3-21
Can I change the outcome of a case as part of my medical review for the case? 3-21
Can I change the causality for a case during my medical review? 3-21
What do the case assessment values stand for? 3-21
Who is the MDR contact person? 3-22
How does Oracle Argus Safety set the Receipt Date for a case? 3-22
How does Oracle Argus Safety set the Aware Date for a case? 3-22
How does Oracle Argus Safety set the Date Received value for a case? 3-22
Which actions can I perform on a saved letter? 3-22
Can I edit or remove a letter after it was sent for a case? 3-22
If I change the Date Sent value for a letter, must I also change the Due Date for the
action item associated with the letter? 3-22
Where can I view action items for letters? 3-23
Why do only some action items for a case appear as Sent in Letter? 3-23
Can I auto-generate a letter for a case? 3-23
Which actions can I do on an auto-generated letter? 3-23
What does the coding status icon indicate for a case? 3-23
Why does a border appear for a coding action item for a case? 3-23
Why is there a green dot in the Notes area of a case summary? 3-24

vii
 Why do only some user names appear in bold in the Case Workload? 3-24
Why does the () icon appear as the lock state icon for a case? 3-24
Why do some letter icons from the Contact Log have an exclamation mark? 3-24
Why does an asterisk (*) symbol appear next to the username for some users in the
Case Routing dialog? 3-24
How to attach multiple files to a single letter for follow ups? 3-24
What if 3-24
The Medical Review page appears empty for a Case Form 3-25
The narrative text for a case contains blank spaces or placeholders 3-25
I can't change the assessed seriousness of a case 3-25
I can't change the determined listedness of a case 3-25
I can't select the language I need for my text narrative? 3-25

4 Filter cases with advanced conditions

Create a single filter 4-1
Create a set of related filters 4-2
Share filters with other users 4-2
Modify a filter 4-3
Use filters to view the case series list 4-3
Export the case series list to a spreadsheet 4-3
Import a case series list from the spreadsheet and save 4-4
Find filters 4-5
Access filters from the Advanced Condition Library 4-5
FAQs 4-6
What is an advanced condition? 4-6
What is an advanced condition query set? 4-6
How do the logical operators work? 4-6
How do the set operators work? 4-6
What is a case series (formerly Hit list)? 4-6
What if 4-7
I am unable to find a filter 4-7
I am unable to view cases that match the filter criteria 4-7
I am unable to view values of a codelist 4-7
While adding a value to a property, the Select button is disabled 4-7

5 Code an adverse event term

Autocode a term 5-1
Manually code a term 5-1
FAQs 5-2
Which dictionaries does Argus Safety support? 5-2

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 What is the MedDRA browser? 5-2
What are the five levels of the MedDRA dictionary? 5-2
What is a synonym? 5-3
What is autocoding? 5-3
What happens if you don't enable autocoding? 5-3
What are Standard MedDRA Queries (SMQs)? 5-3
What is a full search? 5-3
What is a non-current term? 5-3
How can I view details for a coded term? 5-4
How can I narrow my search in the MedDRA browser? 5-4
Why does a dictionary coding appear highlighted in yellow in the MedDRA browser? 5-4
Why can't I use the Export button to export a coding? 5-4
What is Null Flavor data? 5-4
What if 5-4
Autocoding is not enabled in my application 5-5
Autocoding is unsuccessful 5-5
I receive a "No Records Found" message when I manually code a term 5-5
The coding I previously used for a term now features an asterisk and can no longer be
selected in the MedDRA browser, as it is labeled as non-current 5-5

6 Manage your Expedited Report submissions

Schedule an Expedited Report 6-1
Schedule a report manually 6-1
Auto-schedule a report 6-2
Create unscheduled Expedited Reports or batch print reports 6-2
Review a draft Expedited Report 6-3
Review your scheduled reports 6-4
Review a list of your scheduled reports 6-4
View your scheduled reports 6-5
View Expedited Report status 6-6
Submit your Expedited Reports 6-6
Generate an Expedited Report 6-7
Approve your report 6-7
Transmit an ICSR 6-8
Transmit several ICSRs at once 6-8
Filter reports 6-8
User options 6-9
View routing details 6-9
Print your reports 6-9
Bulk print user options 6-10
Store Expedited Reports in Documentum 6-10

ix
Track your Expedited Report submissions 6-10
Track ICSR outgoing status 6-10
View ICSR transmit status 6-10
Search for reports 6-11
Search for ESM messages 6-12
View search results 6-12
ICSR Pending screen icons 6-13
Track your failed ICSR imports 6-15
Manage your Incoming ICSRs 6-16
Track incoming ICSR reports 6-16
Button and right-click options 6-17
Track bulk incoming ICSR reports 6-18
Search for duplicate reports 6-18
View duplicate search options and actions 6-19
Search duplicates for incoming review 6-20
View differences report 6-21
Accept initial E2B cases as follow-up 6-22
View processed ICSR reports 6-22
Search for reports 6-22
View search results 6-22
Track ICSR incoming status 6-23
Find overdue reports 6-23
FAQs 6-23
What is a scheduled report? 6-24
What is a generated report? 6-24
What happens when a report is approved? 6-24
What is the difference between submitting and transmitting a report? 6-24
What happens when manually scheduling a Local Japan report? 6-24
What happens when auto-scheduling a Local Japan report? 6-25
What components are affected by the expedited reporting rules algorithm? 6-26
Suppression of duplicate reports 6-26
Blinded or forced distribution 6-26
When are follow-up reports created? 6-27
When are the amendments created? 6-28
Why can't I view a draft report? 6-28
Why doesn't my draft report print a follow-up number? 6-28
How does the Lock State Column under Reports > Compliance > Expedited allow me to
sort my cases? 6-29
How do I view the status of my Expedited Report? 6-30
How do I know if an unscheduled report is due soon or needs to be submitted? 6-30
Where can I view single reports which have been generated as part of a periodic report? 6-30

x
7 Manage your periodic report submissions
Prepare content for periodic reports 7-1
Prepare your aggregate reports 7-1
Understand aggregate reports 7-1
View saved aggregate reports 7-2
Create a Case Data Analysis report 7-3
Create a CIOMS II Line Listing report 7-4
Create a case listing report 7-4
Check aggregate report execution status 7-5
Periodic report types 7-5
Store periodic reports in Documentum 7-6
View a summary of periodic regulatory reports 7-6
Use the library page 7-6
Prepare content for a Clinical Trial Periodic Report 7-6
Create a Clinical Trial Periodic Report 7-7
Enter common fields information 7-7
Configure subject in the report header 7-8
Select products to include in CTPR 7-9
Configure license or study in the report header 7-9
Select inclusion criteria 7-10
Use the Data Lock Point (DLP) version 7-12
Use DLP queries for dates 7-12
Use As of Reporting function 7-12
Find DLP and As of Query functionality 7-12
Include line listing 7-13
Add data elements 7-13
View selected data elements 7-13
Group cases 7-14
Specify summary tabulations for line listing 7-14
Generate single case submission report 7-18
Select summary listing 7-18
Schedule the report 7-19
Setup frequency of the scheduled reports 7-19
Configure security level of the report 7-19
Use report templates 7-20
Prepare content for an ICH PSUR 7-20
Create Periodic Safety Update Reports (PSURs) 7-21
Enter common fields information 7-21
Configure subject in the report header 7-21
Select products to include in ICH PSUR 7-22
Select inclusion criteria 7-22

xi
 Include line listing 7-24
Add data elements 7-24
View selected data elements 7-24
Group cases 7-25
Specify summary tabulations for line listing 7-25
Include CIOMS reports 7-26
Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical
trials 7-26
Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-
Marketing Data Sources 7-27
Add cumulative summary 7-28
Add FDA PSUR support information 7-28
Generate single case submission report 7-29
Select summary listing 7-30
Schedule the report 7-30
Setup frequency of the scheduled reports 7-30
Configure security level of the report 7-30
Use report templates 7-30
Prepare content for a US IND periodic report 7-31
Create new IND report 7-31
Enter common fields information 7-31
Configure subject in the report header 7-31
Select products to generate the report 7-32
Select inclusion criteria 7-33
Include line listing 7-33
Specify summary tabulations for line listing 7-34
Schedule the report 7-34
Configure security level of the report 7-34
Prepare content for an NDA periodic report 7-35
Create NDA summary report 7-36
Enter common fields information 7-36
Configure subject in the report header 7-36
Select products to generate the report 7-37
Select inclusion criteria 7-38
Include line listing 7-38
Specify summary tabulations for line listing 7-40
Schedule the report 7-41
Configure security level of the report 7-41
View scheduled periodic report information 7-41
Available user options 7-41
View report details 7-41
View report schedule details 7-42

xii
 View report routing history 7-42
Submit a periodic report 7-42
Specify submission details 7-42
Add comments 7-42
Transmit a report 7-43
View report generation status 7-43
Create unscheduled periodic reports 7-45
Approve and submit a report 7-45
View submitted reports 7-46
Use bulk report 7-46
Filter bulk reports 7-47
View bulk report filter results 7-47
Print reports in bulk 7-49
Sort cases 7-49
Lock state icon options 7-49
Track your periodic report submission 7-50
Use submitted reports search results 7-50
Reopen submitted reports 7-50
About initial and follow-up cases in periodic reports 7-51
View batch reports scheduled for generation 7-51

8 Work in a multi-tenant Oracle Argus environment

Access your global worklist items 8-1
FAQs 8-2
What is a tenant? 8-2
What is multi-tenancy? 8-2
Can I open both the Global Portal homepage and the Oracle Argus Safety application in
my browser? 8-2
Can I open the Oracle Argus Safety application a second time for the same or a different
tenant? 8-2
Can I open the Oracle Argus Safety application for different tenants? 8-3
Can I launch different Oracle Argus applications in separate browser windows? 8-3
Is there a Japanese version of the Global Portal homepage? 8-3
Which actions can I perform from my global worklist? 8-3
Can I perform actions on multiple cases from my global worklist? 8-3
Can I open Oracle Argus Safety cases for multiple tenants from my global worklist? 8-4
How can I close or exit from the Global Portal homepage? 8-4
What If 8-4
There are no items in my global worklist 8-4
I can't see cases for a tenant even though I used its Enterprise ID as search criteria for
my global worklist 8-4

xiii
 The results list from my global worklist includes case data items that are not referred to
by worklist menu actions 8-4
A case data item appears in my Oracle Argus Safety worklist, but does not appear in the
results list from my global worklist 8-4

9 Argus Unblinding Advanced

Unblinding Advanced - Options 9-1
Configure an unblinding profile 9-3
Execute an unblinding profile 9-7
View Argus Unblinding log 9-9

xiv
Preface
This preface contains the following sections:
• Documentation accessibility
• Diversity and Inclusion
• Related resources
• Access to Oracle Support

Documentation accessibility
For information about Oracle's commitment to accessibility, visit the Oracle Accessibility
Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Diversity and Inclusion

Oracle is fully committed to diversity and inclusion. Oracle respects and values having a
diverse workforce that increases thought leadership and innovation. As part of our initiative to
build a more inclusive culture that positively impacts our employees, customers, and partners,
we are working to remove insensitive terms from our products and documentation. We are also
mindful of the necessity to maintain compatibility with our customers' existing technologies and
the need to ensure continuity of service as Oracle's offerings and industry standards evolve.
Because of these technical constraints, our effort to remove insensitive terms is ongoing and
will take time and external cooperation.

Related resources
For information about Oracle Argus patches, see My Oracle Support.
All documentation and other supporting materials are available on the Oracle Help Center.

Access to Oracle Support

To receive support assistance, determine whether your organization is a cloud or on-premises
customer. If you're not sure, use Support Cloud.

Cloud customers receive support assistance through Support Cloud

Oracle customers that have purchased support have access to electronic support through
Support Cloud.
Contact our Oracle Customer Support Services team by logging requests in one of the
following locations:
• English interface of Oracle Life Sciences Support Cloud (https://hsgbu.custhelp.com/)

xv
 Preface

• Japanese interface of Oracle Life Sciences Support Cloud へようこそ (https://hsgbu-

jp.custhelp.com/)
You can also call our 24x7 help desk. For information, visit Life Sciences Support | Oracle or
visit Oracle Accessibility Learning and Support if you are hearing impaired.

On-premises customers receive support assistance through My Oracle Support

Oracle customers that have purchased support have access to electronic support through My
Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info
or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

xvi
1
Know your basics
In this chapter:
• Product overview
• Log in
• Change your password
• Begin on the Personal Argus Status page
• Use the Quick Launch Toolbar
• Use field validations
• Acceptable date formats
• Use other (than English) language text
• Enter reasons for missing (Null Flavor) data
• Dynamic workflow indicator
• Case form user preferences
• Scale and Layout
• Integrate with Oracle Argus Insight
• ETL status for enterprise products
• Log out
• FAQs

Product overview
Argus Safety is a complete pharmacovigilance software system designed to solve the
pharmaceutical industry's toughest regulatory challenges. Argus Safety supports drug safety
business processes from an easy-to-understand user interface.

Log in
1. Open your browser and enter the URL for Oracle Argus Safety in the address bar.

Note:
Contact your System Administrator for the Oracle Argus Safety URL.

2. When the login screen opens, perform the following:

a. Enter username and password.
b. Select a value from the Database drop-down list.
c. Click Login.

1-1
 Chapter 1
Change your password

Autofill password: If the password save option is enabled in modern browsers,

Oracle Argus Safety allows to select a saved password during the login. When you
type the username, the Password field displays the hidden password for the selection
and you can log in without actually typing the password.

Note:
We recommend that you don't use the password save option.

The default Home page set by the Administrator appears. This can be the Personal Argus
Status page or one of the worklists, depending on user preferences defined in the Argus
Console.

Note:
If you receive a message as System is currently down for
maintenance. Please contact your system administrator for
more information., it implies that the system is being updated for necessary
updates to streamline operations and improve performance. During this period,
DB Jobs, ESM or AG Services, or Other Windows Services will not be able to
perform their functions
You will be able to login only when you have Global Admin user access rights,
and perform the following actions:
• Access the Argus Console.
• Open Case Forms and work on them.
• Book In new cases via case form.
• Initiate Meddra Recoding from self service.

Scale and layout

• The supported screen scale (zoom) is 100%. If the scale is not set to 100%, it may lead to
distortion or truncation of the user interface.
• The recommended layout (display resolution) is minimum 1280 x 1024.
• Depending on the medium of device used (monitor, laptop, etc.) the supported layout may
vary. Set the resolution according to your monitor settings.

Note:
Disable the pop-up blocker in the browser's advanced settings. Disable Save
and fill addresses in your browser's settings.

Change your password

1. Hover over the Utilities menu, and click Change Password.
2. Enter your current password in the Old Password field.

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 Chapter 1
Begin on the Personal Argus Status page

3. Enter the new password in the New Password field, and confirm the new password by re-
entering it.
4. Click OK.

Note:
This capability is available when the user ID and password are maintained in Oracle
Argus Safety and does not apply if your Oracle single sign-on is enabled.

Begin on the Personal Argus Status page

The Personal Argus Status page displays the cases assigned to you, your Contact Log entries,
your pending action items, and any overdue action items.
• To view your assigned cases, check the Cases Assigned checkbox.
• To view your Contact Log entries, check the Contact Log Entries checkbox.
• To view your pending action items, check the Action Item Entries checkbox.
• To view your overdue actions items, check the Overdue Action Items checkbox.

Note:
If the Personal Argus Status page is not your Home page, hover over the
Dashboards menu and click Personal Argus Status.

Use the Quick Launch Toolbar

The Quick Launch Toolbar is on the top right side of the screen.

Figure 1-1 Quick Launch Toolbar

Place the cursor over each icon to view the tool tip, which describes the role of each icon.

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 Chapter 1
Use field validations

Note:
Shortcut keys are driven by a combination of common profile switches and menu
access rights. For the example:
The Case Save shortcut/icon is visible only to users who have been granted
access to save the case in the group configuration. If the menu option is
disabled in the group configuration for a user, the respective shortcut /icon
is also removed.

Certain shortcuts/icons such as Field Validation are enabled only through a

common profile switch. Shortcuts/icons that are driven through common profile
switches are global to all users and are not controlled by group permissions.

Icon Tool Tip Description

New Case Displays the Initial Case Entry dialog box.

Open Case Displays the Case Search dialog box.

Worklist Displays the Worklist dialog box.

If no default Worklist option is defined, then Worklist - New
is displayed.

Use field validations

1. Click the icon next to a field to view its corresponding Field Justification dialog box.
2. This dialog box asks the user for a justification to perform the selected action. To overwrite
the warning:
• Enter a specific reason.
OR
• Select a standard reason from the message box.
3. Click OK to overwrite the field justification warning.
The orange icon changes to green.
The fields in the application are either required or optional. Each field type displays with a
different colored icon:
• A red icon signifies that a mandatory validation check has not been met.You need to
correct the data entry before being able to save a case.
• An orange icon signifies that an optional validation check has not been met. You need to
enter justification but can then continue to save the case.

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 Chapter 1
Acceptable date formats

Acceptable date formats

Several fields in the Oracle Argus Safety user interface enable you to enter dates. Fields that
accept full dates appear in the dd-mmm-yyyy format.
Appropriate formats for entering English dates are as follows:
• DDMMMYYYY where MMM is the three-character abbreviation for the month (such as
MAR, APR, JUN, and so on.)
• DDMMMYY where MMM is the three-character abbreviation for the month and YY is the
two-digit numeric value for the year (such as 09, 10, and so on.)
• DDMMYYYY where MM is the two-digit value identifying the month (such as 01 = January,
02 = February, etc.) and YYYY is the four-digit value for the year.
The dot (.), dash (-) and backslash(/) are acceptable separators.

Use other (than English) language text

Certain fields on the Case Form let you enter text in languages other than English. The non-
English text that is entered in these fields can also appear on Expedited reports.

Note:
When a case is in a specific workflow state, for which the parameter Enable multi-
lingual fields in locked case is set in the workflow configuration, then the
Multilingual dialog boxes are enabled for data entry, even when the case is locked
globally or locally.

To enter text in a language other than English:

1. Click the English language icon.
2. Use the pane associated with English to enter the English language text. Select the
required language from the Select Language drop-down list to enter text in that language.
3. After completing text entry, you can perform a spell-check for the text.
The table below displays icons representing different languages.

Icon Language
English

Japanese

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Use other (than English) language text

Icon Language
Language other than English or Japanese

For more information, see:

• Text translation

Text translation
You can use the multilingual dialog box to translate text from English to any local language and
vice-versa.

Note:
Translation from one local language to another local language is not supported.

You can select your local language from the Language dropdown.

The Translate buttons are available in the multilingual dialog box only if the Enable
Translation Service option is enabled in Argus Console > System Configuration > Webservice
> Bridge Configuration > Translation. If that option is disabled, the Translate buttons are not
visible on the screen.

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Use other (than English) language text

The Translate button is also disabled when there is no text entered in any of the language
textboxes (English /Selected Language), as seen below:

If you clear the entered text from either one of the language textboxes, or if you do not select a
language from the dropdown list, then the Translate buttons are disabled.

Multilingual dialog supported fields

The following fields in Argus support translation by using the multilingual dialog box:

No. Case Form/ Console location Field name

1 General tab > Reporter Information Reporter Institution
2 General tab > Reporter Information Reporter Notes
3 General tab > Reporter Information First Name
4 General tab > Reporter Information Middle Name
5 General tab > Reporter Information Last Name
6 Patient tab > Patient Information Patient Notes
7 Patient tab > Patient Information Initials
8 Patient tab > Relevant Tests Patient Relevant History Tests
9 Patient tab > Other Relevant History Relevant History Notes
10 Patient tab > Pregnancy Information Delivery Notes
11 Parent tab > Other Relevant History Parent Relevant History Notes
12 Products tab > Product Information Product Name
13 Products tab > Product Information Product Generic Name
14 Products tab > Product Information Product Notes
15 Products tab > Product Indication Product Indication as reported
16 Products tab > Product Details Related Device Comments
17 Products tab > Device > Device Information Device Comments
18 Events tab > Event > Event Information Event Description as reported
19 Events tab > Event > Details Event Details
20 Events tab > Event > Cause of Death and Autopsy Death Cause as reported
Results
21 Analysis tab > Analysis > Case Analysis Evaluation in light of similar events in the
past

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Enter reasons for missing (Null Flavor) data

No. Case Form/ Console location Field name

22 Analysis tab > Analysis > Case Analysis Case Comment
23 Analysis tab > Analysis > Case Analysis Abbreviated Narrative
24 Analysis tab > Analysis > Case Analysis Narrative
25 Analysis tab > Analysis > Case Analysis Company Comment
26 Console > Business Configuration > Studies Study Description

Enter reasons for missing (Null Flavor) data

Null Flavors are used to describe the reason for missing data. ICH E2B(R3) and regional
agencies such as CBER, EMA, MFDS, and PMDA have published guidelines on the allowed
Null Flavors for various fields that are part of the E2B(R3) report. A Null Flavor set is a
collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors
in the Flexible Re-categorization Codelist.
Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor
button ( ) next to the fields. On clicking the button, a drop-down list appears and allows
you to select Null Flavor data as configured in the Field Properties Configuration in the Argus
Console. The background color of the NF button changes (from grey to blue) when a Null
Flavor is selected from the drop-down list.
When the Case Form field has data and the user clicks the button, the system displays a
warning message that data will be cleared on switching to the Null Flavor field. The data is
cleared or retained based on user confirmation. When data pertaining to the field is received,
Null Flavor data can be overwritten by actual data by clicking the NF button.

Dynamic workflow indicator

Dynamic workflow indicators track the amount of elapsed time it takes to complete a workflow
step.
• The first number represents the time left or exceeded for a given workflow step.
• The second number indicates the time left until the reporting deadline.
• Time is expressed in days (d), hours (h), and minutes (m) respectively.
The icon changes based on the amount of elapsed time for the workflow step.

Icon Denotes
Traffic Light No status can be indicated. For example, when no timing is defined in the
workflow.
Red Traffic Light The timing has been exceeded.
Yellow Traffic Light The timing is in danger of being exceeded.
Green Traffic Light The timing is in good standing.

If the time to complete the case process exceeds the allocated time, the value is displayed in
red with the time displayed as a negative value. Only archived, locked cases do not display
the dynamic workflow indicator.

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Case form user preferences

Case form user preferences

The application lets you return to the same location on the tab after you tab to a different form.
For the example:
You are on the 8th reporter in the Reporter Section on the General tab and move to
another location in the application. When you return to the General tab, you are
automatically directed to the 8th Reporter as it was the last Case Form location that
you accessed before moving out of the Case Form.

User preferences are only applicable during the same session for a case, irrespective of the
case status (read-only or editable). If you exit from the case and open a new case, the user
preferences are reset.
Quick navigation
Each page displays the navigation flow to access the page.

Shortcut Key Output

CTRL+SHIFT+# Directs to the tab indicated by the # entered. (1=General tab, 2=Patient tab,
etc.)
ALT+SHIFT+# Directs to the sub-tab as indicated by the # entered (= Product 1, Product 2,
etc.)

Note:
The maximum # for the sub entities is 10 which
pertains to ALT+SHIFT+1 for the first entity within
the tab till ALT+SHIFT+0 for the 10th entity within
the tab.

Scale and Layout

The supported scale (zoom) is 100%. Consider the following:
• Distortion or truncation of UI display of Argus may occur if scale is not set to 100%. The
recommended display resolution is minimum 1280 x 1024.
• Depending on the device used (monitor/laptop/etc.), the supported layout may vary. Set
the resolution according to your monitor settings.
Disable the Pop-up blocker in the Advanced settings section of your browser.
Disable the Save and fill addresses option in the Settings section of your browser.

Integrate with Oracle Argus Insight

Oracle Argus Safety has the following integration points with Oracle Argus Insight. All these
integration points operate within the same enterprise for both Oracle Argus Safety and Oracle
Argus Insight.

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ETL status for enterprise products

Note:
This integration is available only to Argus Enterprise Edition users.

• Case Series Sharing: In case of multi-tenant installations, Oracle Argus Safety > Case
Actions > Case Open screen > Result from Argus Insight imports the
active case series for the user from the same enterprise partition of Oracle Argus Insight
which is currently opened in Oracle Argus Safety.
• Oracle Argus Insight Application Launch: The Oracle Argus Insight button in the main
Argus Navigation bar opens the same enterprise partition of Oracle Argus Insight which is
currently opened in Oracle Argus Safety.
For more information, see:
• Sharing a case series in Oracle Argus Safety with Oracle Argus Insight
• Sharing a case series in Oracle Argus Insight with Oracle Argus Safety

Sharing a case series in Oracle Argus Safety with Oracle Argus Insight
1. In the Case Search dialog box, search for and select a case in Oracle Argus Safety.
2. Open Oracle Argus Insight.
The system writes the case series belonging to the alert to the Argus case-sharing table.
3. Check Make Active from Argus to make the Case Search dialog box case series active in
Oracle Argus Insight.
4. If Oracle Argus Insight was already open, the Active Case series in Oracle Argus Insight is
replaced with cases from Oracle Argus Safety.

Sharing a case series in Oracle Argus Insight with Oracle Argus Safety
A case series can be made available from Oracle Argus Insight through Active Case series. To
share a case series in Oracle Argus Insight with Oracle Argus Safety:
1. Hover over the Case Actions menu and click Open.
2. Click Result from Argus Insight to create a search result with the same cases as the
Active Case series in Oracle Argus Insight.

ETL status for enterprise products

You can view the data migration status (ETL) from the Argus Safety source system to the
Enterprise Edition application target systems: Argus Insight, Argus Mart, and Argus Analytics.
This ETL status is displayed in a dashboard. The ETL Status dashboard is available for both
Argus English and Argus Japan users.
To view the ETL status, click Dashboards > ETL Status.

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ETL status for enterprise products

Note:
This menu option appears only when it is enabled from Argus Console > Access
Management > Groups > Menus > File > ETL Status.

• The ETL Status dashboard displays the most recent row from the frequently executed ETL
processes.
• For Argus Safety Standard Edition, a message appears as No ETL runs available.
• For Argus Safety Enterprise Edition, both new installations and post upgrade:
– ETL status of the subscribed products is displayed. Unsubscribed product row does
not appear in the dashboard.
– When an ETL is not started, or no records are present for the product, then Not
Startedstatus is displayed.

Note:
When the ETL logs are cleaned up, the Not Started status is displayed in the
dashboard.

General information—field descriptions

Field Description
Product Displays the name of the Enterprise Edition application:
• Argus Analytics
• Argus Insight
• Argus Mart

Note:
If any product is not integrated, then
that option is not displayed.

Database Name Displays the database names of the enterprise product.

ETL Type Displays the ETL execution type.
• Initial—Performed initially, a full copy of the data set is
transferred from the source to the target system.
• Incremental—Performed on regular basis, changes made to the
ICSR cases in the Argus Safety source database are captured
from the last migration, including new records, updates to
existing records, and deletions.

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Log out

Field Description
Start Date (GMT) Displays start date and time of the initial or incremental ETL
execution.
Date is displayed in the DD-MMM-YYYY H24:MM: SS GMT format.

Note:
When the ETL Status is Not Started,
the Start Date column remains blank.

End Date (GMT) Displays end date and time of the initial or incremental ETL
execution.
Date is displayed in the DD-MMM-YYYY H24:MM: SS GMT format.

Note:
• When the ETL status is In-
Progress, Not Started, or
Unknown, the End Date column
remains blank.
• When the ETL status is
Completed or Failed, the End
Date displays the date and time.
• For Argus Insight, when the ETL
status is Failed, the End Date
column remains blank.

Status Displays the data migration status.

• Green circle—ETL execution has completed successfully.
• Yellow circle—ETL execution is in-progress.
• Red circle—ETL execution has failed and stopped due to
errors.
• Blue circle—ETL execution has not started.
• Grey circle—ETL execution status is unknown and cannot be
retrieved due to communication link error.
When the status is Failed (red circle), an error link appears in the
Status column. Click this error link to view details.
Refresh Click Refresh to retrieve the recent ETL execution status from the
respective databases.

Log out
In the upper-right corner of any page, click Logout.

FAQs
• What happens if I enter a wrong password?
• Why can't I change my password?
• How do I get help?

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FAQs

• How do I view contents of the generated PDF when it contains uncommon or unsupported
characters?
• How do I trigger autocalculation?
• How do I generate batch reports?

What happens if I enter a wrong password?

The password is case-sensitive.
If you enter an incorrect username or password several consecutive times, based on the
current settings, Oracle Argus Safety then performs one of the following:
• Disables the Login button and displays a warning message.
• Locks your account. If this occurs, you must contact your company Administrator to unlock
your account. If you are still unable to login, please contact My Oracle Support.

Note:
The number of failed login attempts for log in of is configurable from Argus
Console > System Configuration > System Management (Common
Profile Switches) > Security > Number of consecutive failed
login attempts before account is locked out.

Note:
In all other places in Oracle Argus Safety where you are prompted to enter a
password for critical operations like lock, unlock, route, delete, if the failed log in
attempts reaches three, the session will expire, but your username will not be locked.

Note:
The application sends an email for Invalid Log-in entries to a pre-configured email
address that specifies the username used for Login along with the terminal from
where the user tried to login to the system.

Note:
If you still cannot log in and you do not receive the Login Error dialog box, verify that
the Pop-up Blocker functionality is disabled for your browser.

Why can't I change my password?

You may have exceeded the number of wrong entries. Ask your Administrator to reset your
password.
If you are logged in and the password change has not been accepted, hover over the Utilities
menu and select View the Error Log under Logs for details.

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FAQs

How do I get help?

To get task-based help, click Help on the top-right frame of the window. This takes you to the
respective product page on Oracle Help Center.
To get field-level help on the Case Form, double-click the label associated with the field to
obtain information about that field.

How do I view contents of the generated PDF when it contains uncommon

or unsupported characters?
When the report generated from Oracle Argus Safety is viewed in Google Chrome or Microsoft
Edge, there is a possibility that some characters are missing in the output. To view the
generated PDF that may contain characters in language other than English, make sure the
Acrobat reader extension is enabled in your browser. Save the generated PDF to your local
drive, and use Acrobat reader to view the contents.

How do I trigger autocalculation?

In general, you trigger autocalculation when you use the Tab key to move from field to field.
Some examples of autocalculation include check box selection and case save.

How do I generate batch reports?

The Batch Reports dialog displays a list of those batch reports that have been scheduled for
generation.
To view a list of batch reports:
1. Select Batch Reports from Utilities in the menu bar.
2. The system opens the Batch Reports dialog box with a list of batch reports along with
their report titles and next run dates.
To delete a batch report from the list:
1. Select the check box corresponding to the batch report to delete.
2. Click Delete.

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Enter case data
In this chapter:
• Create a new case
• Enter general information
• Enter patient information
• Enter product information
• Enter event information
• Add attachments to your case
• Review local labeling
• Enable local data entry for Japan

Create a new case

When your company receives new adverse event data, you need to enter this information and
check for duplicates before saving a case in Oracle Argus Safety.
You can create a new case by doing either of the following:
• Select Case Actions, and click New.
• Select Worklist, and click Intake.
For more information, see:
• Enter a new case
• Initial case entry—fields descriptions
• Check for duplicates
• Initial case entry—BookIn dialog box
• Accept incoming cases

Enter a new case

From the Initial Case Entry form, you can decide to book in a case before entering further case
information in the Case Form.
To enter a new case:
1. On the Home page, hover over the Case Actions menu and click New.
2. On the Initial Case Entry page, enter the mandatory information (fields with a red flag) and
click Continue.
3. Click Search to confirm this is not a duplicate case.
4. A list of cases that match the criteria you entered on the form is displayed along with their
duplicate search score. Review the search results for a duplicate case.

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If a duplicate case exists, open the case to enter further information related to the existing
case. Click the link associated with the case.

Note:
If the Enable Smart Duplicate Search switch is enabled in Console >
System Configuration > Common Profile Switches > Case
Processing > Duplicate Search, then the application uses the smart
duplicate search algorithm to execute duplicate search on the Initial Case Entry
screen, else the existing duplicate search algorithm is used.
Besides, the Score field appears in the result only when this switch is enabled.

5. If a duplicate case does not appear, click Continue in the Initial Case Entry form to display
the BookIn and Attachments and References sections.
When a duplicate search is performed, the system remembers the results until the user
logs out of the system or performs a duplicate search again. When the Bookin screen is
opened, the search results from the last search are displayed again.
6. Enter the relevant information in the following sections:
• Under Reported Causality, select the reporter's assessment of causality. The
causality relationship is the causal relationship between the clinically most important
event and the suspect drug that is entered in the Initial Case Entry form.
• For Seriousness Criteria, check the appropriate checkboxes to indicate the
seriousness of the case, as appropriate.
• Attachments and References
To insert a file attachment
a. Click Add on the Attachments and References tab.
b. Enter the Classification and Description, as applicable. Select File Attachment from
the drop-down list and click Add.
c. On the File Attachment -Web page dialog box, double-click Browse and navigate to
the relevant file. Click OK.
Contact your system administrator to configure this location.
To insert a URL Reference
a. Select URL Reference from the drop-down list.
b. Enter the URL after http://.
To search for and insert a document
a. Select Documentum Link and click Add.
b. The Document Lookup dialog box is displayed.
You can search for a document from the database by specifying a search criterion in
this dialog box.
7. Click BookIn.
Once clicked, this button is hidden from the screen. The button is enabled only if the Save
operation fails or when the case is booked-in successfully.
8. If the application has been configured to generate a case number automatically, it is
generated now.

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Create a new case

If the case number is not automatically generated, enter it according to your company
guidelines.
9. When the case creation message appears, click Yes.

Note:
If you click Yes, the Case Form page appears. You can now enter case data.
If you click No, the case is saved and closed. You can open the case and enter
data at any time.

Initial case entry—fields descriptions

Field Description
Initial Receipt Date Enter the complete date on which your company became aware of the case. The
Receipt Date cannot be entered as a partial date.
Central Receipt Date Enter the date on which this information was received by Central Safety.
Country of Incidence Select the country where the adverse event occurred. This may or may not be the
reporter's or the patient's country of residence.
Report Type Select the item that best describes the type of report. This determines the fields
that are made available for entering case information.
The report type also impacts duplicate search. For example, selecting
Sponsored Trial makes the Study ID and Protocol ID fields available. The
Administrator can adjust the information in this list.
Study ID(applicable Click Select to choose the study ID from the Clinical Trial Selection dialog box.
to clinical trial cases
only)
Center ID Click Select to choose the Center ID from the Clinical Trial Selection dialog
(applicable to clinical box.
trial cases only)
Initial Justification The values of this field are configurable through the standard Justifications dialog
box. This field is reflected in the General tab of the Case Form and is also
available for duplicate searching for cases.
Click the green dot to view and select justifications from the Justification dialog
box.
Product Name If the adverse event(s) are associated with more than one product, each
additional product can be added from the Case Form.
Enter the most suspect product here. Click Select to search for a product from
the Trade Name Product Lookup dialog box. Several items are automatically
entered on the Case Form based on the product selected here.
Generic Name This field can be used to enter the generic name of the product. This field is
automatically entered when a product is selected from the Trade Name Product
Lookup dialog box.

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Field Description
Batch/Lot # In this field, you can enter the batch or lot number in a free-text form to search for
duplicate cases. The search is performed on the following case fields:
• Drug > Dosage Regimens > Batch / Lot #
• Device > Device Information > Lot
• Vaccine > Vaccine Information > Batch / Lot #

Note:
The Dose # field from Vaccine > Vaccine
Information > Vaccine History is not included in the
search.

Description as Enter a brief verbatim description from the reporter describing the event that is
Reported most clinically important in the case. The icon denotes that the event is encoded.
Click the icon to populate the MedDRA hierarchy dialog box.
Onset Date/Time Enter the date/time for the onset of adverse event symptoms.
ID Enter the value to search for a Reporter Reference number, Case Reference, and
Case number.
Journal and/or Title These items are applicable to literature cases only. Click Select to choose a
journal and/or title from the Literature Reference dialog box. The Administrator
can adjust this list.

Check for duplicates

1. Enter the information related to the case in the Initial Case Entry form.
2. Select the Receipt Range Limits option to check for duplicates based on the dates
entered in the form and click Search.
If the Enable Smart Duplicate Search switch is enabled in Argus Console > System
Configuration > Common Profile Switches > Case Processing >
Duplicate Search, then the application search records based on the Smart Duplicate
Search algorithm, otherwise the existing duplicate search algorithm is used.
3. Review the list to determine if any case contains duplicate information.
For more information, see:
• Receipt range—fields descriptions
• Smart duplicate search

Receipt range—fields descriptions

Field Description
No date 90 days before System Date and 2 days after System Date.
Full Onset Date 10 days before Onset date and 90 days after Onset Date.

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Field Description
Full Initial Receipt 60 days before Initial Receipt Date and 60 days after Initial Receipt Date.
Date

Note:
This default date range for searching on Initial
Receipt Date can be disabled by un-checking the
Receipt Range Limits option on the Initial Case
Entry dialog box.

Partial Onset Date Based on the Full Date Range - if only the year is entered, the date range
becomes: 10 days before the end of the previous year and 90 days after the end
of the year.
Partial Initial Receipt Based on Full Date Range - if only a year is entered, the date range becomes: 60
Date days before the end of the previous year and 60 days after the end of the year.

Note:

• If an Initial Receipt Date is not entered but an Event Onset Date has been
entered, the search will default to look for cases with Initial Receipt Dates 10
days before and 90 days after the Event Onset Date. This feature can be
disabled directly on the dialog box by un-checking the Receipt Range Limits
checkbox. If you do not check anything, the default date range is 90 days before
and 2 days after the current date.
• The Duplicate Search permits you to sort in ascending or descending order in the
duplicate search results. You can also use wildcard searches on all text fields in
the Book-in dialog box.

Smart duplicate search

The smart duplicate search considers all the values present in the incoming record or search
criteria to find the potential matching records. It returns the matching case record, even if some
of the values in search criteria do not match as those values do not contribute to total match
score.
The application uses this algorithm only when the Enable Smart Duplicate Search switch is
enabled in Argus Console > System Configuration > Common Profile
Switches > Case Processing > Duplicate Search, and displays a record match
score in the Score field. By default, the search result is sorted in the descending order of the
score.
If the Enable Smart Duplicate Search is not enabled, the duplicate search does not return a
record even if a single criteria does not match. For example, if all the search criteria values are
matching to a record except patient age, then the duplicate search does not return this case
record, while the smart duplicate search fetches this record in the search results for a total
match score above the predefined score threshold. Hence, the smart duplicate search reduces
the number of search iterations making the process more efficient.

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Note:
This switch is global that is, any changes made to this switch impacts all the
enterprises.

Score Threshold
A threshold value is defined in Argus Console > System Configuration > System
Management (Common Profile Switches) > Case Processing > Duplicate
Search. While searching for a case record, the smart duplicate search algorithm displays
matching records having a score of predefined threshold or more. The threshold is also
referred as the record level score threshold.

Note:
This switch is set at the Enterprise level. Any changes made to this switch impacts
only that enterprise.

Smart search algorithm

The smart search algorithm use fuzziness such that you can enter all the search criteria at
once and the records are returned based on the total score. It is possible that one or more of
the search criteria does not match a record in the result, but still appears in the results list, if
the total score is higher than the configured threshold.
For example, if the record threshold is 50, then only matching cases with score of 50 or more
are displayed in the list.
The following are the main features provided by the smart search algorithm:
• Numerical Scoring - Smart Search algorithm applies numerical scoring to the numeric
and date fields, so that, the entered search criteria matches the value in the case record, if
the value is within pre-defined threshold.
For example, for a threshold of 1 month, the patient age of 12 months should match 11
months. Similarly, for a threshold of 15 days, the Event Onset date 10-Jan-24 should
match 20-Jan-2024.
The lower is the deviation between the search criteria and the matching value, higher is the
score contribution, and vice-versa.
• Soundex - A feature to match misspelled text fields or names with similar sounds is
available using the Full Search check box on the Initial Case Entry screen.
• Weighted Matching - Each matching attribute contributes differently to the scores based
on the pre-configured weight.
For example, if Patient DOB has more weight configured than Patient Age, then the Patient
DOB field contributes more to the total score than the Patient Age field.
• Transposed Date Matching - Transposed date, that is, date with day and month swapped
is also considered as a match with more score to an original date than the transposed
date.
For example, Patient DOB: 10-Jan-2024 matches 01-Oct-2024.

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Note:

– Date thresholds are applied to date as well as transposed date.

– Date limits are calculated based on the input date and not based on the
transposed date.
– Records with transposed date are considered if they are within the date
limits, else they are excluded. For example:
For the initial receipt date of 03-Jan-2024, the receipt range limit is 04-
Nov-2023 to 03-Mar-2024. In this case, the transposed date 01-Mar-2024
falls within the date limits calculated from 03-Jan-2024.
Whereas, in case of the initial receipt date of 10-Jan-2024, the receipt range
limit is 11-Nov-2023 to 10-Mar-2024 and the transpose date 01-Oct-2024
does not fall within the date limits. Hence, the record with the transposed
date is not considered as a match.

• Exclusion Criteria - This is to ensure that there are no performance issues. If any of the
following fields do not match, then the record is excluded from the search results:
– Report Type
– COI
– Gender
– Initial Receipt Date

Note:
As the above fields are part of the exclusion criteria, and hence these fields do
not contribute to the match score, and do not show up in the Match Score
Explanation screen. However, the Initial Receipt Date field is an exception as this
field contributes to the match score as well as appear in the Match Score
Explanation screen due to numerical scoring.

Match Score
To understand the score value, from the duplicate search results, click Score of the selected
record. The Match Score Explanation screen appears with the fields for which search criteria
has been entered.
The Match Score Explanation screen shows comparison of the values, which are searched
with the corresponding values in the matching case record. You can also view the contribution
of each field to the total match score along with the match type, that is, if it is an exact match,
similar values, or no match; so as to take a decision on whether the incoming record is a
duplicate or follow-up of the selected record or not.

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Note:
The match score also depends on the number of search terms. The significance of
number of terms in the search criteria diminishes with the increase in search terms.
However, for a lower number of search terms like searching only by Reporter's First
Name as the search criteria may return a very less score (as low as 5), even on the
exact match. Hence, Oracle recommends to search with more basic available
information for the case rather than searching on only one field.

If the Reference ID or case number matches, then this field is prioritized over the rest of the
fields and the case record is considered as a match with 100 score ignoring the match score
contribution for rest of the fields. Match Type is the Camel Casing in this scenario.
Total score for the record is rounded off to a whole number, and hence there can be round off
error between the sum of individual field scores and total score.
Reference ID field, if available in the search criteria, is always the first field in the Match Score
Explanation screen.

Field name Description

Search Criteria Displays the values in the search criteria or incoming record being
searched against.

Note:
Only duplicate search fields that are
checked and have values in the incoming
record or search criteria are displayed.
Exclusion Criteria fields are not displayed
in the Match Score Explanation screen as
these fields do not contribute to the total
score.
The Initial Receipt Date field is always
displayed, if entered as search criteria or
present in the incoming record.

Selected Record Displays the value for the matching case record.
For example, if the search criteria matches Patient First Name, then
only First Name is displayed under Selected Record.
• In case of no match, Patient First Name and Last Name are
displayed separated by space.
• If only Patient First Name or Last Name is available, then non-blank
values are displayed.
• If Patient First Name and Last Name, both are blank, then Patient
Initials are displayed. If patient initials are also unavailable, this field
is left blank.
Score Displays individual contribution to the total score by each field. It helps
to understand how much each field has contributed for the record to be
a match.
Individual field score is rounded-off to 2 decimal places.

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Field name Description

Match Type Displays type of the values that are matched:
• Priority Match - If the fields with high priority matches, like
Reference ID.
In case a record is a priority match, the Match Type is displayed as
N/A as well as Score for rest of the fields in the search criteria.
• No Match - A criterion that is used during the search, but the
searched value do not match the value in the duplicate search
result case record being assessed.
• Exact Match - A criterion that is used in the search, where the
value in the duplicate search result case record being assessed
matches exactly.
• Similar Values - A criterion that is used in the search, where the
intent of the values match, but are reported or captured as other
similar values that are close to the value searched (such as dates
within range, age ranges, Soundex, etc.). For example:
– Soundex: “Johnson” vs “Jonsen”
– Misspelling: "Headahce" vs. "Headache"
– Date Range match: “20-Nov-2023” vs “21-Oct-2023”
As Argus uses Oracle Text which is designed to match information
based on the text (word) entered, if there are fields with same value
and are variants, then also the record is considered as a similar
match, and assign them with same score. For example, if a record
has symptom as Rash, and the other one has Severe Rash, then
both the records are considered as similar match, and assigned
same score.

Initial case entry—BookIn dialog box

• You can enter the attachment classifications and their descriptions on the Initial Case entry
dialog box.
• The values entered in the Classifications and Description fields are transferred after the
cases have been booked.
• When you book in a clinical trial case and select a study where the country of incidence
value does not match the list of countries defined in the study configuration, a warning
message appears.
• Right-click the row, and select one of the following:
– View Case Summary
– Print Medical Summary—Displays the Medical Summary report PDF. If you do not
have access to the Medical Review dialog box, the Medical Summary Report is
hidden.
– Print—Launches the Case Form print dialog box. If you do not have access to the
Case Form print dialog box, the Print Case option is hidden.

Accept incoming cases

The Intake function enables you to view a list of incoming attachments in the Worklist View
where you can select an attachment for creating a case.
To access the Worklist > Intake page, hover over the Worklist menu and select Intake.
For more information, see:

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• View pending case

• View rejected cases

View pending case

Use Pending tab to create a case, reject a case, and so on. Users other than Workflow
Managers can reject a case from the Intake Worklist.

Field Description
Priority Allows the user to view the priority of the case.
Case Type Allows the user to view report type information.
Reporter Type Allows the user to view the Reporter type for the Primary Reporter in the case.
Group Allows for the current group owner or Unassigned group to be assigned to the
case.
Central Site/LAM Site Allows the user to view the current Site (Oracle Argus Safety or Oracle Argus
Affiliate) of the Case - If there are no Sites defined, ALL users can access the
case attachment.
Attachment Name Allows the user to view the attachment which is associated to the case.
Classification Allows the user to view the attachment classifications which is associated with
the case.
Description Allows the user to view the attachment description which is associated with the
case.

View rejected cases

Field Description
Generic Name Allows the user to view the generic name of the suspect product in question.
F, LT or H Allows the user to view Fatal, Life-Threatening or Hospitalized cases.
Reporter Type Allows the user to view the Reporter type for the Primary Reporter in the case.
Country Allows the user to view the Country of incident.
Classification Allows the user to view the attachment classifications which is associated to the
case.
Description Allows the user to view the attachment description which is associated to the
case.
Rejected Date Allows the user to view the date when the case was rejected.

Enter general information

The General tab captures the case information in categorized sections for category-specific
information. It also enables you to enter or view information such as the type of report,
literature information, and so forth.
• If a priority has not been assigned to a case, the Case Priority field is hidden.
• If a case owner has been assigned to the case, the name of the case owner appears at the
top of the Case Form.
For more information, see:
• General information—field descriptions

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• Enter study information

• Enter reporter information
• Enter literature information

General information—field descriptions

Field/Control Name Description
Report Type Select a report type that determines the availability of fields relating to
clinical studies and literature references.
The Clinical Study report prompts for information relating to the study,
and literature-based reports enable to select the journal and reference on
which the case is based.
Country Select the country where the adverse event occurred.
Initial Receipt Date Enter the date your company became aware of the case. Oracle Argus
Safety uses this date throughout all reports.
This date can be changed only prior to regulatory report submission.
Central Receipt Date Enter the date on which this information was received by Central Safety.
Medically Confirm Specify whether the case was medically confirmed or not, by a healthcare
professional.
Initial Justification Enter the initial justification reason.
The entry in this field is displayed as per the reason entered when the
case is being booked in.
Amendments/Follow-ups On sorting by follow-up received dates, the serial number still displays the
order of entering the follow-ups. The follow-up information can be sorted
by:
• Serial Number
• Follow-up Received Date
• Central Received Date
Click the header to sort in ascending or descending order. By default, the
sorting is in descending order of the Follow-up Received Date.
You can add up to 500 enteries using the Add button.
Follow-up Received Date To enter the date on which amendment or follow-up information was
received by your company, click Add.
You can select whether the case has significant follow-up information by
confirming the message: Is this follow-up significant?.
When sorting on follow-ups, by default, the dates are sorted in
descending order.
Safety Received Enter the date on which follow-up information was received by Central
Safety. This field is disabled for an amendment and any prior data in this
field is cleared.
Significant Check this checkbox if the follow-up is significant.
Data Clean up Check this checkbox to mark the follow-up as a Data Clean up version.
This version is used in the Data Lock Point for Case Versioning in and
System Reports.
This field is disabled for an amendment and any prior data in this field is
cleared.
Amendment Specify if the case was updated without adding any new information.
This checkbox is enabled irrespective of whether the Significant checkbox
is checked.

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Field/Control Name Description

Amendment/Follow-up Select a pre-defined justification for Amendment or Follow-up.
Justification Click the icon to view the standard justifications dialog box. The
justification entered in the Amendment field is also populated in this field.
You can select a pre-defined justification from this dialog box or enter a
new justification.
Case Requires Follow-up Check this checkbox, if the case requires follow-up information.
When this field is checked, an action item is scheduled automatically for
the current user to request follow-up information.
Classification Select up to 50 case classifications used to categorize a case.
To enter additional case classifications, click Add.
When the Classifications field is hidden, the classification section is
hidden on the Case Form.

Enter study information

1. To choose from the available list of study information, click Select.
2. In the Clinical Trial Selection dialog box, enter Project, Study, and Center information.
The Clinical Trial Selection dialog box allows you to select a clinical trial from the list
configured by the administrator.
3. Click Search.

Tip:
To broaden the search results, enter as little information as possible. Select the
required clinical study and study center, and click Select.

4. Choose the study information from the list, and click Select.
The details of the selected Study Information are added to each field in the Study
Information section.
For more information, see:
• Study information—field descriptions

Study information—field descriptions

Field/Control Name Description

Project ID Enter the Project ID, or select one from the list.
Selecting a Project ID automatically creates items in the Study ID list.
Study Phase Enter the Study Phase for the configured study.
This field is pre-populated if you select a Study with an already-configured
Study Phase.

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Field/Control Name Description

Blinding Status The status is auto-populated based on the type of study.
You need special access rights to use any of the Broken By entries.

Note:
The Unblind Case dialog box appears when you
try to unblind a study. For Not Blinded studies,
saving the case or generating a report, you can
enter the actual drug (vs. placebo) given to the
patient.

Observe Study Type The value selected from this drop-down list is populated in the Case Form
Study Section when the Clinical Study is selected.
Unblinding Date Auto-populates when the blinding status is changed to Broken by Sponsor or
Broken by Investigator.
If you double-click the date in this item, the Unblind Case dialog box is
displayed. A significant follow-up is added and follow-up received date is
populated with date.
The unblinded date is not editable in the Unblind Case dialog box when
blinded status is changed to Broken by Sponsor whereas it is editable when
the blinded status is changed to Broken by Investigator.

Enter reporter information

Enter the information about the person providing the case-related information.
• The Reporter Rearrangement dialog box displays the number of Reporters present in the
case. It displays the First Name and Last Name, followed by the Reporter Type in brackets,
as entered in the reporter information dialog box.
• To view all the Reporters, click the Quick Launch icon.
• To view the details of the selected Reporter tab, click a Reporter Name.
• To add a new reporter, click the New tab. You can add a maximum of 100 reporters.
• The Primary Reporter is identified by the Reporter icon on the Reporter Information tab.
For more information, see:
• Add reporter information
• Reporter information—field descriptions

Add reporter information

1. In the Reporter Information section, click Select.
2. In the Reporter Lookup dialog box, enter the search criteria, and click Search.
• All filter criteria you have entered on the Reporter Look Up dialog box are saved as
user preferences while it populates the reporter information on the General tab.
– If you have reporter information in the case, the information appears in the
Reporter Lookup dialog box and search is performed.

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– After performing the search the search criteria is retained as user preferences. The
next time you perform a search, these preferences appear.
– When you log out, the user preferences are retained and are available the next
time you log in.
– To clear all the values in the filter elements, click Clear.

Tip:
You can choose to search either by Search Cases or by Search List
Maintenance.

3. From the search results, select the reporter information, and click Select.
The selected, pre-defined information is added to the fields.

Reporter information—field descriptions

Field/Control Name Description

Reporter Notes Click this button to enter free text notes relating to this reporter.
This field supports multiple language entries. Click a flag, select the language
tab, and enter information.
Institution Enter the institution's name.
This field supports multiple language entries. Click the multi-language icon to
display the languages window, select the target language from the drop-down list
at the top, and enter the text in the language fields.
Institution ID Enter the reporter's institution ID.
This field value is populated based on the Institution ID selected for the Reporter
from the Reporter Lookup dialog box. This field also allows to manually enter or
update the value directly in the Case Form irrespective of the value specified in
the Institution field for the reporter.
Manually entered Institution and Institution ID field values are allowed in the
Reporter Information section even if they are not specified or linked to each
other as per Console Institution code list.
Protect Confidentiality If this checkbox is checked, the name and address of the reporter does not
appear on regulatory reports and the reporter's information displays NAME AND
ADDRESS WITHHELD.
The MSK null flavor appears in the eVAERS report when this checkbox is
checked. MSK is populated only when the data element contains some data and
is not null.
Primary Reporter Only one primary reporter is permitted per case. The primary reporter is the
reporter whose name appears on the regulatory reports. The tab that identifies
the primary reporter is displayed in blue as compared to the other reporter tabs.
Correspondence If this checkbox is checked for a reporter, the reporter's address information is
Contact used in letters. You can select more than one reporter as the correspondence
contacts for the case.
Reporter ID If known, enter the Reporter ID. This completes the Case Form reporter fields.
Reporter Type, Report These lists are maintained by the administrator.
Media, and
Intermediary
(New) Tab Creates details for a new reporter.

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Enter literature information

You can enter a literature reference for a case manually or you can enter pre-defined literature
information.
1. From the list of available literature, click Select.
2. In the Literature Reference dialog box, select a reference in the list, and click Select.
The details of the selected literature information are added to each field in Literature
Information.

Enter patient information

You can enter patient information such as the patient's past medical history and current
conditions, and laboratory tests and test results.
For more information, see:
• Enter current medical status
• Copy patient information from reporter information
• Patient information—field descriptions
• Enter patient notes
• Enter patient details
• Enter patient death details
• Enter other relevant history
• Enter lab data—lab test and test results
• Enter additional test information
• Enter parent information

Enter current medical status

1. In the Case Form > Patient tab, click Current Medical Status.
2. From the items in the form, select the options that apply to the patient.
If you don't know whether a particular condition applies for the patient, select Unk.
3. To save the current medical status, click OK.

Copy patient information from reporter information

If the patient and the reporter are the same person, the reporter information entered in the
General tab can be copied to the Patient tab.
To copy the reporter information, click Patient Info From Reporter.

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Patient information—field descriptions

Field/Control Name Description
Child only Case If this checkbox is checked, then the pregnancy [Detail] button is accessible from
the Parent information tab only and no longer through the Patient tab directly.
Current Medical Captures details about the history and the current condition of the patient from
Status the dialog box.
The items that appear in the Current Medical Status dialog box are mapped to
the fields for the German BfArM tab on the Analysis tab. Changing the values on
the BfArM tab does not affect these items.
Name During book-in, the patient name is transferred to the relevant name and initials
(Title, First Name, MI, fields. If the Patient Name or Initials are three characters or less, this is
Last Name) transferred to the Initials field.

Number of Patients Enter the number of patients involved in the adverse event.
Pat. ID Enter the Patient Identifier number.

Note:
This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection
dialog box.
Protect Confidentiality If this check box is selected, the patient's name and address will not appear on
any of the regulatory reports and the patient's information will show the word
PRIVACY.
The MSK null flavor appears in the eVAERS report for patient's name and
address when this check box is selected. MSK is populated only when the data
element contains some data and is not null.
Randomization # Determines which drug was administered to the patient during the course of the
study.

Note:
This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection
dialog box.
Sponsor Identifier Enter the Sponsor Identifier of the patient.

Note:
This field appears for clinical trial cases only.

Tip: This field can be used while searching for cases in the Case Selection
dialog box.

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Enter patient notes

Click to enter free text notes relating to the Patient. If there is no text data for Patient Notes,
from the NF drop-down list, select Null Flavor.

Note:

This field supports multiple language entries. Click the icon to translate your
data from English to a different language or vice-versa.

Icon is displayed when there is no data in Patient Notes and NF data.

Icon is displayed when there is data in Patient Notes or NF data.

Enter patient details

Enter patient information, including pregnancy data.

Table 2-1 Patient Details—Field Descriptions

Field Description
Gender at Birth Enter the patient's gender at the time of their birth.
The available values for this field are controlled through MEDWATCH
attribute in the GENDER flexible code list as configured in Argus
Console.
Current Gender Enter the patient's gender they identify with.
The available values for this field are controlled through MEDWATCH
attribute in the GENDER flexible code list as configured in Argus
Console.
Ethnic Group Enter the patient's ethnic group such as Hispanic or Latino, Not
Hispanic or Latino, and so on.
Military Status Enter the details of the Military status of the Patient such as Active
Duty, Reserve, National Guard, TRICARE Beneficiary, and so on.
Race Select the patient's race. You can capture up to 5 Race using the Add
and Delete buttons.

Note:
You cannot select the same Race more
than once.

Pregnant at time of Vaccination Select Yes if the patient is pregnant at the time of vaccination.

For more information, see:

• Enter pregnancy information

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Enter pregnancy information

1. From the Pregnant drop-down list, select Yes.
This field is shown as active only after the Gender field in this section is selected as
Female.
The Pregnancy Information section appears.
2. Enter the available pregnancy information in the form.
3. Click OK.
4. In the Neonate Information section:
• To delete neonate information, right-click the neonate, and click Delete.
• The changes are tracked to the neonate information in the audit log.
The following list describes the fields on the Pregnancy Information and Neonate form.

Field/Control Name Description

Gestation Period Enter the gestation period when the reaction or event was observed in the
fetus. Select a unit for the gestation period from the accompanying drop-down
list.
Number of Fetus Enter data for a baby who is born to the patient.
To make an additional entry, click New.
Prospective/ Select if the information was Prospective or Retrospective.
Retrospective A prospective information is one where the company hears of the case before
the baby is born to the patient who took the drug.
In a retrospective case, a company gets to know after the baby is born.
Delivery Notes Enter baby delivery details.
This field supports multiple language entries. Click the multi-language icon to
display the languages window, select the target language from the drop-down
list at the top, and enter the text in the language fields.

Enter patient death details

Enter information about the death of a patient. For more information, see:
• Event death details—field descriptions

Event death details—field descriptions

Field/Control Name Description

Autopsy Done? If Autopsy Done is set to No or Unknown, the Autopsy Results Available is shown
as No.
Autopsy Results The Autopsy Results Available? field is enabled only if the Autopsy Done?
Available? field is marked as Yes.
If Autopsy Results Available? is changed to No, and Autopsy Result rows
exist, you will be asked to delete the rows first. Click Yes to delete the data.

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Field/Control Name Description

Add Click this button to add a Cause of Death and Autopsy Results row.

Note:
You can add multiple records, up to 50 entries.

Delete Deletes a highlighted row.

Enter other relevant history

Enter information related to past drugs administered on Patient, and Current Medical condition
of the patient.
To copy the Other Relevant History rows, select the row, and click Copy.
For more information, see:
• Other relevant history—field descriptions

Other relevant history—field descriptions

Field or Control Description

Name
Copy Enables you to copy a row. After you copy the row, the focus will be on the newly
copied row.
Add Enables you to add a row to the relevant history. After you add the row, the focus
will be on the new row.
Delete Enables you to delete a row from the relevant history.
Start Date Enter the start date of the condition. You can enter a partial date if the actual date
is not available. You can also choose not to enter a date.

Note:
If you click Add but do not enter a date, the Date
column is removed.

Once the date is entered and a test is associated with the date, you cannot clear
the date but can only modify it. To remove the date column, individually delete all
the cells in that Date column.
Stop Date Enter the stop date of the condition. You can enter a partial date if the actual date
is not available. You can also choose not to enter a date.
If you select Ongoing as Ye or Unknown, the Stop date is cleared and disabled.
Age and Units Age and Age units are enabled only for condition type with Patient Other
Relevant Therapy being set.
Family History Check this checkbox if this relevant history is reported to be present in another
family member. The Family History checkbox is enabled only for Condition types
that are mapped to Medical History Episode in the Condition Type codelist.

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Field or Control Description

Name
Substance Displays the substance name, term ID, and strength unit of the Product
Information separated by commas. If there are multiple records, they are displayed in
subsequent rows.
Name Part Displays the name part and name part type information. If there are multiple
records, they are displayed in subsequent rows.
Click Name Part button to enter Product Name Part Type and Product Name Part
details.
Product Name Parts Displays the Product Name Part information. Enabled only for condition type with
Information Patient Other Relevant Therapy being set.
Version Displays the Date or Version of the Product Identifier. Enabled only for condition
type with Patient Other Relevant Therapy being set.
Coded PT/ Enter a term to describe the condition. You can either manually encode or auto-
Description of encode if you have been so configured by the Administrator.
condition LLT/ In manual mode, type the description (for example, Fever).
Indication PT/
In Auto-encode mode, enter a partial description and press ENTER or TAB.
Reaction PT
The appropriate coding dialog box appears.
In either mode, click Encode and modify the encoding. If the condition type is
historical drug, the encoding will be done with WHO drugs.
Product Identifier Displays the type of Product Identifier such as MPID, PhPID, and so on. Enabled
Type/ Product only for condition type with Patient Other Relevant Therapy being set.
Identifier Version/ Displays the Date or Version of the Product Identifier. Enabled only for condition
MFDS Product type with Patient Other Relevant Therapy being set.
Code/WHO Medicinal
Enables you to add the MFDS assigned Product Code.
Product ID/Notes
Both MFDS Product Code and WHO Medicinal Product ID fields are enabled
only when the Condition Type is set to value configured for Patient Other
Relevant Therapy as Yes in Codelist > Condition Type.
These fields are disabled, when the Condition Type is set to value configured for
the Medical History Episode as Yes in Codelist > Condition Type.
When drug is encoded using the WHO-DD C3 format then the Medicinal Product
ID is populated in the WHO Medicinal Product ID field. If the drug is encoded
but already has a value entered in the WHO Medicinal Product ID field, then the
value from the Drug Coding browser is overwritten into the Medicinal Product ID
field.
When the drug is encoded using any other WHO-DD format where the Medicinal
Product ID is not available or displayed in the Drug browser, then the Medicinal
Product ID is not populated in the WHO Medicinal Product ID field and remains
Null. If you have entered any data in the WHO Medicinal Product ID field, then it
is removed when drug is encoded using any other WHO-DD format where
Medicinal Product ID is not available.
Encode Click this button to encode the term. Encode is used in multiple contexts such as
coding with MedDRA for reactions and indications, and coding for products using
WHO drug browser.

Note:
To view the complete MedDRA hierarchy for the
encoded term, click the encoding status icon.

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Field or Control Description

Name
Indication PT and This field is visible on the case form only if the condition type selected in the List
Reaction PT maintenance is Patient Other Relevant Therapy.
Ongoing Indicates whether the condition is continuing. If it is set to Yes or Unknown, the
Stop date is disabled.

Enter lab data—lab test and test results

The maximum number of lab test data on the Case Form is 1500.
1. To enter a Lab Test Name:
a. Click Add Test.
b. Enter the description, and click Search.
c. From the search result, select a name.
2. To select a Lab Test Group, click Select.
A list of the lab test that matched the selected group appears.

If lab test data is already in the case form, the lab test group is appended after the last lab
test.
3. To add more rows of Lab Test Data, right-click an empty cell, and click Add.
4. To copy a Lab Test Data, right-click the row to be copied, and click Copy.
5. To delete a Lab Test Data, right-click the row to be deleted, and click Delete.
6. To arrange entries in a specific order, click the Order icons.
7. You can sort Lab data in chronological order by Date of the Test and alphabetically by the
Test Name.

If there are partial dates entered, the date is displayed at the beginning of the month, and
year for the date entered.
8. To view the hierarchy of the Event Term, click the view icon.
9. To view Notes in a Zoom dialog box, click the view icon.
10. To arrange the Lab Test Data, click the arrow button to move data to left or right.

This is available only when the Lab Test is entered for the same date.
For more information, see:
• Lab data—field descriptions

Lab data—field descriptions

Field/Control Name Description

Norm Low/Norm High The Test Name list can retrieve details of the normal range for the test
selected (if the administrator has entered the normal range into the list).
Otherwise, enter the values manually.

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Field/Control Name Description

Result/Units Enter the test result, including units, and select a term to describe the
qualitative assessment of the results. The administrator can modify the list of
possible assessments.
If test results cannot be expressed in Result/Units or Assessment, enter the
data in Notes field.
You must enter Lab test result by using Results/Unit, Assessment or Notes
fields, and not in all the fields. Regulatory agencies may send rejection for
ICSR if data is sent in all formats.
Assessment Select a qualitative assessment term to describe the lab test results.
More Info Available Check this checkbox if there is additional information is available for this Lab
test in Additional Info tab.

Enter additional test information

Enter additional information about any relevant tests, such as toxicology.

Enter parent information

The Parent Information tab is similar to the Patient tab.
However, in the Other Relevant History section, the Family history, Age, and Units fields are
unavailable.

Enter product information

Enter and view details for products and dosage regimens. This tab contains the name of the
drug that has been entered here. For Blinded Studies, the Blinded Product Name field appears
in the tab.
If you do not have access to view unblinded information on the Case Form, some of the fields
are hidden.
If the study has been unblinded and a study drug had been selected, the selected Study Drug
Name is displayed. You cannot view unblinded information and the tab continues to show the
Blinded Product Name.
You can enter details of more than one product and more than one dosage regimen for a
company product for which multiple licenses exist (for example, drug and vaccine, or drug and
device).
Based on the type of license (drug, vaccine, or device), different views are available in the
Products tab. If the selected item is not a company product or if a license for a company
product does not exist, all three views are always available.
For more information, see:
• Search for products
• Enter time measurement information
• Enter drug information
• Enter device information
• Enter vaccine information

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Search for products

You can perform the following search:
• Product Browser based search
• WHO Drug Browser based search

Product Browser based search

1. In the Products tab, click Select adjacent to the product name.
The Product Browser dialog box appears.
2. Click the displayed entities.
The hierarchy above and below the entity being searched is also displayed. For the
example:
If Product Name is searched, it displays the Product Name as well as the Family Name
and Trade Name.

3. Search for Products based on the following criteria:

• Ingredient
• Family
• Product Name
• Trade Name—Searches the License Trade Name
4. To select all the search criteria, select the Full Search checkbox, and click Select.
5. Select a product from the search result.
6. To remove the entered search criteria, click Clear.

WHO Drug Browser based search

1. To open the WHO Drug Coding dialog box, click Encode adjacent to the product name.
2. In the Drug Coding dialog box, the dictionary is loaded based on the configuration of the
Case For Configuration common profile switch as mentioned here.
From the Case Form Configuration dialog box where the dictionaries are selected for
encoding, select either the WHO Drug B format or the WHO Drug C format.
When you select WHO Drug from the Drug Coding window, the Chinese Trade Name and
Chinese Generic Name are auto-populated in the Product tab > Product Name
and Generic Name fields in the multi-language window for Chinese language.
These fields are auto-populated only when the Chinese WHO Drug dictionary is loaded,
and set in the WHO Drugs (Chinese) common profile switch.
3. Enter the search criteria, and click Search.
You can search for a product based on:
• Trade Name
• Total Rows (#) - Total number of records are displayed as per the search result next to
Trade Name.
• Formulation/Strength (sequence 3 and sequence 4) of the product.

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• Country—The Sales Country Code of the Product as defined in the WHO Dictionary.
• Generic.
The following criteria are not available for display or searching in the WHO Drug B
Format:
– Formulation
– Country
– Strength
– MAH
– Generic
– Medicinal Product ID
– Product Type
4. To copy the selected drug to the Product tab, click Select.
5. To close the selection dialog box without making any updates to the Product tab, click
Cancel.
6. To perform a full search from the WHO Drug browser, select Full Search.
• By default, an exact search is performed (e.g., CUREALL)
• You can use the percent (%) sign to perform wildcard searches (e.g., CUREALL%)
• If you click Full Search, the full search is performed (e.g., %CUREALL%)
7. To clear the search criteria you entered, click Clear.
8. You can sort the results on all the fields.

Enter time measurement information

You can enter seconds in the following fields:
• Argus > Case Actions > Open > (Select a Case) > Event tab > Event
sub tab > {event description} sub tab > Event Information section
(middle of screen)
– Onset From Last Dose field
– Duration field
– Onset Latency field
• Argus > Case Actions > Open > (Select a Case) > Products tab >
Product sub tab > {Product Name} sub-sub tab (drug) > Dosage
Regimen section (lower 1/3 of screen)
– Duration of Regimen
• Argus > Case Actions > Open > (Select a Case) > Products tab >
Product sub tab > {Product Name} sub-sub tab (drug) > Product
Details section (lower 1/3 of screen
– Duration of Administration
– Time between First Dose/Primary Event
– Time between First Dose/Primary Event
• Any number following by the letter "s" defaults to "#sec."

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• The seconds entered in the form are interpreted in the following formats, where:
# is a number from 0 to 9
#s—changes the format to # sec.
# s—changes the format to # sec.
# sxx
where:
x is other letters—that changes the format to # sec
• The Temporal View and the Case Form printout display the seconds.
• The E2B import and export case functions support seconds and M2 Validation for the
defined fields.

Enter drug information

In this section:
• Product information—field descriptions
• Enter product indications on the drug tab
• Enter Quality Control information
• Enter dosage regimens
• Enter product details
• Enter study drug information

Product information—field descriptions

This section enables you to enter information about the drug being used for the case.

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Table 2-2 Product Information

Field or Control Name Description

Product Name Enter the name of the product using the Select button or by entering a partial
product name. Type a partial product name and press TAB. This displays the
Product Selection dialog box.
If only one product is found, this information is entered without showing the
dialog box. If no match is found in the company product list, the WHO Drug
Dictionary is searched for a possible match through the WHO Drug Dictionary
dialog box. If a match is still not found, the text you initially typed in, is used as
is.
If the study is blinded, the Blinded Name of the clinical study is displayed in
this field. After unblinding, the selected study's Product Name for Unblinded
cases is not shown.
This field supports multiple language entries. Click the multi-language icon to
display the languages window, select the target language from the drop-down
list at the top, and enter the text in the language fields.

Note:
Editing the base entry in English/Japanese is
disabled for product names.

Select Displays the product selection dialog box.

Select a product from the list of company products click Select.
The relevant fields are added to the Case Form.
Encode Click Encode to retrieve the code.
• Suspect Make a selection for the product you are entering. The drug types indicate the
• Concomitant involvement of the product with the adverse event(s) reported for the case.
• Treatment/Other Suspect indicates that the product may have caused the adverse event(s).
Concomitant indicates drugs that are taken with the suspect drug.
Treatment/Other is the drug taken to treat the adverse event.

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Table 2-2 (Cont.) Product Information

Field or Control Name Description

Generic Name Enter the generic name of the drug in a manner similar to the Product Name.
If the study is blinded, the Generic Name is replaced with the Study Name of
the product.

Note:
This name is entered based on the selected
company product.

If the study is blinded, the Blinded Name of the clinical study is displayed in
this field. After unblinding, the selected study's Product Name for Unblinded
cases is not shown.
This field supports multiple language entries. Click the multi-language icon to
display the languages window, select the target language from the drop-down
list at the top, and enter the text in the language fields.

Note:
Editing the base entry in English/Japanese is
disabled for generic names.

Product Identifier Type Auto-populates based on the selected license in the Argus Console >
Studies Configuration > Product > License drop down.
This field is populated only for the new cases being created and on reselecting
the products.
For the existing cases, this field is not updated and remains the same unless a
product is selected again. Not even if configured in Argus Console.
If the selected license does not have Product Identifier Type in Console, then
this field remains blank.
If a License’s Product Identifier Type is changed in Console and saved, the
cases with that license does not reflect the new value unless the product is
reselected.
Product Identifier Auto-populates based on the selected license in the Argus Console >
Studies Configuration > Product > License drop down.
This field is populated only for the new cases being created and on reselecting
the products.
For the existing cases, this field is not updated and remains the same unless a
product is selected again. Not even if configured in Argus Console.
If the selected license does not have Product Identifier in Console, then this
field remains blank.
If a License’s Product Identifier is changed in Console and saved, the cases
with that license does not reflect the new value unless the product is
reselected.
MFDS Product Code Enables you to enter the MFDS product code for the drug.
This field is treated as a blinded field.

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Table 2-2 (Cont.) Product Information

Field or Control Name Description

OTC Product Check this check box if the product administered was an over-the-counter
(OTC) product.
Pre-1938 For non-company products, enter the data.
For company products, this field is updated based on the data available in the
license configuration and is ready-only.
For study products, this field is fetched based on the primary license number
selected in the Console > Studies Configuration.
When unblinded at case level, data is enabled irrespective of the product
selected in the Study Drug drop-down.

Note:
The Pre-1938 field available under the Case
Form > Analysis > MedWatch tab will
not be used in eMDR.

Biosimilar For non-company products, enter the data.

For company products, this field is updated based on the data available in the
license configuration and is ready-only.
For study products, this field is fetched based on the primary license number
selected in the Console > Studies Configuration.
When unblinded at case level, data is enabled irrespective of the product
selected in the Study Drug drop-down.
Compounded Product Check this check box if the product administered was compounded.
Company Drug Code Displays the licensed country for the selected company product.
Obtain Drug Country Country the drug is licensed in.
Drug Code Enter the WHO-DRUG code.
WHO Medicinal Product Displays the Medicinal Product ID associated with the selected WHO drug.
ID For company products, this field is updated based on the data available in
license configuration. If not available, this field is updated based on the data
available in product configuration.
For non-company products, this field is updated based on the selected WHO
Drug.
Formulation Select the formulation of the product. The form in which the drug was
administered (liquid, tablet, capsule, and so on.)

Note:
This field is entered based on the product.
Contact your administrator to adjust this list.

Drug Authorization The country where the drug is licensed.

Country

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Table 2-2 (Cont.) Product Information

Field or Control Name Description

Market Authorization Captures the name of the Marketing Authorization Holder of the product that
Holder was administered.

Note:
For study products, this field is fetched based on
the primary license number selected in the
Console > Business Configuration
> Studies > Product > License
drop-down list.

Authorization Type Captures the Authorization Type of the product that was administered such as
IND, BLA, PLA, and so on.

Note:
The Authorization Type field length was
changed from 5 to 10 characters.
For study products, this field is fetched based on
the primary license number selected in the
Console > Business Configuration
> Studies > Product > License
drop-down list.

Authorization Number Captures the Authorization Number or License Number of the product that was
administered.

Note:
For study products, this field is fetched based on
the primary license number selected in the
Console > Business Configuration
> Studies > Product > License
drop-down list.

Authorized Select a manufacturer name from the manufacture codelist.

Representative
Manufacturer A different Manufacturer can be selected from the drop-down list and can still
be kept as a company product.

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Table 2-2 (Cont.) Product Information

Field or Control Name Description

Concentration Indicates the amount of the drug that was administered.
After a drug and formulation have been entered, select the concentration from
the list, or enter the concentration.
If this information is changed manually, the product is marked as a non-
company product.

Note:
This field is entered based on the chosen
product. The concentration cannot be modified
for a Study drug.

Interaction? Indicates whether the case involves a drug interaction.

Contraindicated? Indicates whether the drug was administered contrary to its indication.
Drug Not Administered Check this check box if no drug was administered on the patient.

Table 2-3 Substance Information

Field or Control Name Description

Substance Name Displays the Ingredient's name.
Strength The Strength of the substance used in the Product.
Unit The drug unit (such as mg, tsp, and so on).
MFDS Ingredient Code Enables you to enter the MFDS ingredient code for the drug.
This field is treated as a blinded field.

Note:
Drug Authorization Country, Authorization Type, Authorization Number, and
Marketing Authorization Holder data are populated from the Argus Console for
company products.
For Study Products, the system populates the Authorization Type, Authorization
Number, and Marketing Authorization Holder data based on the Primary license
number selected in the Argus Console > Studies Configuration. When
unblinded at the case level, Authorization Type and Authorization Number data is not
accessible for users with restricted access to unblinded data.
The application supports printing of the new fields added to the Product Information
tab.

Enter product indications on the drug tab

Enter information about the indicator of the adverse event, like:
• Reported Indication—Reported reaction

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• Coded Indication—Code for the reaction

Both the values could be different or same.

Table 2-4 Product Indication—Field Description

Field/Control Name Description

Reported Indication By default, the value of this field is populated with the Product
Indication from the Product Configuration, if set up. If not, you can enter
a term into the Reported Indication field.

Note:
Oracle Argus Safety automatically
encodes this information. You can also
click Encode to open the coding
dictionary dialog box.

Coded Indication This field is populated with the encoded term when you enter data in
the reported indication field and tabs out.
Encode (Indication) Opens the MedDRA Browser with the term already populated from the
Coded Indication field.
To view the complete MEDDRA hierarchy for the encoded term, click
the Encoding Status icon.
Add Adds a new Indication row.
Only two indications are visible at a time
Delete Click this button to delete the selected Indication row.

Enter Quality Control information

To enter quality control information, click Quality Control.
When you enter information in this section, an action item is automatically created in that case
with text Case Product Product Name sent for QC requires follow up. This
action item is assigned to the you.
If you do not intend to create any action item, then it adds a date in the Product > Quality
Control > QC Result Date field.

You can set the Quality Control section in the minimized form as default, by selecting the
Always minimize Quality Control section on case form common profile switch as Yes.
The Action item code when QC info is entered common profile switch is used to set the
action item code as selected in this switch. If this switch is left blank, then no action item code
is set.

Field Name Description

Quality Control Safety Enter the Quality Control department reference number for the analysis.
Date
Quality Control Cross Enter the Quality Control department reference number for the analysis.
Reference
# CID Number Control Identification Number

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Field Name Description

PCID Number Product Control Identification Number
Lot Number If the Lot Number entered is incorrect, a Lot Number Lookup dialog box is
displayed, that allows you to select from the existing lot numbers.
Quality Control Result Enter the date the result of the analysis was received by the Quality Control
Date department.
Quality Control Result Enter a text explanation as necessary. Use the zoom icon to open the zoom
notes and view or edit the text.

Enter dosage regimens

Field or Control Name Description

Stop Date/Time Enter the stop date and time of the dosage. Entry of time information is
optional, and you can enter partial dates.

Note:
If no Stop Date is entered, Onset from Last
Dose is calculated from the Event Onset Date
and the most recent Stop Date or the most
recent Start Date.

Ongoing Select this checkbox if the drug treatment is ongoing.

The Stop Date, Duration of Regimen, and Last Dose fields are removed if
this checkbox is checked.
Outside Therapeutic Check this checkbox if the drug has not been used in accordance with the
Range label or has been used for outside the Therapeutic Range.
Contact your administrator for further company-specific information on the use
of this field.
Duration of Regimen This value is calculated based on regimen start and stop dates (if full dates are
entered for the start and stop dates). If the value is entered manually, the
duration units (for example: minutes, hours, days, months, or years) must also
be entered along with the actual duration.

Note:
Contact your administrator to set the duration to
be inclusive or exclusive. In Inclusive mode, the
starting day counts in the calculation of the
duration; in Exclusive mode, it does not.

Dose Description This value is entered by using the values from Dose, Dose Units, and
Frequency. If necessary, you can change this value.
If Dose, Units, or Frequency information is changed, this value will be
recalculated.
Daily Dosage This value is calculated based on the dose and frequency. It can be manually
overwritten. If either the dose or the frequency fields are blank, this field is not
calculated automatically.

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Field or Control Name Description

Regimen Dosage This value is calculated based on the daily dose, duration, and frequency. This
total can be overridden. If the daily dose is blank or the frequency fields are 0,
this field is not calculated automatically.
Regimen Dosage Unit This value is derived based on the Daily Dose Units.
Accidental Exposure Select the type of Accidental Exposure from the list. A non-modifiable list of
items is provided for this list.
Pack Units Select the package presentation information of the product.
Contact your administrator to adjust this list.
(New) Tab Click this tab to create a new dosage regimen entry.

Enter product details

Field or Control Name Description

First Dose The earliest regimen start date.
Last Dose The latest regimen stop date.
Duration of Administration Calculated automatically if full dates are available for the first and last
doses.
Total Dosage Calculated based on daily dose and duration.
Time Between First Dose/ The time from the first dose to primary event onset.
Primary Event
Time between Last Dose/ The time from the last dose to primary event onset.
Primary Event
Total Dose to Primary Event The cumulative dose to the time of the event.
Action Taken Select a term.
If you select Dose Increased or No change, the dechallenge and
rechallenge fields are disabled.
Contact your administrator to adjust this list.
Dechallenge Results Indicates the drug stopped for the purpose of determining if it was the
drug that caused the adverse event.
Date Enter the date the dechallenge was carried out.
Gestation Period at Exposure Gestation Period at Exposure is automatically calculated for all
Products in the case by using the formula: Date of First Dose of the
respective Product – LMP Date. It is calculated only if full dates are
available for both fields. If the First Dose occurs before the LMP Date,
then this field is not populated with any data.
Taken Previously / Tolerated Select a response from the list.
Rechallenge Results Make a selection based on whether the drug was taken again.
If Pos or Neg or UNK is selected for the Rechallenge field, the following
fields are enabled:
• Rechallenge Start Date/Time
• Rechallenge Stop Date/Time
• Rechallenge Outcome
Start Date/Time Enter the date and/or time when the rechallenge was started.
Stop Date/Time Enter the date and/or time when the rechallenge was stopped.

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Field or Control Name Description

Specialized Product Category Select specialized FDA product categories such as combination
products, compounded and repackaged products used in eVAERS
reports.
• Abuse Select the corresponding check boxes to provide information on the drug
• Batch and lot tested and populated as Additional Information on Drug [G.k.10.r] in the E2B(R3)
found within reports.
specifications Select the FDA specific additional information on the drug.
• Batch and lot tested and
found not within
specifications
• Counterfeit
• Drug taken beyond expiry
date
• Drug taken by the father
• Medication error
• Misuse
• Occupational exposure
• Off label use
• Overdose
• Tampering
• FDA Additional
Information on Drug
Related Device Comments Enter the details about the devices used with the drug that caused an
adverse reaction.
When entering data entries, only up to 2000 characters are allowed.
Multi-language data entry is supported.
This field is also displayed in the Japanese split-screen of the case form.
A separate data entry field is applicable when using the Japanese
language.

Note:
This field is visible only in the Drug and
Vaccine tab, under the Product tab.

Enter study drug information

You can enter a Study Drug for a Non-Configured Study entered in a case and mark a current
product as a study drug.
To mark a product as a study drug:
1. Right-click any suspect product in the case.
2. To mark the current product as a study drug, select Make Study Drug.
When you mark a product as a study product, then the following changes are observed in the
Product tab:
• The drug type is disabled to make the product a Concomitant or Treatment/Other option.
• Study Drug is a read-only field that contains the product name selected by you.

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You can add a study drug for an unblinded or not blinded study case.
To add a new study drug:
1. Open the unblinded or not blinded study case.
2. On the Product tab, right click any product in the case.
3. Select the Add Study Drug option.

Enter device information

In this section:
• Enter product information
• Enter Quality Control information on the Device tab
• Enter product indications
• Select product delivered by device
• Enter device component information
• Device information—field descriptions

Enter product information

Enter the following information in the Device tab:
M/W Info dialog box
The MW Info dialog box allows you to enter the following device information:
• Is this a single-use device that was reprocessed and reused on a patient?—Indicate
whether the device was labeled for single use. If the question is not relevant to the device
being reported (for example, an X-ray machine), leave the select box cleared.
• Reprocessor Name—Enter information for Address 1, Address 2, City, State, Country,
Postal Code, Fax, and Email Address.
• Select if the device was an Adverse Event or a Product Problem.
• Type of Follow-up Report—Select a checkbox that describes the nature of the follow-up
(supplemental) report:
Correction—Changes to previously submitted information.
Additional information—Information concerning the event that was not provided in the
initial report because it was not known/available when the report was originally submitted.
Response to FDA request—Additional information requested by FDA concerning the
device/event.
Device Evaluation—Evaluation/analysis of the device.
• Device Evaluated by Mfr—Select the Not returned to mfr. checkbox if an evaluation
could not be made because the device was not returned to or made available to the
manufacturer.
Select Yes if an evaluation was made for the suspect medical device. You can attach a
summary of the evaluation and select Yes, Summary Attached.
If an evaluation of a returned suspect or related medical device was not conducted, check
the No checkbox and attach an explanation or provide an appropriate code from the
coding manual (Part II, Subpart A).

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• Reason for Non-Evaluation—Enter the reason for the device not being evaluated by the
manufacturer.
• Other Reason for Non-Evaluation
• If remedial action initiated, check type—Select the applicable actions. If other, specify
the type of action in the space provided (for further reference, see 21 U.S.C. 360h and 21
CFR part 803).
• Usage of Device—Make a selection to indicate whether the use of the suspect medical
device was the initial use, reuse, or unknown.
• USC 360i(f) correction/removal reporting number—Enter the number that the FDA
assigned to the corrective action. If the FDA has not yet assigned a number, the internal
number assigned to the action by the company is used.
• Additional manufacturer narrative—Check the checkbox (if applicable) and enter any
additional information, evaluation, or clarification of data presented in previous sections.
• Corrected Data—Check if the data is corrected.
EU/CA Device dialog box
The EU/CA Device dialog box allows you to enter the device information. Fields are marked by
either an EU flag or a Canadian flag to indicate which entity is mapped to the field.
• Associated Devices—Enter the associated devices with the device.
• Associated Accessories—Enter the associated accessories with the device.
• Firmware version—Enter the firmware version.
• Periodic Summary Report (PSR) ID—Enter the PSR ID, if any.
• Identification of Notified Body involved in Conformity Assessment—Enter
identification number of the Notified Body involved in the conformity assessment procedure
(if any) and the date(s) of the attestation(s).
• Remedial Action by HC Facility—Enter the remedial action taken by the Healthcare
facility.
• Update to Initial Report (Follow-up Report)—Check if the Follow-up report must be
updated to an Initial report.
• Availability of Device—Select whether the device was Destroyed, Returned to
Manufacturer/Importer, or Neither.
• Current location of device—Enter the present location of the device that was involved in
the incident.
• Other—This field is enabled when you select Other in the Current location of the device
drop-down.
• Final Report—Check if this is the final report.
• MIR Report Type—Select the MIR report type as Follow-up Report, Final (Reportable), or
Final (Not Reportable).
• Rationale for Not Reportable—Enter the reason why the considered report is not
reportable. This field is enabled when the MIR Report Type is selected as Final (Not
Reportable).
• Where was the device purchased—Enter the establishment where the device was
purchased.
• Root cause confirmed—Select an option.

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• Risk assessment—Specify if the risk assessment has been reviewed and is adequate.
Select an option as Reviewed and Adequate, Reviewed and Not Adequate, or Not
Reviewed.
• Rationale—Enter the reason for why a review is not required. This field is enabled when
the Risk assessment is selected as Not Reviewed.
• Results of Assessment—Enter the results of assessment.
• Marketed Device Variant/Subset—Enter the value for device variant or subset.
The valid values are:
0 – Model
1 – Software
2 – Other Variant
3 – Lot/Batch
Similar Incidents dialog box
Similar incidents occurring with the same device type or variant of a given manufacturer with
the same investigation finding (IMDRF investigation finding; Annex C) and the same medical
device problem (IMDRF medical device problem; Annex A) have to be reported to National
Competent Authorities (NCA) and European Commission (EC).
Identification and computation of the count of similar incidents is done outside the application.
The application captures the fields for the provided results.
• Similar Incident Device Category—Select the device or device variant used for
identification of the similar incidents.
• Details of the Device Category—Enter the details of the selected device or device
variant.
• Criteria for Number of Devices on the Market—Select the criteria used for the number
of devices in the market.
• Other—This field is enabled only when you select Other in the Criteria for Number of
Devices on the Market field. Describe the criteria.
• Similar Incident Analysis Based on—Select the details based on the similar incident
analysis.
• Rationale—This field is enabled only when you select Other IMDRF Annex or Other
Inhouse Codes in the Similar Incident Analysis Based on drop-down.
• Inhouse Medical Device Problem Code and Term—Enter the most relevant in-house
medical device problem code and term used for identification of similar incidents. This field
is enabled only when you select Inhouse Codes in the Similar Incident Analysis Based
on drop-down.
• Inhouse Evaluation Result/Findings Code and Term—Enter the most relevant in-house
root cause evaluation code and term used for identification of similar incidents. This field is
enabled only when you select Inhouse Codes in the Similar Incident Analysis Based on
drop-down.
• Start Date—Enter the start date for the period for which the analysis of similar incidents is
performed.
• End Date—Enter the end date for the period for which the analysis of similar incidents is
performed.
• No of Similar Incidents in Incident Country—Enter the number of similar incidents
occurred in the incident country.

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• No of devices in Incident Country—Enter the number of devices in the incident country.

• No of Similar Incidents in EEA+CH+TR—Enter the number of similar incidents that
occurred in European Economic Area, (EEA), Switzerland (CH), or Turkey (TR).
• No of devices in EEA+CH+TR—Enter the number of devices in European Economic
Area, (EEA), Switzerland (CH), or Turkey (TR).
• No of Similar Incidents in World—Enter the number of similar incidents that occurred in
world.
• No of devices in World—Enter the number of devices in the world.
• Comments—Enter the comments for identification of similar incidents.

Enter Quality Control information on the Device tab

This section applies to the Quality Control information on the Device tab and to the Quality
Control information on the Drug tab. For more information, see Enter Quality Control
information.

Enter product indications

See Enter product indications.

Select product delivered by device

Field or Control Name Description

Type of Drug Select the type of drug from the drop-down list.
Other Mfg Product Displays the Other Manufacturing Product.
Add Adds another row.
Delete Deletes the highlighted row.

Enter device component information

Field or Control Name Description

Component Name The device component name used in the product.
IMDRF Code Select the IMDRF code for the medical device component via lookup.
Component Term ID The device component term ID of the device component used in the product.
Version The Date or Version of the device component term ID of the device component
used in the product.
Batch Lot # The batch lot number of the device component name used in the product.
Add Adds another row.
Delete Deletes the highlighted row.

Device information—field descriptions

• You can enter up to 10,000 characters in the Additional Manufacturer Narrative field.
Enter the following Product Information in the Device tab:

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Field or Control Name Description

Catalog # Under Catalog#, enter the exact catalog number as it appears in the
manufacturer's catalog, device labeling, or accompanying packaging.
Implant facility Enter the healthcare facility where the device was implanted.
Explant facility Enter the healthcare facility where the device was explanted.
UDI System The UDI System captures the unique identification type of the given device.
The valid values are:
• GS1 – Global Standards 1
• HIBCC - Health Industry Business Communications Council
• ICCBBA - The International Council for Commonality in Blood Banking
Automation
Unique Identifier (UDI) Under Unique Identifier (UDI) #, enter any other applicable identification
# number (for example: component number, product number, part number, bar-
coded product ID).
Data is entered in such a way to handle the UDI Device identifier and UDI
Production Identifier fields.
UDI -DI Enter the UDI device identifier.
UDI-PI Enter the UDI-Product identifier.
Unit of Use UDI-DI Enter the Unit of Use UDI-DI.
Serviced by Third Party Enables you to capture whether the device was serviced by a third party. The
possible values are:
• Yes
• No
• Unknown
FDA Exemption This field is available for the eMDR report and provides a number provided by
Number the FDA. This field enables you to track the approved exemptions or variances
of the adverse event reporting.
Operator of Device Select the type of person operating or using the suspect medical device on the
patient at the time of the event such as Health Care Professional, Patient,
Paramedic and so on.
If Other If the operator of the device is other, enter the operator of the device.
Malfunction Type Make a selection to indicate the type of reportable event. For an event
associated with a malfunction, the FDA refers to applicable sections in 21 CFR
Part 803 reporting guidelines.
Device Outcome The values in this drop-down are derived from the standard Device outcome
codelist.
Device Outcome Detail This field is enabled when the Device Outcome field is set to Other.
Device Comments Allows you to enter details about the device.
Device Available for Indicate whether the device is available for evaluation. Also, indicate whether
Evaluation the device was returned to the manufacturer and if so, the date of the return.
CE Marked Select whether the device is CE Marked or not. This information is preloaded
from License information for a case booked manually, through E2B or LAM,
and can be modified as needed.
Similar Device Check this check box when you report similar devices to FDA. You must report
similar devices when a device causes reportable malfunction and it is likely
that malfunction can occur in similar devices.
Similar devices are identified in a case when this check box is checked along
with the Drug not administered check box being checked and Product Type
set to Treatment/Other.

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Enter the following Malfunction Information in the Device tab:

Field or Control Name Description

Reported Malfunction Enter the malfunction as entered by the reporter.
Determined Malfunction Enter the malfunction as determined by the company.
Listedness Enter the listedness of malfunction in respect of the device.
Reportable Select the reportability of the malfunction.

Enter the remaining fields:

Field or Control Name Description

Patient Problem and This section captures the problem details for a device. It contains the following
Device Problem fields:
Information • FDA Code (for patient problem) (read-only)
• Patient Problem (read-only)
• FDA Code (for device problem)
• IMDRF Code
• Device Problem Term
Patient Problem and related FDA code are read-only fields and code select
option was removed. Any legacy data available can be viewed here.
Use the Device Problem lookup to select the device problem information, like
device problem, FDA code, and IMDRF code.
MedWatch Info In Case Form, the Analysis > MedWatch Info tab only shows the
existing records. This section underwent the following changes:
• The Add and Select buttons were removed.
• The application allows you to delete existing codes, if required.
Evaluation/Investigation To enter the applicable codes from the categories listed, click Select. It
Code Information contains the following fields:
• FDA Code
• IMDRF Code
• Method/Type Term
• Result/Findings Term
• Conclusion Term
Follow the instructions in the dialog box to enter the evaluation codes.
Conclusion codes must be entered even if the device was not evaluated.
Health Impact This section captures the health related information. It contains the following
Information fields:
• Clinical Sign IMDRF Code
• Health Impact Term
Device outcome This field is derived from the standard Device outcome codelist.
Device outcome details This field captures the device outcome details when the Device Outcome field
is set to Other.
Device Comments This field allows to enter details about the device.

EU/CA device dialog box—field descriptions

Field or Control Name Field Length Field Type

NCA Reference Number 100 characters Alphanumeric
Identify to what other NCA's this 2000 characters Alphanumeric
report was also sent

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Field or Control Name Field Length Field Type

Number of Patients Involved 3 characters Numeric
Number of Devices 3 characters Numeric
User facility reference number 21 characters Alphanumeric
Remedial Action by HC Facility 1000 characters Alphanumeric
Usage of Medical Device N/A Checkbox
Other 15 characters Alphanumeric
Update to Initial Report (Follow- N/A Checkbox
up Report)
Final Report N/A Checkbox

When you select the EU/CA Device option, the fields on the Case form are printed. A track of
the fields and any updates are maintained in the audit log.

Enter vaccine information

In this section:
• Enter product details
• Enter prior adverse events information
• Enter product information
• Complete vaccine administration form
• Enter vaccine history

Enter product details

This section is the same for the Product Details section under all the tabs - in the Drugs tab,
Device tab, and the Vaccine tab.
See Enter product details.

Enter prior adverse events information

1. Enter the relevant vaccination information items in the form.
2. Click OK.

Enter product information

Field or Control Name Description

Include in VAERS Block Select the VAERS Form block that this vaccine needs to be printed in.
• Suspect Make a selection for the product you are entering. The drug types indicate the
• Concomitant involvement of the product with the adverse event(s) reported for the case.
• Treatment/Other • Suspect indicates that the product may have caused the adverse
event(s).
• Concomitant indicates drugs that are taken with the suspect drug.
• Treatment/Other is the drug taken to treat the adverse event.

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Field or Control Name Description

Generic Name Enter the generic name of the drug in a manner similar to the Product Name.
if the study is blinded, the Generic Name is replaced with the Study Name of
the product.
This name is entered based on the selected company product.
Formulation Select the formulation of the product. Contact your administrator to adjust this
list.

Note:
This field is entered based on the product.

Drug Authorization Displays the licensed country for the selected company product.
Country
Concentration After a drug and formulation have been entered, select the concentration from
the list, or enter the concentration. If this information is changed manually, the
product is marked as a non-company product.

Note:
This field is entered based on the selected
product. The concentration cannot be modified
for a Study drug.

Units Select a concentration unit.

Contact your administrator to adjust this list.
Interaction? Indicates whether the case involves a drug interaction.
Contraindicated? Indicates whether the drug was administered contrary to its indication. Make
the appropriate selection to indicate whether the drug was contraindicated in
this case.

Complete vaccine administration form

The following are the fields for VAERS Form-1 Use Only:

Field or Control Name Description

Resp. Physician Enter the name of the physician responsible for the patient.
County Enter the county where the patient was vaccinated.
State Enter the state where the patient was vaccinated.
CDC/FDA VAERS # Enter the verification number.
Purchased With Select an item from the list to describe how the vaccine was purchased.

The following are the fields for Vaccine Facility Information

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Field or Control Name Description

Facility Name Enter the name of the facility where the vaccine was administered.
Country Enter the country of the facility where the responsible physician works.
Facility Type Enter the facility type where the patient was vaccinated.
Facility Military Flag Indicates whether or not the vaccination facility was a Military facility.

Enter vaccine history

Field or Control Name Description

Route of Admin Enter the route of administration or a short code for the route of administration.
Contact your administrator to adjust this list.
Anatomical Location Select the anatomical location of the vaccination.
Contact your administrator to adjust this list.
Block 14 If this box is checked, this Vaccine History will be printed in the VAERS Form
Block 14.
Add Adds a new Indication row.

Note:
Only two indications are visible at a time.

Delete Click this button to delete the selected Indication row.

Enter event information

You can enter or view details for adverse events for a case using this tab. It has the following
sub-tabs:
• Events tab
• Event Assessment tab
• Product-Event Details tab
For more information, see:
• Events tab—field descriptions
• Enter data on the Event Information tab
• Enter event coding information
• Enter seriousness criteria
• Enter event assessment information

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Events tab—field descriptions

Field Calculation
Total Dosage The sum of all Total Regimen Dosages.
First Dose to Onset The system calculates this value based on the First Dose Stop date and the
event onset date if present.
If any regimen start date is null, the system sets the First Dose to Onset to
null.
The system uses only complete date entries for the regimen start and stop
date/time fields to calculate First Dose to Onset.
The user can overwrite this field.
Last Dose to Onset The system calculates this value based on the last dose stop date and the
event onset date if present.
If the regimen start date is null, the system sets the Last Dose to Onset is to
null.
The system uses only complete date entries for regimen start and stop date/
time fields to calculate the Last Dose to Onset.
The user can overwrite this field.

• You can change the listedness for a drug at the individual level.
• The field labels for the Event Assessment tab can be updated and configured on the Argus
Console.
• If the Death Seriousness criteria on the Event tab are unchecked, the event outcome
reverts to empty and is not set to fatal.
• The MedDRA LLT term selection behavior across the Case Form is based on the profile
switch value configured in the Allow User to Add Non-Current MedDRA Terms for and
On change of LLT Term Sync English and Japan LLTs, irrespective of the currency.
• The system populates the To be coded value on the MedDRA pop-up window when you
check the green checkbox for the MedDRA hierarchy. This applies to the areas where the
MedDRA dialog box appears.
• The Event to Exclude from Report field enables you to identify information to not include in
a PMDA Expedited report.
– When this checkbox is checked, enter a justification for this action in the Reason to
Exclude from the Report dialog box.
The system places a symbol to the right of the field.
– The system does not retrieve events that are excluded from a report as part of CSPSR
(Clinical Study Periodic Safety Report) unless it has been configured to include them.
When you click the Recalculate button, the system does not recalculate listedness where the
Event Assessment Listedness already has a case justification (generated automatically or
manually overwritten).

Enter data on the Event Information tab

The Event information tab lets you encode adverse events, record criteria for event
seriousness, and display results of automated assessments that determine whether events are
listed in data sheets. It also lists the licenses for the data sheets.
For more information, see:

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• Event information—field descriptions

• Review a diagnosis-event relationship
• Associate a symptom with the diagnosis
• Auto-populate event information
• Configure regulatory reporting rules

Event information—field descriptions

Field or Control Name Description

Relationships Click the Relationships button to view the Diagnosis-Event Relationships
dialog box. This allows you to group symptoms and signs with diagnoses. This
requires at least two events and a diagnosis.
Description as Enter the verbatim term used by the reporter, or patient, to describe the
Reported adverse event. As you type, the term is copied under Description to be
Coded. Verbatim English translations of foreign languages may also be
entered here.
Term Highlighted by Indicate whether the primary source reporting the event considered it a major
Reporter concern. If the information was not explicitly provided, the term is not
considered a highlighted term. The seriousness of the reaction/event must be
based on the ICH E2A criteria.
Selecting Yes does not mark this case as Serious.
Description to be You can modify the verbatim term in this field. For the example:
Coded
The original term can be split, or enhanced with an anatomical
location. Contact your system administrator to prevent manual
encoding of the description. If automatic encoding is enabled,
the term can be auto-encoded to the included term level.

Onset Date/Time Enter the date/time when the event started. Enter a partial date if the full date
is not available.
Onset from Last Dose This field is calculated from the event onset date and most recent stop date
listed in the dosage regimen details of the suspect drug(s). You can also enter
or modify the field manually. This field is removed if the dosage regimen is
ongoing.
Duration This field is calculated from the event start and stop dates. You can also enter
or modify the duration manually.
Onset Latency This field is calculated from the earliest first dose date of the suspect drug(s) to
onset date. You can also enter or modify the duration manually.
Onset Latency = Onset Date - First Dose.
Receipt Date Enter the date on which information about this event was received by your
company. In Flexible Aggregate Reporting, this field is used to filter the events
that fall out of the reporting period.
Patient Has Prior Indicate whether the patient has had a prior history or has suffered from the
History? same event in the past.
Intensity Select the category of severity of the event. Contact your system administrator
to adjust this list.
Frequency Select the frequency of the event from the list. Contact your system
administrator to adjust this list.
Outcome of Event Select the outcome of the event. Contact your system administrator to adjust
this list. If Fatal is selected, Death is selected in the list of seriousness criteria.
If the Death checkbox is subsequently cleared, the outcome still remains fatal.

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Review a diagnosis-event relationship

You can group events in a case, and/or associate them with particular diagnoses. Your
company may determine these or they may be reported to it. This helps in interpreting and
reviewing individual case reports. You can also enable the reporting of diagnoses only while
retaining database records of individual event terms.
Click the Relationships button in the Event Information section to open the Diagnosis-Event
relationship dialog box.
The case must contain at least two events and, at least, one diagnosis. The events related to a
diagnosis are listed on top in this dialog box and the symptoms are indented to the diagnoses.
You can group events together and associate them with individual diagnoses.

Associate a symptom with the diagnosis

Click the up or down arrows to associate a selected symptom with a diagnosis. In Argus
Safety, select the symptom and click Move Up or Move Down.
For the example:
Defining a diagnosis-event relationship can clarify an adverse event report. Suppose an
initial case report describes a patient suffering from Somnolence, Sore Throat, and
Fever.
AE # Diagnosis AE Term (Associated AEs)
1 Somnolence
2 Sore Throat
3 Fever
For reports on all events, they would appear on a CIOMS-I form as:

• Somnolence [SEDATION]
• Sore Throat [SORE THROAT NOS]
• Fever [PYREXIA]
Suppose a Follow-up report then supplies information that the patient also had
neutropenia, and had been diagnosed as suffering from agranulocytosis (the cause of the
sore throat and fever). The somnolence was considered to be coincidental, and unrelated
to any other adverse events.
Neutropenia and agranulocytosis would be entered into the system, and a diagnosis-event
relationship established as follows:

AE # Diagnosis AE Term (Associated AEs)

1 Yes agranulocytosis
2 (sore throat)
3 (fever)
4 (neutropenia)
5 Somnolence

These events would appear on a CIOMS I form as:

• AGRANULOCYTOSIS
• [AGRANULOCYTOSIS] [SORE THROAT],
• [PYREXIA NOS], [NEUTROPENIA]

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• Somnolence [SEDATION]
This immediately provides a clear clinical picture of the case.

Auto-populate event information

The MedDRA application searches the term dictionary for a match at the Lower level or at the
Synonym level. If a match is found, the following fields are automatically populated:
• Term code
• Preferred Term
• Included Term
• High Level Term
• Group Term
• Body System/SOC

Configure regulatory reporting rules

The regulatory reporting rules are mainly configured to look at Seriousness, Listedness,
Causality, and Outcome. Out of these, Listedness and Causality can be captured and
controlled (using the event assessment section) down to an individual license basis.
This granularity allows individual license holders to override the normal listedness and
causality assessment to control the need for submissions to their local regulatory authority.
Each affiliate could either suppress the need for a report by demoting the criteria or add the
requirement for a report by promoting the listedness or causality.
This serves to promote the global reporting automation while maintaining the level of individual
local affiliate control that is often needed.
To obtain an assessment of the adverse event, the product must be in the company's suspect
product and the event must be encoded.

Enter event coding information

The Event Coding section enables you to enter information about the event.

Field or Control Name Description

System Organ Class Displays the body system or System Organ Class. This item is automatically
(SOC) (Code) entered from the event dictionary used and cannot be edited.
High Level Term (Code) Displays the high-level group term when using the MedDRA coding dictionary.
This field is not shown when coding with WHO-ART and cannot be edited.
High Level Term (Code) Displays the High Level Term when the MedDRA coding dictionary is used.
This item is not displayed when event encoding is done using the WHO-ART
dictionary and cannot be edited.
Preferred Term (Code) Displays the preferred term. This item is automatically entered from the event
dictionary used and cannot be edited.
Included Term (Code) Displays the lower level term code. This item is entered from the event
dictionary used and cannot be edited.
Clinical Sign IMDRF Enter the IMDRF code for Clinical Sign via lookup.
Code

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Enter seriousness criteria

Field/Control Name Description
Death Displays the Death Details dialog box

Note:
If you un-check the Death option in the
Seriousness Criteria, you are required to
confirm the deletion of the death details.

Hospitalized Displays the Event Hospitalization dialog box.

Other Check this checkbox to enter explanatory text. You must mandatorily enter text,
specifying the Other Seriousness Criteria.

For more information, see:

• Enter death details
• Enter hospitalization details
• Select nature of event
• Enter event notes

Enter death details

1. Check the Death checkbox under Seriousness Criteria.
The form for Event Death Details appears.
2. Enter information for the items in the form.
3. Click OK to save the entered Death Details.

Note:
When Seriousness criteria Death is unchecked, the system displays a message Do
you wish to delete the Death Details? On confirming, the Death date (NF
or date) and Autopsy details are cleared.

Enter hospitalization details

1. Check the Hospitalized checkbox under Seriousness Criteria.
The form for Hospitalization Details appears.
2. Enter information for the items in the form.
3. Click OK to save the entered Hospitalization Details.

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Select nature of event

The Nature of Event section enables you to identify the nature of the event from the drop-
down list. You can add a maximum of 50 such Nature of Event rows.

Enter event notes

The Details section enables you to enter notes related to the event. If Reported Causality is
entered when the case is booked-in, the system transfers it to this field.

Enter event assessment information

The Event Assessment tab enables you to capture causality and listedness information for a
case. Causality can be captured for both company and non-company products for study cases.
You can enter labeling information in the Event assessment page manually or it can be
determined automatically. Labeling data is entered for all licenses pertaining to company
suspect products against all the events present in the case. In clinical trial cases, labeling
information can be entered for non-company products that are part of Study configuration.
A pre-requisite for auto-labeling is to have active datasheet versions associated with the
Product licenses in the License configuration screen.

Non-clinical trial cases

Labeling is assessed based on the latest datasheet revision and by using the below logic:
• If the event entered in the case is present in the latest datasheet revision, then the
Labeled field is populated.
• If the event entered in the case is not present in the latest datasheet revision, then the
Unlabeled field is populated.
• If the Product license is not configured with a datasheet or associated with a datasheet that
is not activated even once, then the Unknown field is populated for labeling information
and Unspecified is populated for the datasheet name and revision #/name is not
displayed.
• Overall listedness for the datasheet is populated as Listed, Unlisted, and Unknown
based on the labelling information of all licenses within a product.

Clinical trial cases

The Study Configuration screen allows you to set the datasheet revision for licenses
associated with study products.
If datasheet revision is set for the licenses in the Study configuration, then event assessment is
computed based on datasheet revision that is configured or prior datasheet versions, based on
the below logic:
• If the event entered in the case is present in the datasheet revision, then xx configured for
that product license in Study
– If the Onset date is later on equal to the activation date (the datasheet revision that is
configured in Study), then the event assessment is performed using that revision. If
there are multiple datasheet revisions with the same activation date, then the system
takes the most recent revision into consideration.

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– If the Onset date is prior to the activation date, then the system matches the Onset
date of the event with the activation date of the previous revision number, and this
continues until it finds an Onset date later or equal to the activation date. It is not
recommended to have the Onset date set earlier than the activation date of all
revisions, however if this scenario occurs, then the datasheet revision does not get
listed in the event assessment and listedness assessment for that license is displayed
as Unknown.
• If the event entered in the case is not present in the datasheet revision configured in Study
but present in prior version such as xy and if the Onset date of the event is later the
datasheet revision xy’s activation date, then the datasheet revision xy is considered for
listedness evaluation and the Labeled field is populated.
• If the event entered in the case is not present in the datasheet revision xx configured in
Study and its prior versions, then datasheet revision xx is considered for listedness
evaluation and the Unlabeled field is populated.
• Overall listedness for the datasheet is populated as Listed, Unlisted, and Unknown
based on the labelling information of all licenses within a product.
• If there are conflicting listedness within same datasheet for Product, the system displays
the *** symbols for Overall listedness for the datasheet.
The listedness assessment for clinical trial cases is based on the same logic as non-clinical
trial cases in the following situations:
• For non-study products within a Study case;
• Study products for which datasheet revisions are not configured in Study configuration;
• Company study products in non-company clinical trial cases;
• Company products that are part Blinded study and are marked as open labeled products.

Note:
If the Onset date is not specified in the Event section, then the initial received
date is considered. If the Onset date is set at an imprecise date, then the system
considers June as the missing month and 15 as the day for missing day
component and thus matches the Onset date with Activation date and then
performs the event assessment.

When a blinded user (User Information > Protect From Unblinded Information) opens a blinded
case, or opens an unblinded case with blinded study, then the CaseForm > Events >
Event Assessment tab appears as follows:
• License information is blinded.
• Datasheet name is blinded.
• Listedness information is retained as-is.

Assess listedness for blinded clinical cases

When the Include datasheet/licenses for the default blinded study product common
profile switch is selected in Argus Safety Console > System Configuration >
System management > Case Processing > Assessments > Criteria for Event
Level Assessment for Blinded Study, then:
• Event assessment for default blinded product is evaluated.

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– If a primary license is configured in the Study configuration, then the event assessment
is performed for the primary license product.
– If no primary license is configured in the Study configuration, then the event
assessment is performed for any of the blinded product.
• Datasheets and licenses for all the blinded products configured in the Study configuration
against the default blinded case product are displayed in the Case Form > Events >
Events Assessment tab.

Note:
When a blinded study case is created, then a blinded product is added.

– The datasheet name, revision and licenses are displayed for each blinded product
separately against the common blinded case product that is displayed in the first
column.
– The datasheets and licenses are grouped together for each blinded product.
• If any of the blinded product is non-company product, then a single record is displayed as
per the blinded drug to capture listedness.
– For a non-company study product in the Event Assessment tab, the Datasheet column
display Unknown and no link is associated with text displayed.
– For non-company study product in the Event Assessment tab, the License column
display text as (Mkt:) followed by the product name as appeared in the Study
configuration. There is no link associated with the text displayed.
• If the blinded product is the only non-company product or all the blinded products are non-
company products; i.e. none of the blinded product has datasheet/license information, then
a single record is displayed to capture listedness at product/event level.
• If a blinded case created prior to this release is opened with the existing event
assessment, then the Event assessment tab displays the datasheet and licenses for
blinded product evaluated at the time of re-calculation of event assessment. It does not
contain the additional datasheet and license information for all the blinded products from
study configuration against the blinded product.
• Click on Recalculate to perform re-calculation of event assessment. If multiple blinded
products are encountered in the Study configuration, then the Event Assessment tab
displays additional datasheet and license against blinded product including the listedness
evaluation. However, selecting WHO Drug Recalculate in listedness goes back to
Unknown.
• After the case is unblinded and a study product is selected, the event assessment is
recalculated. After unblind, event assessment records for the selected drug are retained
and the event assessment records for non-administered products are deleted from the
case.

Note:
This common profile switch does not impact behavior for the blinded user on the
Products tab.

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All cases
Datasheet revision number/name and activation date is displayed as per the datasheet revision
that was used for listedness computation and it is displayed against each of the licenses
grouped under the datasheet.
Withdrawn date plays a role in listedness determination and this logic is common to both
Clinical and Non-Clinical trial cases.
If a product license has a withdrawn date, then the following logic is applied:
1. If withdrawn date >= initial received date, then the system performs the event assessment
displays the License number and Revision number/name.
2. If initial received date > withdrawn date, then the license does not get listed in event
assessment and its corresponding assessment is not shown.
3. If all licenses within product are withdrawn, then the Datasheet name is shown as
Unknown and Overall Product listedness is displayed as Unknown.
4. If Products has both withdrawn and non-withdrawn licenses and are associated with same
datasheet, then datasheet name associated with Active licenses are displayed and Overall
Product listedness are displayed based on the active licenses instead of Unknown.
5. If Products has both withdrawn and non-withdrawn licenses and are associated with
different datasheet, then the logic specified in c) and d) are used for displaying datasheet
name and Overall listedness is based on active license.
For more information:
• Event assessment tab—user actions
• Filter event assessment details
• Enter product-event details

Event assessment tab—user actions

User Action Result

Click Datasheet The system does the following:
column's + icon • Datasheet revision name and number, along with the activation date that
was used for listedness determination is displayed against the licenses.
• On the License column, all licenses that are associated with the datasheet
are displayed.
• Labelling information that corresponds to the Product licenses is
displayed.
• The License column also displays an icon. You can click the icon to hide
individual product licenses, datasheet revisions and labelling information
and only the overall listedness for the datasheet is displayed.
Click Product Name link You can navigate to Case Form > Products > selected Product.
Click Event Description You can navigate to Case Form > Events > selected Event.
link
Click Datasheet Displays the activation date, revision name, revision number of the latest
Description link datasheet revision on which the listedness assessment was made.
Click Export to get a listing of all labeled terms in an Excel file.
Click Datasheet revision Displays the activation date, revision name, revision number of the latest
number/name link datasheet revision on which the listedness assessment was made.
Click Export to get a listing of all labeled terms in an Excel file.

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Event assessment—field descriptions

Field or Control Name Description

Recalculate Refreshes the Event Assessment section with the newly entered data if new
suspect products or events are entered, or the Event Relationship is modified.
Product Populated when events are entered in the Products tab and appears as:
• First Line - Product Name
• Second Line - Generic Name
Causality as Reported/ Provides the source of causality as reported such as Investigator, Healthcare
Source/ Method/ Result Professional, and so on.
Provides the method used for causality determination.
Provides the result of the causality assessment.
Causality as Provides the source of causality as determined such as Sponsor, MAH, and so
Determined/Source/ on.
Method/ Result Provides the method used for causality determination.
Provides the result of the causality assessment.
Other Causality / Provides the source of causality from any additional source such as NCA.
Source/ Method/ Result Provides the method used for causality determination.
Provides the result of the causality assessment.

Note:
The previous three causality fields can be set up
for:
• Company suspect products in all cases.
• Suspect non-company products in study and
non-study cases.

Event Populated when events are encoded and appears as:

• First Line - Event PT (Verbatim)
• Second Line - LLT
D/S Displays the Diagnosis/Symptom details by D or S.
Seriousness Severity Displays the seriousness, severity, and the duration of the event.
Duration
Listedness Indicates whether the system found the event on the datasheet for this
product.
This field is enabled for company products and non-company study drugs.

Filter event assessment details

Only the assessment rows that match the selected criteria appear in the filtering results.

Field or Control Name Description

Product The Product filter drop-down list contains the All, Company Product(s) and
Non-company Product(s) options. You can filter on all the products which are
present in the Event Assessment dialog box or you can filter on only company
products or only non-company products.
Event Contains a drop-down list of values of distinct Event PT. You can filter on all the
PT(Description)/LLT products which are present in the Event Assessment dialog box.

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Field or Control Name Description

D/S Contains a drop-down list of values of D for Diagnosis or S for Symptoms.
Datasheet Contains a drop-down list of values of distinct Datasheets.

Enter product-event details

The Product-Event Details tab enables you to capture causality information for a case.

Field or Control Name Description

Event Populated when events are encoded and appears as:
• First Line - Event PT (Verbatim)
• Second Line - LLT
Onset from First Dose This date is defined as the earliest regimen start date to Onset and is
completed automatically. The date calculation is based on the Case Form
Calculation for Inclusive or Exclusive.
Onset from Last Dose This date is defined as the latest regimen stop date to Onset and is completed
automatically. The date calculation is based on the Case Form Calculation for
Inclusive or Exclusive.
Total Dose to Event This value is calculated based on daily dose and duration.

Add attachments to your case

The Additional Information tab lets you attach notes and other items to a case. For example,
you could attach a fax message that came in as part of the case and needs to be scanned and
attached or an electronic file received by email. It also lets you set up cross-references to other
cases such as links between cases referring to mothers and children. The total number of
attachments and references attached to a case appears in the header.
• When you click the hyperlink and a reference case is present, the system opens a case
number irrespective of the selected reference type when you clicked the hyperlink.
• If no sites are defined for the attachments classification, the system permits all users to
view the attachments on the Additional Information tab.
• The system permits Workflow Enterprise to view all attachments across all sites.
• You can send different Case Form attachments to different agencies, based on the
Attachment classification specified to the Receiving Agency in the Reporting Destination
Codelist in the Oracle Argus Console. For more information, refer to the Oracle Argus
Safety Administration Guide.
• After the records in Notes and Attachments are sorted, if the following options are
invoked without closing the case, the sort order is respected in these modules:
– Case Form Print
– Medical Review
– Copied Case
For more information, see:
• Enter additional information for the attachments
• Sort attachments

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• Search for Documentum links

• Attach files to a case
• Enter keywords
• Attach references to a case
• View and print attachments

Enter additional information for the attachments

Notes and Attachments- field description

Field or Control Name Description

Notes and Attachments Lets you sort column headers to sort the records based on the fields in the
Notes and Attachment section.
Classification Select a classification that describes the attachment. Contact your system
administrator to adjust this list.
Refer to the Oracle Argus Interchange User's Guide for details about
Attachment Classification usage in sending attachments in electronic reports.
Incl. Reg. Sub Check this checkbox to merge PDF attachments within the Case Form. The
Incl. Reg. checkbox identifies the attachments to be included as an appendix
to Expedited reports. On checking this checkbox, the Expedited reports -
CIOMS I, CIOMS I (Local), US FDA MedWatch 3500 Drug and 3500 A Device
print an appendix page before each attachment. This is added to the case, and
marked as Inc. Reg. Sub checked.
The checkbox is available only if a PDF is selected as an attachment.
Literature Reference Select the Literature that is related to the attachment. Attachments that have
Literature reference are transmitted as inline attachments for the data element
C.4.r.2 in the E2B(R3) report.
Attach File Inserts a file attachment into the case. Maximum file size is 4 GB.
Attach Documentum This option is visible only if Documentum is available.
Link Click Searching for Documentum to search for and attach Documentum.
References Type Select a reference type from the list, for example, a parent-child link. Contact
your system administrator to adjust this list. For description of each reference
type, see Reference Type descriptions.
ID # Enter the case number of the case that is to be referenced.
Click Select to search for the case that is to be referenced. You can also use
this field to record the reference number for external cases.
Select Opens the Case Selection dialog box for the selected ID.

Table 2-5 Reference types and their description

Reference Type Used in Report Description

Parent-Child Link E2B Add the parent-child link between cases.
MHRA Report Number All Add the report number of the submission
made to MHRA.
EMEA Report Number All Add the report number of the submission
made to EMEA.
E2B Report Duplicate E2B Add details of the duplicate E2B report.
E2B GP Medical No. E2B Add the medical number provided by the
specialist.

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Table 2-5 (Cont.) Reference types and their description

Reference Type Used in Report Description

E2B Specialist No. E2B Add the medical number provided by the
general practitioner.
E2B Authority Number E2B Add the Worldwide Unique Case
Identification assigned by the regulator.
E2B Company Number E2B Add the Worldwide Unique Case
Identification assigned by the non-regulator.
E2B Other Number E2B Add the Worldwide Unique Case
Identification assigned by the non-regulator.
E2B Linked Report E2B Add details of the linked report.
HTTP/URL Reference All Add the http or url references as part of the
case.
Patient Link All Use if the multiple cases are reported in the
context of same patients.
MHLW Identical Case Num All Stores case numbers of identical cases
sent to MHLW.
MHLW Registration ID All Stores the Registration ID assigned by
MHLW.
Local Event Number All Add the local event number that was used
to create a case in Oracle Argus Safety.
MHLW Completion Report ID All Stores the Completion ID assigned by
MHLW for the report sent for the case.
DEC ID All
Spanish Local Id All Add the reference number provided by the
Spanish Agency on report submission.
Health Canada File Number All Add the reference number provided by
Health Canada on report submission.
Source Case All Add details of the source case that was
used to create the current case in Oracle
Argus Safety.
PMDA Document Number PMDA Stores details of the documents received
from PMDA.
EUDAMED Reference No. MIR Add the reference number as provided by
EUDAMED.
Historical Ref. All Add details of the historic references
related to the current case in Oracle Argus
Safety.
Other NCA Local Ref. No. MIR Add the local reference number as provided
by NCA.
Other EUDAMED Ref. No. MIR Add the reference number as provided by
EUDAMED.
Other Mfr Ref. No. MIR Add the reference number as provided by
the manufacturer.
NCA local FSCA Ref. No. MIR Add the FSCA reference number as
provided by NCA.
EUDAMED FSCA Ref. No. MIR Add the FSCA reference number as
provided by EUDAMED.
Mfr FSCA Ref. No. MIR Add the FSCA reference number as
provided by the manufacturer.

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Table 2-5 (Cont.) Reference types and their description

Reference Type Used in Report Description

Regulatory Ref. All Add details of the regulatory references
related to the current case in Oracle Argus
Safety.
E2B Hospital Record No. E2B Add the hospital record number.
Companion Case All Add details of the companion case.
MW 3500A Mfr. Rpt. # All Add the report number of the submission
made to FDA in MedWatch format.
BfArM Report Number All Add the report number of the submission
made to BfArM(Germany).
PEI Report Number All Add the report number of the submission
made to PEI(Germany).
Cross Reported IND All Add a reference number of the abbreviated
new drug.
UF/Importer Report # eMDR This is the unique identifier used by the
user facility or the importer for this report.
For a follow-up report, the UF/Importer
report number must be identical to the
number assigned to the initial report.

Sort attachments
Field Description
Keywords On clicking this column header for the first time, records are sorted in the
ascending order (alphabetically) of the Keywords.
Date On clicking this column header for the first time, records are sorted in the
ascending order (chronologically) of the Date.
Description On clicking this column header for the first time, records are sorted in the
ascending order (alphabetically) of the Description.

Search for Documentum links

1. Click the Attach Documentum Link button to open the Documentum Lookup screen.
2. Enter the desired search criteria as per Type Name, Attribute Name and Search String,
and click Search.
3. Select the desired link from the row displaying the search results.
4. Click Select to select the link from the list.

Attach files to a case

1. In the Notes and Attachments section of the Additional Info tab, click Attach File to open
the Attachment dialog box.
2. Click Browse to locate a file attachment.
3. Select the file and click OK.

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Enter keywords
You can associate keywords with a case in the Notes and Attachments section.
To attach keywords to a case:
1. Go to the Notes and Attachments section and click Select.
2. When the system opens the Attachment Keywords dialog box, select a keyword from the
Select a keyword to add to the list drop-down list.
The system displays the selected keywords in the Keywords field.
3. Click OK

Attach references to a case

1. Locate the References section and click Select.
2. When the system opens the Case Search Criteria dialog box, enter the search parameters
and click Search.
3. When the system displays the search results in the Total Number of Rows section, select
the desired search criteria from the list, and click Select to view details about the selected
case.

View and print attachments

The Attachments tab enables you to view and/or print case attachments. The system prints
date/time information:
• As footers on all printouts (except letters).
• In the following format: dd-mmm-yyyy hh24: mm: ss.
To print case attachments:
1. Click the Description link to display the attachment.
2. When the system opens the letter, click Print to print it.

Review local labeling

1. Hover over the Worklist menu and select Local Labeling.
2. When the system opens the Local Labeling screen, select the appropriate information as
necessary.
• Filtering by Product Family: You can filter products in the Event Assessment dialog box
based on the selected product families. Click the magnifying glass icon to filter the search
results by product family.
• The system displays the number of cases currently in view and automatically updates the
range based on the page size specified in the Search dialog box (read-only). For the
example:
If you select 100, the system divides the displayed rows into groups of 100 cases.

• Events assessment can show all listedness values. By default, it shows listedness only for
the core datasheets and countries you have permission to access.

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• Diagnosis - The Diagnosis Filter contains a drop-down list with the following values:
– D (Diagnosis)
– S (Symptoms)
– In the Events Assessment dialog box, you can filter on either the diagnosis or the
symptom.
• By default, the system displays all events with the <ALL> option.
• Datasheets
– The Datasheets drop-down list contains a list of distinct datasheets.
– Displays the revision number and the date on which Datasheet was made active.
– All the blank datasheets display as a single row of Unspecified.
– When you click the Datasheet hyperlink, the system displays the datasheet notes.
• Licenses
– The Licenses drop-down list contains a list of distinct countries for the licenses.
– All licenses not associated with a datasheet appears under Unspecified and are
aligned with the datasheet view.
– When you click the Licenses hyperlink, the system displays the license references.
• The Process button triggers all the applicable rules (both global and local) for the country/
license type for the licenses that are assessed through this screen.
For more information about Local Labeling, see the Oracle Argus Affiliate User's Guide for
Worklist - Local Labeling requirements.

Enable local data entry for Japan

Oracle Argus Safety supports a concept of global lock that indicates the readiness of case data
for global reporting, and a concept of local data locks that indicates the readiness of case data
for local reporting having fulfilled the local data entry and assessment needs.
For more information, see:
• Enable local data entry
• Access local case data lock functionality
• Process an outlier
• Activate local locking in Oracle Argus Safety

Enable local data entry

The application allows local users to open a case for entering local data without globally
unlocking the case and at the same time maintain the integrity of the global case data.
In order to achieve this:
1. The fields in the application are categorized into global and local fields. The local fields
have been identified as local to one or more countries. The local fields for only Japan are
supported in this release.
2. All Oracle Argus Safety Japan users are considered as Japan Local user in this release
and as having access to edit the Japan local fields.

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For more information, see:

• About local fields

About local fields

A field is identified as a Local field to one or more countries based on a new attribute in the
CMN_FIELDS table. The local fields for only Japan are supported in this release.
Customers can configure any field in the Case Form > General, Patient, Products, Events
tabs, and in the Analysis > PMDA tab as a Local field for Japan through back-end updates to
the CMN_FIELDS table.
The Enterprise copy configuration action will copy these updates as per existing functionality.
If a customer configures a field that could update global value as a local field, it is expected
that the customers maintain the integrity of the global data by business SOPs or custom
software processes.
All the fields in a case that is not a Local PRPT case are simply treated as global fields.
All Oracle Argus Safety Japan users are considered as having access to edit the Japan local
fields.
All Japanese text fields, including J User-Defined fields are considered as Local fields for
Japan.
• All Japanese text fields are the fields that currently has separate _J columns.
• All fields from PMDA tab, PMDA Device Information section.
Oracle Argus Safety allows selection of secondary LLT (stored in LLT_J or LLT_CODE_J field)
or Synonym (SYN_CODE_J) encoding using MedDRA J browser that does not change the
base MedDRA hierarchy of English.
The Event Assessment > Listedness field in the tab for the licenses of the local country
corresponding to the local user is considered as a local field. However, this field is available for
editing for the user only when the local user has listedness privilege for that local country
assigned to them via the User Group > Listedness Determination - Countries
access and the datasheet associated with that local country license is configured with "Global /
No Local Assessment Required" checkbox as unchecked.
The Events tab > Infection and Event Exclusion checkbox are also considered as a local field
for Japan.
Any field where an update to a global field can occur is NOT considered as Local field.
All numeric fields, date fields, drop-down fields which share same data value for English and
Japan sides are not considered as Local fields.
However, there are exceptions to this rule where some fields that contain global values are
available for update to local users and in such a scenario, it is expected that the global value
should be protected by customer's business SOPs.
Case classification is such a field that can cause an update to the global value and it is
available as a Local field in the application out-of-the-box.
Study section under General tab requires special handling by the application during local
editing. Study Name, Study Description, Protocol Number, Clinical Compound Number and
Center Name are local fields.

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When the study is a configured study, all these fields are disabled for local editing except
Center Name (J). Center Name (J) is available as an editable local field.
Product Information section in Products tab requires special handling by the application during
local editing. J Drug Code type and the corresponding J Drug Code/OTC Drug Code/
Temporary Code (i.e., DRUG_CODE_TYPE_J, DRUG_CODE_J,), J Generic Name and J
Product Name fields are local fields.
Any field that is already editable after case lock will remain editable even after local lock.
An auto-narrative generation performed during Japan Local data entry (after global lock) only
updates the J field value and does not update the English or any other language field value.

Access local case data lock functionality

This section lists the different sections where the functionality for Local Case Data Lock has
been documented in the Oracle Argus Safety documentation.
Refer to the following table for the list of features and the corresponding guides where they
have been documented:

Local Lock Overview Documented in

Feature
Local Locking and Introduction of new switches: Allow Oracle Argus Safety Administration Guide
Local Unlocking - Local Locking - to allow a local user > 2 Access Management > Configuring
Configuration to be set up with the privilege to Users
locally lock or unlock a case Oracle Argus Safety Administration Guide
Enable Local Unlocking - to provide a > 4 System Configuration > Configuring
system level control permitting local System Management - Common Profile
users to locally unlock a case and Switches
make any corrections to the Oracle Argus Safety User's Guide > Global
previously entered local data. User Management
Changes to the Introduction of action icon - Local Oracle Argus Safety User's Guide > 1
Case Locking Lock - to allow a user to locally lock or Getting Started > Quick Launch Toolbar
Mechanism in unlock a case
Oracle Argus Safety
- Case Form
Changes
Changes to the Allow Global locking and triggering of Oracle Argus Safety User's Guide >
Case Locking global and local reports, and allow Locking a Case
Mechanism in one step global and local locking
Oracle Argus Safety
- Changes to global
locking, One Step
Global and Local
Lock
Changes to the Introduction of new switches: Oracle Argus Safety Administration Guide
Case Locking Allow Forced unlock (Global and > 2 Access Management > Configuring
Mechanism in Local) - to allow users to be set up Users
Oracle Argus Safety with the privilege to forcibly unlock a Oracle Argus Safety Administration Guide
- Changes to Global case that been globally and/or locally > 2 System Configuration > Configuring
Unlocking - locked but pending report generation System Management - Common Profile
Configuration Switches
Allow Global Unlock on Pending
Local Lock - to allow users to be set Oracle Argus Safety User's Guide > Global
up with the privilege to forcibly unlock User Management
a case that is still pending a local lock

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Local Lock Overview Documented in

Feature
Changes to the Control globally unlocking a case Oracle Argus Safety User's Guide >
Case Locking based on local/global reports pending Unlocking a Case
mechanism in generation and /or cases pending
Oracle Argus Safety local lock
- Changes to global
unlocking - Case
Form changes
Case Form changes Configuring Local Reporting Rules Oracle Argus Safety Japan Administration
- Local Reports and Local Reports Guide > 3 System Configuration >
Configuration - Configuring Local Reports - Local
Local Reporting Reporting Rule and Local Reports
Rule and Local
Reports
Triggering Local Changes to report auto-scheduling Oracle Argus Safety User's Guide > Report
Reports - Changes for scheduling local reports Scheduling - Auto-Scheduling
to Report
Scheduling and
Generation
Algorithm - Auto
Scheduling
Triggering Local Changes to report manual scheduling Oracle Argus Safety User's Guide > Report
Reports - Changes for scheduling local reports Scheduling - Manual Scheduling
to Report
Scheduling
Algorithm - Manual
Scheduling
Triggering Local Changes to report generation for Oracle Argus Safety User's Guide >
Reports - Changes generating local reports Triggering Local Reports - Report
to Report Generation Algorithm
Generation
Algorithm
Changes to Changes to DLP while generating Oracle Argus Safety Japan User's Guide >
Expedited Reports local expedited and periodic reports Reports
and Periodic
Reports on DLP

Process an outlier
When a suspect product with a local license is removed on a follow-up, the case remains a
Local PRPT Case (Local Potential Reportable Case) until the corresponding nullification/
downgrade local reports is generated.
If a customer wants to change Local Reports configuration data after being in production with
this release, it is recommended that customers ensure that cases or reports under processing
be completed before changing configuration data to avoid unpredictable results. Note that if a
customer changes the Local Reports configuration data mid-way where the reports are mid-
way processing (e.g., scheduled), the reports will be determined as local or global based on
what type it was at the time when the report was scheduled and will be completed processing
that way irrespective of current configuration even if inconsistent with the configuration. Also,
note that presence of local reports will determine that the case is a local case.
It is also recommended that customers ensure that cases or reports under processing be
completed before up taking the Local Locking feature and (thereby) installing the local lock

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configuration data (refer to Activate local locking in Oracle Argus Safety). Note that if the case
was mid-way processing (e.g., case was open in data entry workflow) when customer up took
the Local Locking feature, a subsequent case save will determine if the case is local or global.

Activate local locking in Oracle Argus Safety

In order to activate the Local Locking feature in Oracle Argus Safety, the installer provides the
users with an option to install the underlying metadata that enables the local lock feature in the
application. A customer, who may not prefer to turn on the local locking feature due to existing
business processes that already handle the local processing needs for a company, could
choose not to install the metadata and thus not uptake the local lock feature in the application.
A separate database script is provided so that the user can run to turn on the Local lock
feature after an upgrade or fresh install. On executing this script, it prompts the user to choose
to turn on the local locking feature and uptake the Local Locking seed data.
The application assumes the default value of 1, parses the user input and installs the Local
Locking seed data for each of the enterprise specified in the comma separated list.
For more information, see:
• Enter local reports configuration seed data
• Enter local users seed data
• Enter local fields seed data

Enter local reports configuration seed data

A new table is seeded to identify Local Reports for Japan:
• Country - The seed data is the country id for Japan (from codelist Countries) for this
release.
• Reporting Destination - The script prompts the customer to provide the default value of
reporting destination for PMDA as below:
Please enter Agency Name for the PMDA reporting destination as configured in the
"Reporting Destination" codelist. This name will be used to identify Local Reports
for all enterprises.

• Report Form - The seed data is the following Japan reports:

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Enter local users seed data

The upgrade installer script prompts the user to choose if all the Oracle Argus Safety Japan
users will be updated to have local locking privileges.

Enter local fields seed data

Note that the CMN_FIELDS are always seeded as part of install/upgrade factory data to
identify the Local Fields for Japan and will be present irrespective of if the customer chooses
local locking feature or not.
In case of multi-tenancy, the customer input value is used to set the seed values across all
enterprises.
This seeding of Local users data is audit logged with the system user.
After install or upgrade, if the customer has turned on the local locking, the icons in the
applicable screens start reflecting the local or global lock status of the case.

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In this chapter:
• Access cases
• Process cases
• Review cases
• FAQs
• What if

Access cases
In this section:
• Search for a case
• Search for a case assigned to you

Search for a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Search Criteria page, enter criteria for your search in any of the following
fields:
• Search For—Select a parameter from the drop-down list and provide a search value
in the adjacent text field.

Tip:
You can select the Pri/Stdy/Othr/Cntr/Rptr/Pat option from the Search For
drop-down to simultaneously search for a value that you specified in the field
adjacent to Search For by all these parameters: Project ID, Study ID, Other
ID, Center ID, Reporter ID, and Patient ID.

• Date Range—Select a parameter from the drop-down list, or enter a custom date
range in the From and To fields, and click OK.

Tip:
Select the Follow-up radio button to search by follow-up dates, including
significant and non-significant event dates.

• Product Family—Select a product category from the drop-down list.

3. To use a new advanced condition query set as criterion for your search, select New from
the Advanced Condition drop-down list or click the AC button. See Create a single filter.

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4. If necessary, check the Full Search checkbox and enter a value in the field adjacent to
Search For to search for cases that contain the specified value in any word order or
combination.
5. Click Search.
6. From the search results list, click a Case ID link.

Search for a case assigned to you

1. On the Home/Personal Argus Status page, check the Cases Assigned checkbox.

Note:
If the Personal Argus Status Page is not your default home page, go to the
Dashboards menu and click Personal Argus Status.

2. From the list of cases assigned to you, click a Case ID link.

Alternately, enter the exact case ID of the case in the Case Quick Launch field, and click
Open.

Process cases
In this section:
• View assigned and unassigned cases
• View the case workload for one or more individuals or sites
• View the workflow status for cases
• Route a case to another workflow state
• Route multiple cases to another workflow state
• Add a follow-up event to a case
• Unblind cases to a study
• Copy a case
• Lock or unlock a case
• Delete a case
• Undelete a case
• Formally close a case
• Print case details for a case
• Print letters and attachments for a case

View assigned and unassigned cases

1. Hover over the Worklist menu, and do one of the following:
• To view unassigned cases and new worklist items that were assigned but not accepted
by users, click New.
• To view cases that were assigned and accepted by users, click Open.

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2. On the New/Open page, enter the required information, and click Search.
3. To select a case by its number, enter a value in the Case Number field.
Alternately, choose a filter from the available filters list.

Note:
Oracle Argus Safety doesn't include open cases that are assigned to you in the
search results.

View the case workload for one or more individuals or sites

1. Hover over the Dashboards menu, and click Case Workload.

Note:
The Case Workload option displays only if you are a Workflow Manager.

2. In the Load Balancing Dashboard section, click the + (plus sign) character next to a
parameter top expand it.
• Week Forecast—Displays the number of cases that Argus Safety estimates for the
selected workflow state or group in the next five days.
• Refresh—Refreshes the number of cases that appear in the Load Balancing
Dashboard every number of minutes you specify.

View the workflow status for cases

1. Hover over the Dashboards menu, and select Worklist Status.
2. Enter search parameters in the search case fields, and click Search.
3. To view cases in a specific workflow state, click a bar graph and perform a select from the
drill-down menu.

Note:
The number of cases displayed changes as cases are updated during case
processing.
Oracle Argus Safety saves your preferences when you return to the Workflow
Status.

4. To apply additional filters, click More Filtering and use the Ctrl + Shift keyboard keys to
make multiple selections.

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Note:
If you don't apply other filters, the Default Report Configuration filter shows
cases for the current month. The cases are evaluated based on their Aware Date
value.

5. To go to a specific worklist screen, double-click the Bar Graph.

Example 3-1 Sample filter options
• Site—Displays active sites except LAM sites in the Argus Code List.
• Workflow State—Displays active workflow states except Archived or Closed in Utilities -
Configuration.

Route a case to another workflow state

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, select the options to use as criteria for your search and click
Search.
3. From the search results list, click a Case ID link.
4. From the Case Form, select the Activities tab.
5. To route the case to the next workflow state, do the following:
a. Select Route.
b. From the Case Routing dialog box, select the state to which to route the case from the
Route to Next State drop-down list.
If there is a single match for the next logical workflow state, then that workflow state is
displayed by default in the Route to Next State drop-down.

Note:
You can view states that are assigned to sites in the Workflow Configuration
only if you are an Enterprise Workflow Manager.

6. To route the case to the previous workflow state, do the following:

a. Click Return.
b. Enter your password in the Case Routing dialog box.
c. Select the user or group the case will be returned to from the Route to User drop-
down list.
7. Enter a routing comment in the Comments field.
Alternately, click Select and choose a pre-defined routing justification from the Select a
standard justification drop-down list.
8. Click OK.
9. In the Case Routing dialog box that opens, click OK.

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Note:
If a case is routed to multiple workflow states or groups, it is counted multiple
times in the Week Forecast.

Route multiple cases to another workflow state

1. You can route multiple cases to another workflow state from:
• Worklist > New
• Worklist > Open
• Case Actions > Open
For Case Actions > Open, you can either select a single case or multiple cases.
2. Select multiple cases and then right-click.
3. Select the Route Multiple Cases option.

Note:
You can select the Route Multiple Cases option only if you have the Workflow
Manager role assigned.

4. If the Enable Checklist on Route option is set in Console > User Configuration,
then the Checklist based on the workflow rule is displayed under the Current State and
Date values.
5. If all selected cases are in the same workflow state, then you can select the next workflow
state from the list displayed in the Route to Next State dropdown. The default value is set
to Current. If there is only one next logical workflow state match, then that workflow state
is displayed by default in the Route to Next State dropdown.
6. In the Route to User dropdown, you can select from a list of users. If there is a single
workflow rule that matches for the next logical workflow state for all selected cases, then
the dropdown will display the user list in accordance to the Group configured in that
workflow rule. If not, all users irrespective of configured groups are displayed.

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7. In the Password field, enter your password. You are required to re-authenticate when the
Require Password on Route option is set in Console > System Configuration >
Workflow > Rules and when you select any matching workflow rule that is displayed
above the dotted line in the Route to Next State dropdown.

Add a follow-up event to a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, select the options to use as criteria for your search and click
Search.
3. From the search results list, click a Case ID link.

4. If the case is locked, unlock the case by clicking the Lock icon ( ) in the Quickstart tool
bar at the top right of the Case Form.
5. From the General Information section, in the Follow-ups sub-section, click the Add button.
6. In the Case Form Operations dialog box, choose if the follow-up event is a significant one
by clicking the Yes or No button.
7. Modify the system date values in the Follow-up Received and Central Received fields as
required for the event.
8. To add a justification for adding the follow-up event to the case, check the Amendment
checkbox.
In the Amendment/Follow-up Justification dialog box, enter a comment and click OK.
9. To add more than one follow-up event to the case, click the Add button again and redo
steps 5 to 7.

Unblind cases to a study

You can perform expedited unblinding (case by case or one case at a time) or unblind cases in
bulk after end of study.

To unblind a case:
1. Hover over the Utilities menu, then Argus Unblinding, and select Unblinding Lite.
2. In the Unblinding Lite dialog box, select a study from the drop-down list.

Note:
The Unblinding Lite dialog box does not include cases that are globally or locally
unlocked, or pending local or global report submission.

3. Select Drug Received from the drop down for the case to be unblinded.
4. To add information on dosage, under the Dosage column, click Select for the
corresponding case ID.
5. In the Dosage Regimens dialog box, click Add and enter the drug dosage information.
6. To display cases that are still in blinded status belonging to the selected study, check the
Display only unbroken cases check box.

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7. Click OK.

To unblind cases in bulk:

Hover over the Utilities menu, then Argus Unblinding, and select Unblinding Advanced.
A list of all the configured EOSU Profiles specific to the user enterprise appears.
For information on creation of new profile and execution of the profile, see the Chapter Argus
Unblinding.

Unblinding Advanced - Fields description

You can sort and search cases based on the following fields.
Field Name Description
Profile Name Displays the profile name.
Study ID Displays the Study ID associated with the
profile.
Last Modified Displays the last modified date and time of
the profile. Time stored in GMT in the
database is reflected in the local user
time-zone on UI.
Last Run Displays the last run date (completed dry-
run or update) of the profile. Time stored in
GMT is reflected in the local user time-
zone on the UI. If the profile was never
executed, the column value remains blank.
Status Displays the latest status of the profile
corresponding to the last run. The screen
refreshes with the latest status only on
reloading the Unblinding Advanced page.
The following are the available statuses:
• Dry-Run In Progress
• Dry-Run Completed
• Dry-Run Failed
• Update In Progress
• Update Completed
• Update Failed
• Not Executed

Copy a case
1. Hover over the Case Actions menu, and click Open.
2. On the Case Search Criteria page, select the options to use as criteria for your search and
click Search.
3. From the search results list, click a Case ID link.
4. Hover over the Case Actions menu and click Copy.
5. On the Case Copy - Webpage page, enter the number of copies to create and click Yes.
6. On the Case Copy page, select the sections from the case to copy.
To copy the entire case, click Select All.
7. Click Copy.

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Note:
Oracle Argus Safety copies any blank values from the case to the case copy.

8. In the Case Routing dialog box:

a. From the Route to Next State drop-down list, select a value to represent the workflow
state for the copied case.
b. From the Route to User drop-down, select a user or user group to return the case to.
c. In the Comments field, add a justification for the copy action.
To add a standard text as justification, click Select, choose the standard text from the
Routing Justification dialog box and then click OK.
d. Click OK.
9. If automatic case numbering is disabled, on the Case Form for the copied case, enter a
case ID.

Lock or unlock a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Search Criteria page, select the options to use as criteria for your search and
click Search.
3. From the search results list, click a Case ID link.
4. From the Case Form, select the Activities tab.
5. From the Case Lock/Close section, click Lock or Unlock.
6. In the Case Locking/Unlocking dialog box, enter your Oracle Argus Safety password in the
Password field.
7. To add a justification for the case lock or unlock, enter data in the Notes field.
8. If you are unlocking a Case Form, click either button to choose the focus page for
significant or non-significant follow-up events:
• Significant F/U—The Follow-up Received Date on the General tab, with the
Significant checkbox checked.
• Non-significant F/U — The Follow-up Received Date on the General tab, with the
Significant checkbox unchecked.
9. Click OK.

Note:

You can also lock and unlock a case by clicking the Lock icon ( ) in the
Quickstart tool bar at the top right of the screen.

Delete a case
1. Hover over the Case Actions menu, and click Open.

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2. On the Case Open page, select the options to use as criteria for your search and click
Search.
3. From the search results list, click a Case ID link.
4. Hover over the Case Actions menu a second time, and click Delete.
5. In the Action Justification dialog box, enter a justification in the Please enter a
justification for performing this action field.
Alternately, click Select and choose a pre-defined justification from the Select a standard
justification drop-down list.
6. Enter your password in the Password field.
7. Click OK.

Note:
Once you delete a case, users can no longer access it from the Oracle Argus Safety
application.

Undelete a case
1. Hover over the Utilities menu, and select Case Undelete.
2. On the Case Undelete page, enter search values in the fields from the Case Search
Criteria section and click Search.
3. Check the checkbox for the case number to restore and click Undelete.
4. In the Action Justification dialog, enter a justification in the Please enter a justification for
performing this action field.
Alternately, click Select and choose a pre-defined justification from the Select a standard
justification drop-down list.
5. Click OK.

Formally close a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Search Criteria page, select the options to use as criteria for your search and
click Search.
3. From the search results list, click a Case ID link.
4. From the Case Form, select the Activities tab.
5. From the Case Lock/Close section, click Close.
6. Enter your password in the Case Closure dialog box.
7. Click OK.

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Note:
Formally closing a case isn't the same as closing the Case Form for the case and
returning to the previous page.
To modify the details of a formally closed case, you must first re-open it by providing
your password.
You don't need to unlock a locked close case before you close it.

Print case details for a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the search results list, click a Case ID link.
4. Hover over the Case Actions menu, and click Print.
To print the Case Form for the case:
a. Select Case Form.
b. From the Print Case dialog box, check the checkbox for each section to print or check
the Select All checkbox.
c. If you don't want the print to include product information for the case, check the Blind
Study Product checkbox.
d. Click Print.
To print the Medical Summary for the case:
a. Click Print Medical Summary.
b. From the medical summary report, select File and then Print.

Print letters and attachments for a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the Case Form for the case, select the Additional Information tab.

4. Click the Print Case icon ( ) at the top of the page.

5. In the Print Case dialog box, select the tab corresponding to the item type to print (Letters
or Attachments).
6. Click the Description link for a letter, or the Classification link for an attachment to view
the item in Adobe Acrobat.
7. Click the Print File icon at the bottom.

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Note:
Letters are the only Oracle Argus Safety printouts that don't include date/time
information in the footer section.

Review cases
For more information, see:
• View correspondence contacts for a case
• Generate a letter on a case
• Track correspondence for a case
• View case action items
• View revisions for a case
• View the audit log for a case
• View the coding status of a case
• Perform a medical review of a case
• Perform a coding review of a case
• Perform a regulatory submission review of a case

View correspondence contacts for a case

1. Hover over the Worklist menu, and select Contacts.
2. On the Contacts page, enter case information in the fields as necessary.
3. From the results list, click a Case ID link for which to view correspondence contacts.

Generate a letter on a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Selection page, enter the search criteria for a case and click Search.
3. From the results list, select a case.
4. From the Case Form for the case, click the Activities tab.
5. In the Contact Log section, click New Letter.
6. From the Custom Letter Templates dialog box, select a letter template and click OK.
7. From the Save Letter dialog box, click Yes and modify the application generated letter as
appropriate.
Alternately, click No to save the Oracle Argus generated letter as is.
8. In the Attach Letter for Case dialog box, click Browse and navigate to the location of the
saved letter.

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Tip:
You can then modify the value in the Date Sent field in the Contact Log to
schedule an action item for the letter.

The following table describes the meaning/status of various letter icons.

Icon Status
Scheduled letter is awaiting to be sent

Letter is overdue (Date Open > System Date)

Indicates email success status

Click this button to open a message editor

Track correspondence for a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the results list, select a case.
4. From the Case Form for the case, click the Activities tab and select Contact Log.

View case action items

1. On the Home or Personal Argus Status page:
• To view your pending action items, check the Action Item Entries checkbox.
• To view action items for a specific case, click a case number link and then select the
Activities tab.
You can view the details in the Action Items section.
2. From the Worklist menu, select Action Items.
• To view details for a specific case action item, enter search criteria in the relevant
fields:
– S/U/R—Select the case-level assessment values for the case that contains the
action items as Serious, Unlisted, Related.
– Action Item Code—Select the case action item code.

Note:
You can modify the Description value that the application uses for the
selected action item code as required.

– Action Item Category—Allows you to filter the action items. Select a value from
the dropdown list. This dropdown lists values based on the selected Action Item
Code for which action item category is configured in the Action Category code list.

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• Check the checkbox corresponding to the type of case action item to view:
– To view only case action items with due dates before the current date, check the
Overdue Action Items checkbox.
– To view only query-type case action items, check the View Query Action Items
checkbox.

View revisions for a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the search results list, right-click a Case ID link and select Case Details.
Alternately, open the case and select Case Revisions from the Case Actions menu.
4. From the Case Details dialog box, click the plus sign (+) next to Revisions.
5. Click the Revision History text to view all the revisions for the case in the Audit Log
Details dialog box.
6. Click an entry under Revision History.

Tip:
For descriptions of the icons associated with the revisions, see What are the lock
states for a case?

7. From the Audit Log Details dialog box, to view details for a specific revision in read-only
mode, select the revision from the revisions list.

Tip:
You can also view revisions for a case by selecting Case Revisions from the Case
Actions menu.

View the audit log for a case

1. Hover over the Utilities menu, and select Logs.
2. Select View Audit Log.
3. Enter or select search criteria for the log in the Search Conditions section and then click
Search.

4. Click the Action item icon ( ) for a case.

5. In the Audit Log Details dialog box, to view details for revisions made on the case on
specific date, select the date entry at the bottom of the dialog.
Alternately, check the checkbox next to the Revisions Date column to view a listing of
revisions made on the case through all the dates.

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Note:
Audit log is done for case data only that can be viewed from Case Revisions > View
Audit log > Category > Cases. Audit log of reports is not covered in case revisions or
case audit log data.

View the coding status of a case

1. Hover over the Worklist menu, and select Coding Status.
2. On the Coding Status page, enter case search criteria.

Note:
To filter cases by an advanced condition, click Advanced. Select the advanced
condition and click OK.

3. Note the coding status icon for the case.

For a description of the icons associated with the coding status, see What does the coding
status icon indicate for a case?

Perform a medical review of a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Selection page, enter the search criteria for a case and click Search.
3. From the results list, select a case.
4. Hover over the Case Actions menu and click Medical Review.
5. In the Medical Review - Case Form dialog box, to add a narrative to the case:
Manually fill in the Narrative text box.

Tip:
To enter the narrative in a specific language, click the icon representing the
language above the text area.

Alternatively, to fill in the Narrative text box with text from an auto narrative template, click
Generate.
a. In the Custom Auto Narrative Templates dialog box, select a template from the list of
available templates and click Append. To replace the selected template with a new
auto generated narrative template, click Replace instead.

b. To add information in addition to the narrative, click the Case Comment icon ( ).
c. If the case has events that are encoded using the MedDRA dictionary, select either D
for Diagnosis or S for Syndrome from the D/S field.

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d. To switch to data sheet view and display the License column, click the + (plus) icon for
Datasheet.
Revision number and date on which the Datasheet was made active are also
displayed.
6. To view a read-only version of the case, click the Temporal View tab.
a. Filter the data categories to appear in the Event Assessment section by checking the
corresponding checkboxes in the Display Options section.
b. To view details for an event listed in the Event Assessment section, click the Info icon
for the event.
c. Enter information about any relevant tests performed in the Relevant Tests field in the
associated section.
7. To attach notes and other items to the case, or to create cross-references to other cases,
click the Action Items/Addl Info tab.

Perform a coding review of a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Selection page, enter the search criteria for a case and click Search.
3. From the results list, select a case.
4. Hover over the Case Actions menu and click Coding Review.
5. Click Product Information and review the existing information about the case.
6. To change information about the case:
a. If the product is not a predefined company product, select a value from the
Formulation list.
b. Enter a value for the indication as reported in the Reported Indication field.
c. Enter the indication to be coded in the Coded Indication LLT field.
d. To display the associated coding dictionary, click Encode.
7. Click Action Items and review the existing action items for the case.
To add an additional action item for the case:
a. Enter the date an action item was created for the case in the Date Open field.
b. Select an action item code from the Code list.
c. Select a group to be responsible for the action item from Group/Responsibility.
d. Enter the date on which the action item must be completed in the Due field.
To mark an existing action item for the case as completed, enter the completion date in the
Completed field.

Perform a regulatory submission review of a case

1. Hover over the Case Actions menu, and click Open.
2. On the Case Open page, enter the search criteria for a case and click Search.
3. From the search results list, click a Case ID link.
4. From the Case Form, select the Analysis tab.

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5. To view differences in narratives for the case, in the Case Analysis section, click Show
Difference.

Note:
The Show Difference button is enabled only if at least one previously locked
version exists for the case.

6. To create a MedWatch 3500A Drug Report, select the MedWatch Info subtab.
a. Enter the following details in block B:
• If the product caused an adverse event in a patient, in Block B, select Adverse
Event.
• If a product defect or malfunction lead to the death or serious injury of a patient,
select Product Problem.
• If a malfunction or problem of the product caused the death or serious injury of a
patient, select both Adverse Event and Product Problem.
b. In block C, enter medication data in Suspect Medications.
c. Enter the following information in block G:
• Match all report sources in Reporter Type by checking the corresponding Report
Source check boxes.

Note:
If the country of incidence isn't the US, the value Foreign appears by
default.
If the primary reported on the General tab is a health care professional,
the value Health Professional appears by default.

• Alternately, select Other and enter the necessary text.

• Enter the PLA number in STN# Pre-1938/OTC Product.
- If the product pre-dates 1938, select Pre-1938.
- If the product is an over-the-counter product, select OTC product.
7. To review information about the history and the current condition of the patient and
generate the BfArM 643 form, select the BfArM Info subtab.

Note:
If available, Oracle Argus Safety uses the relevant information from the Current
Medical Status Form on the Patient tab to fill in the fields on the BfArM Info tab.

a. Enter a causality or modify the existing value from the Causality drop-down list.
b. Select or modify the existing values that apply to the patient from the drop-down lists in
the Check One in Each Category section.
8. To assess imputability for the suspect product, select the AFSSAPS Info subtab.

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a. Check one or more check boxes in AFSSaPS Information.

Tip:
Check the Autres check box to enable the corresponding field.

b. Enter a description in Future Actions.

FAQs
• What is a case owner?
• Can I reassign a case to another owner?
• When does a case become open?
• How do I create a query-type action item for a case?
• What happens to a query-type action item after its due date has passed?
• How can I view a summary of all the open cases?
• How can I view a summary of cases with open action items?
• When can I formally close a case?
• What happens to a study if I unblind the cases that are associated with it?
• How can I track which case revision contains significant follow-up information for the case?
• How can I interpret the differences between two narratives for a case?
• What other case details can I retrieve from the Routing Comments log?
• Can I view the original case from a copied case?
• What are the lock states for a case?
• Can I apply a local lock on a case that already has a local lock for another country?
• If I am an Oracle Argus Safety Japan user, can I enter local data, copy or modify a case
that has a global lock?
• If I am an Oracle Argus Safety Japan user, can I apply both a local and a global lock on a
Local PRPT case that I entered?
• Can I change the outcome of a case as part of my medical review for the case?
• Can I change the causality for a case during my medical review?
• What do the case assessment values stand for?
• Who is the MDR contact person?
• How does Oracle Argus Safety set the Receipt Date for a case?
• How does Oracle Argus Safety set the Aware Date for a case?
• How does Oracle Argus Safety set the Date Received value for a case?
• Which actions can I perform on a saved letter?
• Can I edit or remove a letter after it was sent for a case?
• If I change the Date Sent value for a letter, must I also change the Due Date for the action
item associated with the letter?

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• Where can I view action items for letters?

• Why do only some action items for a case appear as Sent in Letter?
• Can I auto-generate a letter for a case?
• Which actions can I do on an auto-generated letter?
• What does the coding status icon indicate for a case?
• Why does a border appear for a coding action item for a case?
• Why is there a green dot in the Notes area of a case summary?
• Why do only some user names appear in bold in the Case Workload?
• Why does the (SUSAR case icon) icon appear as the lock state icon for a case?
• Why do some letter icons from the Contact Log have an exclamation mark?
• Why does an asterisk (*) symbol appear next to the username for some users in the Case
Routing dialog?
• How to attach multiple files to a single letter for follow ups?

What is a case owner?

A case owner is the first user to accept a case after book-in. This user has the right to assign
the case to another user.

Can I reassign a case to another owner?

Yes, you can reassign a case to another user if you are a Workflow Manager and the initial
owner of the case.

When does a case become open?

Oracle Argus Safety assigns the Open state to a case when the user accepts their assignment
to the case.

How do I create a query-type action item for a case?

Based on the advanced conditions rules for the query-type action item, Oracle Argus Safety
generates an open query-type action item when you save a case or when you click the
Generate Query icon on the Quick Launch toolbar for a case.
The Due Date for the query-type action item is the System Date plus the Due Date (in days) as
defined in the codelist. Similarly, the Open Date is the system date on the day the Query was
created for the case.

What happens to a query-type action item after its due date has passed?
Once the due date for a query-type action item has passed, Oracle Argus Safety:
• Closes the query-type action item, if it doesn't meet the criteria of the Advanced Conditions
for the case.
• Attempts to resolve the open query-type action item in the Case Form without creating a
new action item with the same name.

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How can I view a summary of all the open cases?

To view a summary of all the open cases in PDF format, hover over the Dashboards menu and
select Open Case Summary. Cases in the summary are sorted in ascending order as per the
number of days each case has been open.

How can I view a summary of cases with open action items?

To view a summary of cases with open action items in PDF format, on your Personal Argus
Status page, hover over the Dashboards menu and select Open Action Items.

When can I formally close a case?

You can formally close a case only if the following conditions are met:
• You have access rights to the case.
• Action items for the case are complete.
• Expedited regulatory reports for the case are submitted.
• Expected follow-up information for the case was received.
• The case isn't locked.
Closing a case is the final stage of the case workflow. After a case is closed, Oracle Argus
Safety archives it.

What happens to a study if I unblind the cases that are associated with it?
If you unblind cases that are associated with a study that is complete and single or double
blinded, Oracle Argus Safety sets the Blinding Status value of each case to Broken After
Study.

How can I track which case revision contains significant follow-up

information for the case?
Oracle Argus Safety uses the following designations for items in the Audit Log Details dialog
box:
• (S) F/U— Significant follow-up information was attached to the case.
• (NS) F/U—Non-significant follow-up information was attached to the case.
Users can mark follow-up information as significant or non-significant on the General
Information tab of the Case Form for the case.
Each company can use its own definition of what significant follow-up information represents.

How can I interpret the differences between two narratives for a case?
Oracle Argus Safety uses the following conventions to signal the differences between two
narratives on the Show Difference page:
• Strikethrough red text with yellow highlight—Narrative text that was removed.
• Regular text with green highlight—Narrative text that was added.

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What other case details can I retrieve from the Routing Comments log?
In addition to user justifications for case routing, the Routing Comments log also includes
details of any lock or unlock action that a user did on the case, even if that user was a system
user such as the AG Service.
Note that the log displays only one entry if a global/local lock or a global/local unlock is applied
at the same time to the case.

Can I view the original case from a copied case?

Yes, to view the original case, open the case form, and select the Additional Information tab for
the copied case. The original case appears highlighted in the References section.

What are the lock states for a case?

Oracle Argus Safety uses the following states for a locked case:

• Local Locked ( )— The case requires follow-up. Any user who tries to access the case
will be required to either view it as read-only, or unlock of the case at the local level.

• Local Unlocked ( )— The case is available to other local users.

• Global Locked ( )— The case requires local reporting.

• Global Unlocked ( )— The case doesn't require local or global reporting.

• Global Locked and Local Locked ( )— The case is a Local PRPT case and is locked
at both local and global levels for all local countries for the case.

• Global Locked and Pending Local Lock ( )— The case is a Local PRPT case and is
locked at global level but pending a local lock for any local country for the case.

Can I apply a local lock on a case that already has a local lock for another
country?
Yes. You can apply a local lock on case that already has a local lock only if:
• Enable Local Unlocking is set to Yes for your tenant.
• There are no local reports pending for the case in the country for which the initial local lock
was applied.

If I am an Oracle Argus Safety Japan user, can I enter local data, copy or
modify a case that has a global lock?
Yes, you can enter local data, copy, or modify a case that has a local lock. However, you can't
change the Classification value or generate local reports for the case.

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If I am an Oracle Argus Safety Japan user, can I apply both a local and a
global lock on a Local PRPT case that I entered?
Yes, you can apply both a local and a global lock on a Local PRPT case in one step if you
select the Perform Local lock additionally for a Local PRPT case option in the Case
Locking dialog box.
If this option isn't available, contact your Administrator to set the value for Enable Local
Unlocking to Yes for your tenant.

Can I change the outcome of a case as part of my medical review for the
case?
Yes, you can change the value of the Case Outcome field based on your medical review for
the case.
Oracle Argus Safety sets an initial value of the Case Outcome field based on the outcome
values of events from the Events tab of the case.
Note that changing the outcome for the case doesn't change the outcome value for any of the
events for the case.

Can I change the causality for a case during my medical review?

Yes, if values already exist in the Causality as Reported and Causality as Determined fields on
the Medical Review page, you can change them during your medical review.
• Oracle Argus Safety automatically adds the text that was added to Reported Causality
when the case was booked in. You can select a different value for Causality as Reported,
respectively override the text in Causality as Determined if you have the necessary
access rights.
• Your Administrator is responsible for maintaining the list of available causalities for a case
and for defining which causalities can be reported.

What do the case assessment values stand for?

Oracle Argus Safety uses the following assessments values for a case:
• S—Serious
• U—Unlisted
• R—Causality
• A—Unknown
• F—Fatal
• LT—Life Threatening
• H—Hospitalized

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Who is the MDR contact person?

The Medical Device Reporting (MDR) contact person is the designated contact for the device
user facility or distributor and the person the FDA conducts MDR correspondence with. This
individual may not be an employee of the facility.

How does Oracle Argus Safety set the Receipt Date for a case?
Oracle Argus Safety sets the value of the Receipt Date field based on the state of the Display
Initial Receipt Date always option.
• When the Display Initial Receipt Date always option is enabled, and there is follow-up
information for the case, Oracle Argus Safety uses the value from the Initial Received Date
field.
• When the Display Initial Receipt Date always option is disabled and follow-up
information exists for the case, Oracle Argus Safety uses the value of the latest Follow-up
Received Date regardless of the significance of the information.

How does Oracle Argus Safety set the Aware Date for a case?
If follow-up information exists for a case, Oracle Argus Safety uses the value of the latest
significant follow-up information as the Aware Date for the case.
If follow-up information doesn't exist for a case, Oracle Argus Safety uses the value of the
Initial Receipt Date field as the Aware Date for the case.

How does Oracle Argus Safety set the Date Received value for a case?
The Date Received value is the latest Follow-up Date value for the case.
• If there are multiple Follow-up Date values, then the Date Received value is the oldest
Follow-up Date value that exists for the case.
• If there is no Follow-up Date value for the case, then the Date Received value is the initial
Receipt Date value for the case.

Which actions can I perform on a saved letter?

You can view saved letters in the Uploaded letters folder.
You can edit a saved letter by clicking the corresponding email button in the Contact Log and
then editing it in the message editor.

Can I edit or remove a letter after it was sent for a case?

After a letter is sent, you can no longer edit it. You can only remove it manually.

If I change the Date Sent value for a letter, must I also change the Due Date
for the action item associated with the letter?
No. Unless the action item that is associated with the letter has already been completed, when
you change the Date Sent value for the letter, Oracle Argus Safety also updates:

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• The Due Date for the associated action item, to match the new Date Sent value.
• The number of days for the action item that is specified in the letter configuration.

Where can I view action items for letters?

You can view action items for letters for a case in the Action Items section on the Case Form
for the case. You can view action items for letters across cases on the Action Items page from
your personal worklist.

Why do only some action items for a case appear as Sent in Letter?
Action items that appear as Sent in Letter are query-type action items for the case.

Can I auto-generate a letter for a case?

No. For Oracle Argus Safety to auto-generate a letter after you save a case, contact your
system administrator.
Based on settings, Oracle Argus Safety can:
• Auto-generate a letter after a specific number of days since an adverse event is reported
for a case.
• Auto-generate a follow-up action item for you to follow up with a correspondent after the
letter is sent.
Auto-generated letters are sent to the first correspondence contact by default.

Which actions can I do on an auto-generated letter?

You can view auto-generated letters in the Contact Log section of the Case Form for a case.
You can view or print an auto-generated letter by double clicking the letter icon in the Contact
Log section and selecting the associated action from the Letter Preview dialog.

What does the coding status icon indicate for a case?

The coding status icon indicates the state of the term to be coded for a case.

• Red cross mark ( )—The term was coded.

• Green check mark ( )—The term was successfully coded.

• Grey hourglass ( )—Oracle Argus Safety submitted the term to Central Coding, but
didn't yet receive a result.

• Red stop sign ( )—Oracle Argus Safety submitted the term to Central Coding but
received an error either from Central Coding or from Argus.

Why does a border appear for a coding action item for a case?
A red border indicates that the respective action item was completed for the case. Oppositely,
a green border indicates that the respective action item wasn't completed for the case.

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What if

Why is there a green dot in the Notes area of a case summary?

The green dot that appears in the Notes area is an option for the related field. You can click
the dot to revert to the initial automatic value for the field, or view previous overriding notes.

Why do only some user names appear in bold in the Case Workload?
User names that appear in bold in the Case Workload are online users who can view the
Online Help icon.

Why does the ( ) icon appear as the lock state icon for a case?
The ( ) icon denotes that the case is a Suspected Unexpected Serious Adverse Reaction
(SUSAR) case.

Why do some letter icons from the Contact Log have an exclamation mark?
Letter icons that have a green exclamation mark indicate letters that were successfully sent.
Letter icons that have a red exclamation mark indicate letters that are overdue.

Why does an asterisk (*) symbol appear next to the username for some
users in the Case Routing dialog?
The asterisk (*) symbol next to a username denotes that the user who entered the routing
justification for a case has since received the Disabled status in Oracle Argus Safety.

How to attach multiple files to a single letter for follow ups?

1. In the RPT_TRANSMIT_EMAIL_ATTACH table, insert records from backend with the same
ID as in the RPT_TRANSMIT_EMAIL.ID column created for the letter.
2. Configure letter from Argus Console > Code Lists > Argus > Letter
Configuration.
3. Go to Case Form > Activities > Contact Log > New Letter.
4. Select Configured Letter, and save.
5. Click Email Letter, enter the required email address in the To field, and send.

What if
• The Medical Review page appears empty for a Case Form
• The narrative text for a case contains blank spaces or placeholders
• I can't change the assessed seriousness of a case
• I can't change the determined listedness of a case
• I can't select the language I need for my text narrative?

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What if

The Medical Review page appears empty for a Case Form

The fields on the Medical Review page are user-defined. To view them, you must first enable
the desired fields from Analysis page in the Case Form. The system saves the selection as a
default and uses it when you open the Medical Review page for other case.

The narrative text for a case contains blank spaces or placeholders

Blank spaces or placeholders can appear when the narrative text for a case is auto-generated.
Oracle Argus Safety displays blank spaces for placeholders that are missing data, and actual
placeholders if the placeholders are incorrect.
Contact your Administrator to amend the template for the auto-generated narrative text, or to
enable auto-generated narrative text to be modified.

I can't change the assessed seriousness of a case

If any Seriousness Criteria was selected for any Event on the Event page for the case, Oracle
Argus Safety automatically sets the value of Case Serious to Yes. To override this value,
contact your Administrator to receive access rights.

I can't change the determined listedness of a case

Oracle Argus Safety automatically sets the value of the Listedness Determination field based
on the value of entries from the Event Assessment section on the Events tab of the case.
• If any of the entries appear as 'unlisted', the value of Listedness Determination is unlisted.
• If all the entries appear as listed, the value of Listedness Determination is listed.
• If all the entries have an unknown value, the value of Listedness Determination is
unknown.
• In all other cases, the value of Listedness Determination is blank.
To override this value, contact your Administrator to receive access rights.

I can't select the language I need for my text narrative?

If the icon representing the language you need to enter narrative in does not appear for your
case, contact your Administrator to set up the respective language in the application.

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Filter cases with advanced conditions
In this chapter:
• Create a single filter
• Create a set of related filters
• Share filters with other users
• Modify a filter
• Use filters to view the case series list
• Export the case series list to a spreadsheet
• Import a case series list from the spreadsheet and save
• Find filters
• Access filters from the Advanced Condition Library
• FAQs
• What if

Create a single filter

1. From the Case Actions drop-down menu, select Open.
2. In the Case Search Criteria section, from the Advanced Condition drop-down list, select
New.
You are asked to confirm whether you want to create a query set (a set of filters).
3. To create a new single filter, in the Confirmation dialog box, click No.
4. Enter Name and Description of the new filter.
5. Select the types of values for the filter:
• To include values from the codelist, select From Code List.
• To include values from the case data, select From Case Data.
6. From the Properties navigation tree, select a field name or item to use as a filter.
7. From the Conditions list, select a relational operator to establish a relation between the
field name and the value.
8. Repeat from step 5 to step 7, until all the filters are added.
Use the logical operators (AND and OR) to control whether all the selection criteria must
be met for the case to be retrieved or that any one of the conditions must be met.
9. Click Save.
10. Click Yes if you want to share the filter with other users.

See also, Share filters with other users.

11. Click OK.

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Create a set of related filters

Create a set of related filters

1. From the Case Actions drop-down menu, select Open.
2. In the Case Search Criteria section, from the Advanced Condition drop-down list, select
New.
You a asked to confirm whether you want to create a query set (a set of filters).
3. To create a set of filters by linking a previously defined filter, in the Confirmation dialog box,
click Yes.
4. To add a filter, click Add.
5. When the new row appears in the filter selection area, do one of the following:

• To add an existing filter, click the Lookup icon ( ), click Filter, from the search
result select a filter, and click OK.
• To enter a new filter criteria, click AC, and follow the procedure to Create a single filter.
6. From the Set Operator list, select an operator to link your filters.
This set operator links this filter to the next filter.
7. Repeat from step 4 to step 6, until all the filters are added.
8. Enter the Name and Description of the new filter.
9. Click Save.

Share filters with other users

Sharing filters with other users is possible only if access of the User group is defined in Argus
Console through Access Management.
1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.
3. To find a filter, from the drop-down list, select an option.
• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and click AC.
6. In the Advanced Condition Set dialog box, check the Share with other users checkbox.
7. Click OK.

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Modify a filter

Tip:

• If a filter is not shared with other users, the filter does not appear in the list for
any user except the Administrator and the user who created it.
• If the filter is shared, all users in the system can view the filter, but cannot
modify it.
• You cannot stop sharing a filter, if the filter is in use in the system.

Modify a filter
1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.
3. To find a filter, from the drop-down list, select an option.
• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and click AC.
6. Update the filters, and click Save.

Note:
To save the changes as a new filter, click Save As.

Use filters to view the case series list

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.
3. To find a filter, from the drop-down list, select an option.
• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and click OK.
6. On the Case Open page, click Search.

Export the case series list to a spreadsheet

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.

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Import a case series list from the spreadsheet and save

3. To find a filter, from the drop-down list, select an option.

• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and click AC.
6. In the Advanced Condition Set dialog box, go to Case Series tab.
7. To list the cases that match the filter, click Find Now.
8. Select the cases from the list.
9. To save the list, click Store Case Series.

Note:
You must save the list before exporting.

10. Click Export to export the cases in CSV format.

Import a case series list from the spreadsheet and save

1. From the Case Actions drop-down menu, click Open.

2. Click the Lookup icon ( ) next to the Advanced Condition drop-down list.
3. To find a filter, from the drop-down list, select an option.
• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and click AC.
6. In the Advanced Condition Set dialog box, go to Case Series tab.
7. Click Import.
8. Enter the description to import the cases and click OK.
9. Browse the file to be imported and click OK.
10. Click Store Case Series to save it for later use.

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Find filters

Tips:

• You can import an XLS, XLSX or TXT file with one column containing case
numbers.
• When you upload a text file, each line in the file is considered a complete
case number.
• If a case is missing (cannot be found) or has been deleted, a message
appears.
• If the same case has been entered multiple times; only one entry is retained
for the same and rest are ignored after the import process is complete.
• For case series, the import process, imports 1000 cases/60 seconds.

Find filters
1. From the Case Actions drop-down menu, click Open.

2. To open the Advanced Condition Lookup dialog box, click the Lookup icon ( ) next to
the Advanced Condition drop-down list.
3. To find a filter, from the drop-down list, select an option.
• Contains—Search the filters that contain the entered criteria.
• Starts With—Search all the filters that start with the entered criteria.
4. In the text box, enter the search criteria, and click Filter.
5. From the search result, select a filter, and do one of the following:
• To list the selected filters in the Advanced Condition drop-down list, click OK.
• To view the details for the selected filter in the Advanced Condition dialog box, click
AC.
• To close the Advanced Condition Lookup dialog box without saving changes, click
Cancel.

Access filters from the Advanced Condition Library

1. From the Utilities drop-down menu, select Advanced Condition Library.
2. From the list of filters, select a filter, and from bottom-right of the page, click an option:
• To create a filter, click New, and do one of the following:
– Create a single filter (skip step 1 and step 2).
– Create a set of related filters (skip step 1 and step 2).
• To modify an exiting filter, click Modify.
See also, Modify a filter (skip step 1 and step 2).
• To delete a filter, click Delete.
• To print a list of filters, select the filters, and click Print List.
To print the entire list of filters, check the checkbox from the heading, and click Print
List.

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FAQs

3. To find filters for a specific time period:

a. From the Date Range drop-down list, select an option. Or, enter date range in the
From and To fields.
b. From the View options, select Advanced Condition.
c. Click Search.

FAQs
• What is an advanced condition?
• What is an advanced condition query set?
• How do the logical operators work?
• How do the set operators work?
• What is a case series (formerly Hit list)?

What is an advanced condition?

An advance condition is a filter that can be a complex or non-standard query where that uses
field-level data or dictionary terms as criteria to search cases. These queries act as filters to
search for cases.

What is an advanced condition query set?

An advanced condition query set comprises two or more filters combined to create a more
complex filter. These query set act as filter to search for cases.

How do the logical operators work?

You can use the AND and OR logical operators to set the conditions of when the filter is used.
• The AND operator returns only those cases that match both the conditions in a filter. No
case is found if one of the condition match in the filter.
• The OR operator returns cases that match either or both the conditions in a filter. No case
is found if none of the condition match in the filter.

How do the set operators work?

You can use the UNION, INTERSECT, and MINUS set operators to combine multiple
conditions in a filter.
• The UNION operator returns cases found in either filter.
• The INTERSECT operator returns only those cases that are found in each filter.
• The MINUS operator returns cases that are found in either of the filters, but not in both
filters.

What is a case series (formerly Hit list)?

A case series is the search result of a filter or set of filters. See also:

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What if

• Export the case series list to a spreadsheet

• Import a case series list from the spreadsheet and save

What if
• I am unable to find a filter
• I am unable to view cases that match the filter criteria
• I am unable to view values of a codelist
• While adding a value to a property, the Select button is disabled

I am unable to find a filter

You may not have the access rights to use the filters. Only users with execute rights for a filter
can view the filters in the drop-down list.
If you do have the access rights, you can find your filters either by using the Lookup icon
( ) (see Find filters) or from the Advanced Condition Library (see Access filters from the
Advanced Condition Library).

I am unable to view cases that match the filter criteria

When using a set of filters to search cases, the search result is also dependent on the values
entered for Date Range fields and the Initial/Follow-up selection. Therefore, if a case is not part
of the Date Range for the filter, the case does not display when you click Search.

I am unable to view values of a codelist

The values in the Code List are configured by the administrator in Argus Console. To configure
these values, refer to the Oracle Argus Safety Administration Guide.

While adding a value to a property, the Select button is disabled

The Select button is enabled only for a property whose value is a term that can be coded.
• For MedDRA related terms, the MedDRA browser appears.
• For other terms, the Product browser appears.

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Code an adverse event term
In this chapter:
• Autocode a term
• Manually code a term
• FAQs
• What if

Autocode a term
1. Open a case.
2. Select Events.
3. In the Event Information section, under Description as Reported, enter the term to code
exactly as it was reported and then press the Alt+Tab keys on your keyboard.
The coding details for your term appear in the Event Coding section.
If autocoding did not succeed in finding a coding for your term, see Manually code a term.
4. To print the selected coding as a PDF report:
a. Press Encode.
b. Select the coded LLT term.
c. Press Print.

Manually code a term

1. Open a case.
2. Select Events.
3. In the Event Information section, under Description as Reported, enter the term to code
exactly as it was reported and then press the Alt+Tab keys on your keyboard.
If autocoding did not find a coding for your term, the MedDRA Browser dialog box opens.
4. In the MedDRA browser dialog box, perform the following:
a. In the LLT field, refine the description of your search term using a wildcard character
(%), an alternative term, or a company-specific synonym that matches your term, and
then press the Alt+Tab keys on your keyboard.

Tip:
To view a specific LLT, click the LLT entry.

b. To print the selected coding as a PDF report, press Print.

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FAQs

c. To accept the current LLT selection as the coding for your term, double-click the LLT
selection or press Select.
The coding details for your term appear in the Event Coding section.

FAQs
• Which dictionaries does Argus Safety support?
• What is the MedDRA browser?
• What are the five levels of the MedDRA dictionary?
• What is a synonym?
• What is autocoding?
• What happens if you don't enable autocoding?
• What are Standard MedDRA Queries (SMQs)?
• What is a full search?
• What is a non-current term?
• How can I view details for a coded term?
• How can I narrow my search in the MedDRA browser?
• Why does a dictionary coding appear highlighted in yellow in the MedDRA browser?
• Why can't I use the Export button to export a coding?
• What is Null Flavor data?

Which dictionaries does Argus Safety support?

Oracle Argus Safety supports MedDRA, MedDRA J, WHO Drug Global and Chinese, and J
Drug dictionaries. The application maintains a single version of each dictionary in the
database.
In multi-tenant environments, each tenant can have its own versions of each dictionary. The J
Drug dictionary is the only dictionary version that is common to all the tenants.

What is the MedDRA browser?

The MedDRA (Medical Dictionary for Regulatory Activities) browser is a utility that you can use
to code a term such as a disease, sign, or a symptom with an internationally standardized
medical term. This is a way to ensure consistent drug terminology in the Oracle Argus Safety
application.
The MedDRA browser appears when you create an Advanced Condition (also known as a
filter) or when you enter case details in the Adverse Event Form. You can also access the
MedDRA browser from the Utilities menu.

What are the five levels of the MedDRA dictionary?

The MedDRA dictionary hierarchy is a categorization of medical terminology. The five levels of
the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level
Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

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FAQs

The lower the level of the dictionary, the more precise the medical terminology becomes.
Preferred Terms (PTs) represent medical terms you can use as the end result for coding.
For the example:
If the term to code is "queasy," the preferred equivalent medical term (PT) is "Nausea"
in the context of the following hierarchy:
System Organ Class (SOC) = Gastrointestinal disorders
High Level Group Term (HLGT) = Gastrointestinal signs and symptoms
High Level Term (HLT) = Nausea and vomiting symptoms
Preferred Term (PT) = Nausea
Lowest Level Term (LLT) = Feeling queasy

What is a synonym?
A synonym is a term or a combination of terms that nearly or exactly match the meaning of the
term to code. Each organization defines its own list of synonyms for coding. To add a term to
the list of synonyms, contact an Administrator.

What is autocoding?
Autocoding is an Oracle Argus Safety feature that Administrators can enable for terms to be
automatically coded using the MedDRA dictionary. If autocoding is not enabled in the Oracle
Argus Safety application, or if autocoding does not find a match for your term in the MedDRA
dictionary, you must manually search and select a coding for your term in the MedDRA
browser.

What happens if you don't enable autocoding?

If autocoding is not enabled in Oracle Argus Safety, you must manually search and select a
coding for your term in the MedDRA browser.

What are Standard MedDRA Queries (SMQs)?

Standard MedDRA Queries are predefined sets of MedDRA terms that you can use to retrieve
codings in the MedDRA browser. SMQs are developed and validated by the CIOMS Working
Group and are updated for each MedDRA dictionary version.

What is a full search?

When you run a full search, the MedDRA browser retrieves terms that contain your search
term in any word order and combination. Alternatively, MedDRA retrieves only terms that start
with your search term.

What is a non-current term?

A non-current term is a term that you can no longer use for coding, but is retained in the Oracle
Argus Safety database for historical data retrieval. A coding term can become non-current if it
is vague, ambiguous, outdated, truncated, misspelled, or derived from a terminology that is
incompatible with MedDRA.
Non-current terms appear next to an asterisk symbol (*) at the LLT level in the MedDRA coding
browser and in the search results list.

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What if

How can I view details for a coded term?

To view details for a coded term such as the dictionary version it was coded against, or SOC,
HLGT, HLT, PT, LLT level values, click the green check mark next to Event Coding on the
Case Details or new Advanced Condition form.

How can I narrow my search in the MedDRA browser?

To narrow your search for a coding, you can use one of the following options in the MedDRA
browser:
• To search for the term in a specific Standard MedDRA Queries (SMQs) category, select
the category from the MedDRA SMQ drop-down list. To search for the term across all
dictionary levels, enter the term in Search All Levels and press the Enter key on your
keyboard.To search for the term against any combination of terms that includes your term,
check Full Search.To search for the term also against codings that may not be included in
the selected dictionary version, click Include Non-current terms.

Why does a dictionary coding appear highlighted in yellow in the MedDRA

browser?
A yellow highlighted coding in the MedDRA browser represents the primary System Organ
Class (SOC) path for a term with more than one path or SOC.

Why can't I use the Export button to export a coding?

The Export functionality is reserved for Administrators.

What is Null Flavor data?

Null Flavors are used to describe the reason for missing data. ICH E2B(R3) and regional
agencies such as CBER, EMA, MFDS, and PMDA have published guidelines on the allowed
Null Flavors for various fields that are part of the E2B(R3) report. A Null Flavor set is a
collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors
in the Flexible Re-categorization Codelist.
Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor
button ( ) next to the fields. On clicking the button, a drop-down list appears and allows
you to select Null Flavor data as configured in the Field Properties Configuration in the Argus
Console. The background color of the NF button changes (from grey to blue) when a Null
Flavor is selected from the drop-down list.
When the Case Form field has data and the user clicks the button, the system displays a
warning message that data will be cleared on switching to the Null Flavor field. The data is
cleared or retained based on user confirmation. When data pertaining to the field is received,
Null Flavor data can be overwritten by actual data by clicking the NF button.

What if
• Autocoding is not enabled in my application
• Autocoding is unsuccessful

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What if

• I receive a "No Records Found" message when I manually code a term

• The coding I previously used for a term now features an asterisk and can no longer be
selected in the MedDRA browser, as it is labeled as non-current

Autocoding is not enabled in my application

If your Administrator did not enable autocoding in the application, you must manually search
and select a coding for your term in the MedDRA browser.

Autocoding is unsuccessful
If your Administrator enabled autocoding, but autocoding did not find a coding from the
MedDRA dictionary for your term, the MedDRA Browser dialog box appears on the screen for
you to manually search and select a coding for your term.
To attempt autocoding a second time, refine the description of your search term in the LLT field
using a wildcard character (%), an alternative term, or a company-specific synonym that
matches your term.
The application populates the fields in the Event Coding section with the details of a MedDRA
coding match.

I receive a "No Records Found" message when I manually code a term

If you received a No Records Found message when manually coding your term in the
MedDRA browser, you can refine the description of your search term in the LLT field using a
wildcard character (%), an alternative term, or a company-specific synonym that matches your
term.

The coding I previously used for a term now features an asterisk and can no
longer be selected in the MedDRA browser, as it is labeled as non-current
If one of your active cases contains an adverse event term that has been coded with a term
that now appears next to an asterisk symbol (*), you must code the term a second time for the
respective case, or ask an Administrator to recode the term for you using the MedDRA
recoding tool.

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Manage your Expedited Report submissions
This chapter lists tasks related to preparing, submitting and tracking compliance for Expedited
Reports (ICSRs - Individual Case Safety Reports).
For more information, see:
• Schedule an Expedited Report
• Submit your Expedited Reports
• Track your Expedited Report submissions
• Manage your Incoming ICSRs
• FAQs

Schedule an Expedited Report

In this section:
• Schedule a report manually
• Auto-schedule a report
• Create unscheduled Expedited Reports or batch print reports
• Review a draft Expedited Report
• Review your scheduled reports
• View Expedited Report status

Schedule a report manually

1. Open the case for which the report has to be scheduled.
2. When the system displays the Case Form for the selected case, select Regulatory
Reports, and then select Schedule New Reports.
3. When the system opens the Schedule New Expedited Report dialog box, enter the
appropriate information in the fields in the dialog box:

Field Description
Aware Date If an Aware Date is appended with '(A)' in the drop-down list, it is used to
denote the aware date of an Amendment.
The resulting expedited report Due Date is based on the selected Aware
Date and the duration of the Due Date section.
The selected Aware Date has no impact on the Actual Due Date if the user
specifies an absolute Due Date. For instance, selecting a date in the Due
Date field causes the report to be due on the specified date, regardless of
the selected Aware Date.
This drop-down list is only populated and enabled after a license has been
selected. The Aware Dates are displayed in descending order of the
Current Aware Date.

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Schedule an Expedited Report

Field Description
Protect Confidentiality If this check box is checked, the patient's name and address will not appear
of Patient and on any of the regulatory reports, and the patient information will show the
Reporter word PRIVACY.
For non-US cases, the application also displays MSK null flavor in the
eVAERS report when this check box is checked. MSK is populated only
when the data element contains some data and is not null.

4. Click OK.
To view all scheduled reports, go to Reports, then select Compliance, and click Expedited.
Alternatively, you can go to Worklist, and select Reports.

Auto-schedule a report
1. Open the case for which the report has to be scheduled.
2. Select Regulatory Reports, then select Auto Schedule or Auto Schedule Device.
Reports will be scheduled against the reporting rules which have been set up by the
administrators.

Create unscheduled Expedited Reports or batch print reports

You can use the Batch Reports function to schedule and generate reports for multiple cases.
Before using this function, verify that no cases or reports are open.
1. Select Reports, then select Compliance, and select Expedited.
2. Click Batch Print or Create Report and search for the case for which the expedited report
has to be scheduled.

Table 6-1 Expedited Reports - Fields and Fields Description

Field Description
Suspect Product Displays the Trade Name for which the report has been scheduled. A (+)
displayed at the end of the Product Name denotes that more than one
Suspect Company Product exists.
For Reports which were scheduled for the Device, the Device name gets
displayed.
F / LT Denotes Fatal / Life Threatening
If the case is both F and LT, only F is displayed.
If the case is neither F nor LT, No is displayed.
7/15 Displays 7 if the report is due within 7 days.
Displays 15 if the report is due in more than 7 days.

3. When the system displays the search results, select the locked cases for which the
expedited report is to be scheduled.
4. Click Batch.
5. When the system opens the Batch Print or Create Reports dialog box, enter the
appropriate information and click OK.
The system generates the unscheduled expedited report. The Expedited Batch Printing dialog
box supports printing Batch CIOMS, Medwatch, and VAERS on Oracle Argus Safety Web
locally.

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Schedule an Expedited Report

Note:
The Batch print or create Reports for E2B reports is supported for locked cases
only. These reports are generated as only final report with Run at option enabled,
and Save with case, mark as submitted checkbox as checked and disabled
(default) for E2B reports.

Table 6-2 Batch Print or Create Reports dialog box—Fields and Field Description

Field Description
Format Enables you to print reports As Draft or As Final.
• The Print As Final option is available only if all the selected cases are
locked.
• If Print As Final is selected, then the option Save with case, mark as
submitted is also available as a checkbox option.
• Click the options Print As Final and Save with case, mark as submitted
to generate final Regulatory Reports and create a submission record with
each case identical to the current functionality.
• Click the options combination of Print As Final only (and not Save with
case, mark as submitted) to generate final Regulatory Reports without
creating a submission record with each case.
• If the report is associated with a blinded study, select the Blind study
product checkbox.
Destination Check the Printer checkbox to print the report.
Protect Confidentiality Check this checkbox to hide the Reporter and Patient information on the
of Reporter and Patient expedited reports.
Scheduling • If Run Now is selected, all the selected reports run against all selected
cases and a PDF is generated.
The Run Now option is visible only when a MedWatch, MedWatch Drug,
CIOMS, or VAERS form is selected on the Batch Expedited Report
screen.
If you select an unlocked case, the report gets printed in draft form only
and is not saved.
• Select Run at and enter the appropriate date and time when the
generation of reports should occur.
Due Date You can select parameters for the report due date calculation. This option is
available for final reports with the Save with case, mark as Submitted
checkbox set.

Review a draft Expedited Report

1. Open the case for which you want to view a draft report.
2. Click the Regulatory Reports tab.
3. From the Total Number of Rows tab, locate the relevant report and click Draft to view the
report.
4. Alternatively, click the Draft Report icon on the top right of the screen.
a. From the View Draft pop-up, select the Report Form, Destination, and Product.
The Report Form drop-down displays the list of expedited reports and the Destination
drop-down displays the list of reporting destinations configured in Console. Based on
the report form and destination, the products are displayed as explained below:

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• For the Drug Report Forms, the left most suspect product with the drug license
that matches the agency country is displayed as default.
• For the Device Report Forms, the left most suspect product with the device license
that matches the agency country is displayed as default.
• For the Vaccine Report Forms, then left most suspect product with the vaccine
license that matches the agency country is displayed as default.
When no product with license matches to the license type and agency country in
the case, then the primary suspect product is displayed, that is left most suspect
product in the Product tab.
• For the Drug Report Forms, the drug license with earliest award date of the
selected product that matches the agency country is used to generate reports.
• For the Device Report Forms, the device license with earliest award date of the
selected product that matches the agency country is used to generate reports.
• For the Vaccine Report Forms, the vaccine license with earliest award date of the
selected product that matches the agency country is used to generate reports.
b. Click OK.
The report is generated in the draft mode.

Review your scheduled reports

The Regulatory Reports tab enables you to view all scheduled reports.
When a new case is created, there are no reports associated with it. As data is entered and the
case is saved, the regulatory report scheduling algorithm determines which reports, if any, are
required for that case.
The reports determined to be necessary appear in the Regulatory Reports tab. You can
manually schedule reports through the Reports menu or by clicking the Regulatory Reports
tab. You can also add comments to existing reports. The comment section can be updated to
enter notes for a report even after it has been submitted.
• The case submission date must be on or after the initial receipt date for the case. If the
submission date is before the initial receipt date, the system displays an error message.
• The system displays the time component for the date generated on the Case Form >
Regulatory Reports tab using the IE offset of the client machine for the display.
• The system displays the time component for the date generated on the Report Details
using the IE offset of the client machine for the display.
• When you manually schedule an Expedited report, the system places the word, Manual, in
the Notes field along with the current notes information.
When a case is opened in read-only mode, the application enables you to view the final report
whether generated, approved, or submitted.
For more information, see:
• Review a list of your scheduled reports
• View your scheduled reports

Review a list of your scheduled reports

• Go to Reports, then select Compliance, and then select Expedited Reports.

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You can print draft expedited reports from the Batch Print or Create Reports without printing
DRAFT on the reports from the Case Open or the Reports | Compliance | Expedited Reports
dialog box.

View your scheduled reports

• To view scheduled reports, hover over the Worklist menu and select Reports.
When the system opens the Reports screen, enter the appropriate information as necessary.
Report filter options
• The search results appear in the Report Details dialog box and permit the user to enter the
approval notes that are applied to all selected reports. The system skips any reports
selected by the user that have the following statuses:
– Scheduled
– Disapproved
– Approved
• The system hides the reports fields from the report details dialog box and does not permit
the user to access or modify any other tabs.
• The system hides the Route button to prevent users from modifying the Report Status.

Option Description
Reporting Destination Displays the report destination (agency) for which the report is scheduled.
Report Status Displays the status of the report as Approved, Generated or Scheduled.
Report Form Displays the description of the report.
Filtering Reports You can click the respective magnifying glass icons to filter reports based on
Destination, Product Family, and Country of Incidence. The system displays
the standard lookup dialog box.
By Destination The Report Destination filter multi-selection screen list contains the names of
all agencies as configured in the Oracle Argus Safety Regulatory Authority
CodeList.
By Product Family The Product Family filter multi-selection screen contains a list of all product
family names as configured in the Oracle Argus Safety Products codelist.
By Country of The Country of Incidence filter multi-selection screen contains a list of all
Incidence available countries.

View filter results

The Total Number of Rows section displays the result based on the selected filter criteria with
following details:

Field Description
Selected Allows the user to select one or more reports, on which actions can be
performed.
Suspect Product Displays the trade name for which the report has been scheduled. A "+"
displayed at the end of a Product Name indicates that more than one Suspect
Company Products exist.
A Device Name is also displayed for those reports which were scheduled for
the Device.
Diagnosis Displays the Primary Event Diagnosis PT.

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Field Description
Event Verbatim Displays the event verbatim (verbatim as reported) of the Primary Event.
F or LT Indicates whether a case is fatal or life threatening as follows:
• F identifies a Fatal (F) case
• LT identifies a Life Threatening (LT)
If any of the above are present together, then Fatal takes precedence followed
by LT. If the case is neither of the above, No is displayed.
7/15 Displays 7 if the report is due within 7 days.
Displays 15 if the report is due in more than 7 days.
Report Form Displays the description of the report.
Click the link to view the DRAFT report PDF.
Initial / Follow-up (#) Displays if the report is Initial or Follow-up.
If it is a Follow-up, the follow-up number is printed.
Downgrade Displays Yes if the report is a Downgrade report.
View Report Enables the user to view the report as a PDF.
Local Labeling Enables the user to view the local labeling dialog box.
• This option is available only if the user has access to Local Labeling within
the groups to which the user belongs to.
• The Local Labeling can also be viewed by clicking the local labeling icon
that is displayed next to S/U/R.

View Expedited Report status

1. To review the status of expedited reports, select Dashboards, and then select Expedited
Report Status.
2. In the Search Case section, enter the parameters, and click Retrieve.
3. To view a list of cases, click the relevant section of the pie chart or bar chart.

Note:
When you have access to Expedited Report Status, you also have access to the
Report Due Soon dashboard.

Submit your Expedited Reports

In this section:
• Generate an Expedited Report
• Approve your report
• Transmit an ICSR
• Transmit several ICSRs at once
• Print your reports
• Store Expedited Reports in Documentum

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Generate an Expedited Report

You can generate a report using either of the following procedures.
Method 1: Generating a report
1. Verify that the relevant case has been locked and the required report has been scheduled.
2. Open the selected case to display its associated Case Form.
3. Open the report from the Regulatory Reports tab of the Case Form.
4. When the system opens the Regulatory Reports details for the selected case, locate the
relevant report and click the Final link to generate the report.
Method 2: Generating a report
1. Verify that the relevant case has been locked and the required report has been scheduled.
2. Select Case Actions, and then click Open to view the Case Open form.
3. Click Search to view cases matching the search criteria.
4. When the system displays the search results, click the Lock State icon and select Case
Details.
5. When the system opens the Argus Safety Case Details dialog box, open the Scheduled
Regulatory Reports folder and select the relevant regulatory report.

Note:

• You do not need to lock the case to preview a report in draft mode.
• If you have access rights to view or print blinded information, you are prompted
to select whether you would like to view a blinded or unblinded version of the
report. If your access rights disallow you from viewing or printing unblinded
information, you can view only a blinded version of the expedited report. The
following items are not displayed when viewing a blinded version of the expedited
report:
– Clinical Treatment Given (Study Drug field)
– Study Drug Formulation and Concentration
– Study Drug Dose, Daily Dose and Route
– Study Drug Batch/Lot # and Expiration Date
• If the case is locked you can generate the report from the Worklist >
Reports, Reports > Bulk Reporting, and Reports > Compliance >
Expedited screens.

Approve your report

1. Open the case associated with the report that needs to be approved.
2. When the system opens the Case Form, click the Regulatory Reports tab to displays the
case details.

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3. Click the icon associated with the report you wish to approve and select View Report
Details.
4. When the system opens the Report Details dialog box, click the Routing tab.
5. When the system opens the Routing tab, select Approved from the State drop-down list
and click Route.
6. When the system opens a dialog box, enter the required information and click OK to
approve the report.

Transmit an ICSR
To transmit reports one by one, select Reports Detail Dialog, and click the Transmit tab.
• Go to Case Actions, then click Open, and select Regulatory Reports. Left-click on the
Status icon, and select Transmit.
• Go to Report, then select Compliance, and select Expedited. Left-click on the globe icon
to show the report details, and select Transmit.
The Transmit tab enables you to transmit a case electronically.
1. Select the recipient from the Available Recipients list.
2. Select the transmission method from the Method list.
3. Enter any comments under Comments.
4. Click Transmit.

Transmit several ICSRs at once

To transmit several reports at a time, go to Reports and select Bulk Reporting, then select
Print Regulatory Report and click Transmit. Select the cases you wish to transmit, and click
Transmit at the bottom of the screen.
The Bulk Transmit function lists the status for all transmission events against your assigned
cases.
To view the Bulk Transmit page, hover over the Worklist menu and select Bulk Transmit.
For more information, see:
• Filter reports
• User options
• View routing details

Filter reports
The Total Number of Rows section displays the search result based on the filter criteria.

Field Description
Report Form Displays the description of the report.
Click the link to view the DRAFT report PDF.
Recipient Company Displays the name of the company of the report recipient
Date Created Displays the date on which the report was created.
Date Sent Displays the date on which the report was transmitted to the recipient.

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Field Description
# of Pages Displays the number of pages in the report.
Attempts Displays the number of attempts made to transmit the report. If you are using
Right Fax, the value of this field is displayed as 0 even if the Right Fax had
attempted it multiple times. This is an unsupported feature in Right Fax.
Sender Displays the name of the sender of the report.
Lock State Displays the lock status of the report.
Sender Agency Name Displays the name of the agency that has generated the report
Status Displays the Report Status such as Scheduled, Generated, and so on.

User options

Option Description
View Transmission Displays the report in a PDF format.
Mark report as Marks the report for the selected row as submitted.
Submitted This option is displayed to only those users who have the access rights to mark a
report as submitted.
Remove transmission Failed transmissions can be removed using this option as it removes the
transmission log entry from the list.
A report whose status is pending cannot be transmitted.
Re-transmit This options allows reports to be re-generated and re-transmitted if report
generation had failed earlier. For failure in other stages of report transmission,
this option performs only retransmission.
Submit Multiple Multiple reports that are selected from the list can be marked as submitted
Reports simultaneously.
Re-transmit Multiple The status of multiple reports that are selected from the list can be changed to
pending, and those reports can be re-transmitted.
Remove Multiple Transmission of multiple reports that are selected from the list can be removed.
Transmissions

View routing details

Enter routing details in the text box.
Reports that appear in the Bulk Transmission section or the Bulk Print section do not display in
the Reports section of the Worklist.

Print your reports

The Bulk Print function displays a separate list for all Bulk Print events against reports.
1. Hover over the Worklist menu and select Bulk Print.
2. When the system opens the Bulk Print page, enter the appropriate information.
For more information, see:
• Bulk print user options

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Bulk print user options

Option Description
Remove Print Job Removes the print job entry from the list.
A report whose status is pending cannot be printed.
Re-print This option is displayed if the selected row has a status of failure or success.
Select this option to change the status back to pending and the re-print the
report.
Submit Multiple Multiple reports that are selected from the list can be marked as submitted
Reports simultaneously.
Re-print Multiple The status of multiple reports that are selected from the list can be changed to
pending, and those reports can be re-transmitted.
Remove Multiple Print Print jobs of multiple reports that are selected from the list can be removed.
Jobs

Store Expedited Reports in Documentum

Oracle Argus Safety lets you store your Expedited Reports in Documentum.
• Mark an Expedited Report as submitted from within Oracle Argus Safety to insert the
report into the Documentum system as a PDF.
• If the report is to be transmitted via fax or email, Oracle Argus Safety Service marks the
report as a successful submission in Documentum only after the fax or email transmission
has succeeded.

Track your Expedited Report submissions

In this section:
• Track ICSR outgoing status
• View ICSR transmit status
• ICSR Pending screen icons
• Track your failed ICSR imports

Track ICSR outgoing status

1. To monitor the Outgoing messages and Acknowledgements, go to Utilities, then select
ICSR, and click ICSR Transmit Status.
2. In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.
If the Agency is selected as Any, the search results display all ICSR messages and
acknowledgements for all receivers.

View ICSR transmit status

The Bulk ICSR Transmit function displays only those ICSR Reports that are awaiting
submission (not in submitted state) when transmitted from Bulk Report By Form to the Trading
partner.

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1. Hover over the Worklist menu and select Bulk ICSR Transmit.
The Bulk ICSR Transmit page appears with following tabs:
• Reports—Displays the status of individual ICSR Reports that are in the process of
being transmitted.
• Messages—Displays the status of ESM Messages which may contain multiple reports.
For E2B R2 and R3 batch XML, the XML messages are displayed in the Utilities > ICSR >
ICSR Transmit Status screen as a single record with a MSD icon. When you click the MSG
icon, the Message Acknowledgement Status - Webpage Dialog window opens. On the
window you can see the report number and authority/ company number values from the
first ICSR in the XML file.
2. Once reports have been successfully submitted and marked as submitted, they no longer
show when you go to Worklist and select Bulk Transmit, when you go to Worklist and
select Bulk Print, or when you go to Worklist and select Bulk ICSR transmit. To find a list
of all successfully submitted cases, go to Reports, then select Compliance, and click
Submitted.
3. Alternatively, go to Utilities, then select ICSR, and click ICSR Transmit Status.
On the Reports screen, in the Search Criteria section, you can filter by using the Local
Message # criteria. This allows you to filter for reports that belong to a particular batch by
providing the batch number.

Note:
If you selected the eMDR, eVAERS, or PMDA XML values in the Report
dropdown, then the Local Message# field is disabled.

For more information, see:

• Search for reports
• Search for ESM messages
• View search results

Search for reports

On the Reports tab, select the options to search for reports.

Field Description
Report Select the type of report from the drop-down list, as applicable.
To view the transmission status of the report, select one of the following reports
from the list:
• E2B
• eVAERS
• eMDR
• PMDA Device
Message Type Select a pre-defined message type.This field is set to ichicsr and is disabled if
report is set as eMDR or eVAERS.
Periodic Report This field is enabled for message type that are marked as Periodic in the
Message type codelist.
This field is disabled for eVAERS and eMDR.

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Field Description
Range Select a date range.
Search button Triggers search based on the search criteria.
Only show Check this checkbox to search for only those transmissions that have a failed
transmissions that status.
have reached a failure
state
Show all transmissions When this checkbox is checked by the user during the Search action, the
(submitted and system brings back any ICSR report that has received an error ACK
unsubmitted) having a (acknowledgement), irrespective of whether it has been marked as submitted or
error ACK not.
When this checkbox is checked, the checkbox Only show transmissions that
have reached a failure state is automatically unchecked.
Only show not When this is option is checked, the system displays ICSR reports for agencies,
suppressed which are not marked for ICSR suppression.
transmissions This option is checked by default. Users can uncheck this option to view all
ICSR reports for all agencies irrespective of being marked for ICSR
suppression.

Note:
The suppressed ICSR records have EDI In status
displayed in grey color as the physical file is not
generated.

Stage Legend Shows the status (through colors) corresponding to each stage.

Search for ESM messages

On the Messages tab, select the options to search for ESM messages.

Field Description
Report Select E2B, eVAERS or eMDR from the drop-down list to view the transmission
status of these reports.
Agency Trading Enter the agency or trading partner.
Partners
Transmit Date Range Select the transmit date range.
From
Range Select a range to auto-populate the Start Date and End Date.
The Range option is cleared if the Start Date or End Date is changed.

View search results

The Total Number of Rows section displays the search result based on the search criteria.
If the ICSR report in a result set row was already submitted, the system does not display the
following pop-up windows:
• Remove Transmission

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• Re-Transmit
• Mark as Submitted
• Re-Transmit Multiple
• Submit Multiple Reports
• ICSR Transmission History
For the same record above, the system, however, keeps the View Report Details and View
ICSR Report menus enabled.

Option Description
View Acknowledgement (Read Displays the Acknowledgment report.
only) This menu option is not displayed if ACK has not been received for
message.
View xml acknowledgement Displays business level acknowledgement.
View Reports Opens the Bulk Transmit ICSR in the report view for all the reports
in the message.
View Report Details Opens the existing Report Details dialog box in read-only mode.
(read -only)
View ICSR Report Opens the existing ICSR Viewer report.
(ICSR Viewer for the report)
ICSR Transmission History Opens the new Transmission History screen.
(Transmission History for the
selected report)

ICSR Pending screen icons

After you accept, authenticate and queue an ICSR report, the report is then processed by
background AG services. On the ICSR Pending screen, you can view the processing status of
your report. Each status is depicted by an icon and a status legend is displayed at the bottom
of the screen, as seen below:

To see the status changes, you can refresh your screen by using the search option.

Table 6-3 Status icons descriptions

Icon Status Description

Queued This icon is displayed when you accepted, authenticated
and queued the report for the AG service to process it.
When in this status, the actual processing has not started.
In addition, the check box next to the report is disabled and
you can not perform any actions on this report.
Processing This icon is displayed when the AG service has started
processing the report.
Note: Once processing is successful, the report will move to
the ICSR Processed screen. When in this status, the check
box next to the report is disabled and you can not perform
any actions on this report.

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Table 6-3 (Cont.) Status icons descriptions

Icon Status Description

Retry in progress If a report was not processed successfully, the system will
retry before it marks the report as a failure. b. The default
number of retries is 3. In addition, the number of retries that
can be attempted is determined by the following new profile
switch in Argus Console > Common profile Switch >
Background Services: Number of retries to be done for
an unsuccessful report to be picked for reprocessing by
Auto Accept AG Process. This profile switch allows values
from 1-999.
The time interval for re-processing is determined by the
below new profile switch in Argus: Number of minutes to
wait for a unsuccessful report to be picked for
reprocessing by Auto Accept AG Process The default
value for this switch is set at 60.
For the above two Console profile switches:
• You can enter a 3 digits number, however if zero is
used, the following warning message is displayed:
Please enter numeric value greater than zero.
• If you enter non-numeric and negative values, the
following warning message is displayed: This field can
not contain non - numeric value!
• If a save is successful, the following message is
displayed: Common profile has been saved’
You can see the error link with the reason for the report to
fail processing in the Details pop-up window.
When in this status, the check box next to the report is
disabled and you can not perform any actions on this report.
Failed If the report could not be processed by the background
service after three retries, then it is marked as Failed.
You can see the error link with the reason why the report
failed processing in the Details pop-up window.
When a report is in this status and the actual processing is
completed, you can attempt to accept or reject the report
again.
The check box for these reports is enabled, thus you can
select for Bulk accept or Reject.
Note: These reports can be selected along with pending
reports for Bulk Accept or Reject.

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Track your failed ICSR imports

The ICSR Failed Imports screen displays the list of failed reports and it is accessible from
Utilities > ICSR > ICSR Failed Imports.

You can view only the reports that failed during the import process. The reports appear in a
descending order based on the processed date, with the latest on top. The processed date
column also has a sorting option.
You can download these failed files for review by clicking the file name. To view details of the
failure, an error link is provided.
This screen is available to the users with access to the User group menu. The screen is
dependent on the enterprise that the user has logged in, and displays the reports that belong
to the same enterprise only.

Note:
All files that are processed from the IN folder, whether failed or not, are moved to the
Archive folder on the Interchange server.

You can use the Archive button to remove/ archive the report rows that you corrected and
processed.
The Print button is available to print your ICSR failed imports list. The print output contains the
filter criteria details in the header, such as the message type, file name and path, error details
and interchange processed date.
You can search the screen based on the following:
• File Name
• Message Type (All, MSG, ACK, Unknown)
• File Name Message Type (All, MSG, ACK, Unknown)
• Date (From and To, Date Range)
The following details are available for your failed reports:
• Message Type: This field indicates if the file is an incoming Report MSG, ACK or an
Unknown file.

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• File Name: the XML report file name is displayed alongside the complete path location and
the error link so you can view the error details.
• Processed Date: The processed date and time in the format Local Time / User Timezone.

Manage your Incoming ICSRs

To view the Incoming ICSR Reports screen, select Reports, and then click ICSR Pending
Reports. You can:
• View the ICSR reports sent by the agency or the trading partner.
• Process an incoming ICSR report.
• Check all the ICSR values of the reports sent and determine whether to accept or reject
the reports.
• Provide a user password and acceptance notes/rejection reason and accept or reject an
incoming ICSR report.
For more information, see:
• Track incoming ICSR reports
• Track bulk incoming ICSR reports
• Search for duplicate reports
• View processed ICSR reports
• Track ICSR incoming status
• Find overdue reports

Track incoming ICSR reports

Field Description
Message Type Allows selection of ICSR based on the message type for all allowed values for
the N.1.1 tag. By default, the drop-down is populated as ichicsr.
Trading Partner 1. To view report by a Trading Name, click Filter and select an agency.
2. To select multiple agencies, click Add in the Select Reporting Destinations
dialog box.

Product Name/Generic Click the Select button next to this text box.
Name A pop-up screen appears with a text box (2000 characters), a Search button,
an OK button, and a Cancel button.
This pop-up screen is called Generic Name or Product Name as per the radio
button selected in the Incoming ICSR Reports for which this popup was being
invoked.
This pop-up screen is titled Product Name when invoked from the Processed
ICSR Reports screen. The text box in the pop-up screen is auto-populated with
text entered in product name or generic name field on the corresponding
screen but can be the user updated.
Besides, when the user switches tabs between the Pending and Processed
Sub Tabs, the default processing page icon appears which information that it is
still processing and switching is not completed.

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Field Description
Report Type The supported report types for the case received are:
• Initial
• F-U
• Nullification
• Amendment
• Downgrade
Country of Incidence/ Displays the country where the incident occurred.
Primary Source
Country
Is/Will be assigned to Displays the site membership of the case.
this site This field appears in the search result.
Accept ICSR Imports ICSRs in a batch from ICSR Pending screen after selecting one or
more reports (E2B(R2) and/or E2B(R3).
Reject ICSR Reject an ICSR file of a batch.

For more information, see:

• Button and right-click options

Button and right-click options

Button Description
ICSR Viewer Select this right-click option to launch the ICSR viewer.

Note:
At the time of generating an ICSR report, some
characters entered in the case form may not be
displayed the same in the ICSR report. For the
example:
The ICSR report equivalent of the "&"
character entered in the case form is &.
Similarly, there are other such
characters that are represented
differently in the ICSR report.

View Error/Warning Select this right-click option to view all warning messages including M2
Message validation errors and Multiple ICSR Codes log.

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Button Description
Accept ICSR Selects the incoming ICSR report for both single and multiple acceptance.
Execute these steps to accept an ICSR Case:
1. Click the Accept ICSR Case button. The Acceptance of Initial Report
Confirmation dialog opens.
2. Enter your user password, date, and select a justification from the pre-
defined list of justifications.
3. Click OK.
After you click OK, the report is queued and then it moves through the
following stages: Queued, Proccessing, Failed and Retry in Progress.
Accepting Amendment report is the same accepting a Follow-up report. The
application supports importing attachments for the file types as configured in
the profile switch Case Processing > Valid attachment file
type.
Reject
View Validation Failure Opens the ICSR validation report (pdf) in the same format as it does at the
time of export. This validation report prints all the validations that are
categorized as soft validations for the import. Applicable for (R3) based ICSR
reports only.
Duplicate Search Select this right-click option to perform Duplicate Search for the case being
imported with the case present in the system.

Track bulk incoming ICSR reports

The Bulk Incoming ICR Reports enable you to import multiple ICSR reports that are sent by the
agency or trading partner.
During Bulk import, you can use the Message / Batch Number field option to retrieve reports
belonging to the same batch number. If no value is specified in this field, then all batch
numbers are selected.
You can retrieve reports belonging to a particular WWID with the World Wide Unique # field.
This field also supports wildcard search.
To view the Bulk Incoming Reports:
1. Select multiple reports from the Incoming ICSR Reports screen.
2. Click Accept ICSRs.
Note that:
• The reports that are imported can be a combination of Initial, Follow-up, and Nullification
reports.
• The only pre-requisite for this dialog box is that Case numbering should be set to auto-
numbering and not manually.
• Bulk Incoming Reports does not prevent the duplicate cases to be loaded into the system.

Search for duplicate reports

The Duplicate Search dialog box for an ICSR report enables you to search for possible
duplicate cases in the Oracle Argus Safety system. You can select different combinations of
search criteria. When you click Search, a list of cases that match the criteria you entered in

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Duplicate Search is displayed along with their duplicate search score. Review the search
results for a duplicate case. By default, the fields that are present in the ICSR Report are
checked for the Duplicate Search.
If the Enable Smart Duplicate Search switch is enabled in Argus Console > System
Configuration > Common Profile Switches > Case Processing > Duplicate
Search, then the application search records based on the Smart Duplicate Search algorithm,
otherwise the existing duplicate search algorithm is used.
Besides, the Score field appears in the result only when this switch is enabled.

For more information, see:

• Smart duplicate search
• View duplicate search options and actions
• Search duplicates for incoming review
• View differences report
• Accept initial E2B cases as follow-up

View duplicate search options and actions

Field Description
View ICSR Enables you to view the E2B report.
Reporter Displays the reporter involved with the case matching the search criteria.
This field appears in the search results.
Reference ID Searches on the following fields in the Oracle Argus Safety case:
• Additional Info > Case Reference ID
• Reporters > Reporter's Reference #
• Argus Case Number
Keyword By default, the first value from the incoming affiliate event appears.

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Action Description
Onset Date The date from when the first reaction or adverse event occurred.
Reference # National Regulatory Authority's Report Number, used as a Reference Number.

You can view differences between the current XML to be imported (a message that is not yet
imported into the database), the current case data in the database, and if a case has been
imported before, and the last imported case.

Note:
This button is available only for follow-up and nullification reports.

Search duplicates for incoming review

You can right-click the Case Number for a listed case and use the following options:

Right-click Option Description

Case Form Print This option is displayed for only those users who belong to the group with
access to Argus Console > Access Management > Groups >
Menu > File > Print.
This option allows you to print the case form report.
Case Summary This option is displayed for only those users who belong to the group with
access to Argus Console > Access Management > Groups >
Menu > File > Open Case Summary.
This option allows you to open the summary report of the case.
Medical Summary This option is displayed for only those users who belong to the group with
access to Argus Console > Access Management > Groups >
Menu > File > Print.
It displays the medical summary of the case.
Unlock/UnArchive Case This option is displayed to allow users to re-open the archived and locked
cases. On clicking this option, a Locked Case/Archived Case screen (as
applicable) is displayed. You need to enter your password along with any
remarks/notes and select a reason for your action to complete the unlocking/
unarchiving of the case.

Note:
This option is available only when the case is in
locked/archived status, and if the user has
privileges to lock/close the case, as per Argus
Console User Configuration >
Case Form settings.

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View differences report

You can view differences between the current XML to be imported (a message that is not yet
imported into the database), the current case data in the database, and if a case has been
imported before, the last imported case.

Note:
View Differences is available for follow-up reports only. This option is enabled only
when an initial case or case number is selected in the duplicate search output
section.

To view the View Difference report:

• From the Duplicate Search screen, click View Differences.
The ICSR Difference Report screen appears.
The differences in the ICSR reports appears as:
– Addition—New elements are highlighted in grey.
– Deletion—Deleted elements are highlighted in red.
– Modification—Modified elements are highlighted in yellow.
The following table describes the fields in the report.

Field Description
Trading Partner Allows you to view the Trading Partner name from whom the ICSR report is
received.

Note:
The Lock/Archive icon displayed with this field
denotes the status of the case.

DTD Version Allows you to view the DTD version of the follow-up ICSR report.
Case Number Displays the original case number of the ICSR report.
Follow Up # Displays the sequence number of the follow-up for the E2B report.
Total Number of Rows Allows you to select the type of ICSR Difference to view from: Current ICSR
vs. Current Case in Database
• Current ICSR vs. Last Imported ICSR
• Current Case in Database vs. Last Imported ICSR
Import Highlights the import differences.
ICSR Element Highlights the ICSR differences.
Current ICSR Highlights the differences in the current ICSR.
Current Case in Highlights the differences in the current case in the database.
Database
Last Imported ICSR Highlights the differences in the last imported ICSR.

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Field Description
Accept Follow-up Allows you to update the corresponding fields for the selected ICSR elements
in the Oracle Argus Safety case.
Reject Follow-up Does not update the corresponding fields for the selected ICSR elements in
the Oracle Argus Safety case.
Print List Provides the difference report in a PDF format.

Accept initial E2B cases as follow-up

This option is enabled only when an initial case or case number is selected in the duplicate
search output section.
1. To add an ICSR as a follow up to the Case Number (that is highlighted in the duplicate
search output section), click Accept Initial E2B Cases As Follow-Up.
2. Click OK when the following pop-up dialog box appears:
Do you want to add this ICSR as a Follow-up to the Case
Number<Num>?
The application attaches the incoming ICSR as a follow-up, to the selected case number
highlighted in the duplicate search screen.

View processed ICSR reports

The Processed ICSR Reports page contains a list of ICSR that are processed successfully or
processed with Errors/Warnings.
For more information, see:
• Search for reports
• View search results

Search for reports

Field Description
Trading Partner • To filter based on the Trading Partner, click Filter, and select an agency.
• To select multiple agencies, click Add from the Select Reporting
Destinations dialog box.
Product Name Enables you to select a Product Name as a search criterion.
For Product Name from Processed E2B Reports—searches all the Product
Names for all the processed cases.
The result set is limited to 1000 rows.
To update the Product or Generic Name, selects a value from the search
result, and click OK.

View search results

The search results appear in the Total Number of Rows section.

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Field Description
Interchange Date Displays the Case Number with which the case has been imported
on the specified interchange date.
ACK GEN Sent Displays the status of the ACK GEN.
• Yellow—Import is pending
• Orange—Import is accepted but with warnings or errors
• Red—Import is rejected
• Green—Successful import
EDI Out Displays the EDI Out status.
• Yellow—Pending to send the report out of the EDI / XML or
PHY out folders
• Green—Already sent out of the EDI / XML or PHY out folders
• Red—EDI gateway failed to send the report out of the EDI /
XML or PHY out folders
Warnings / Errors Click the binoculars icon to view warnings/errors associated, if
any.

Track ICSR incoming status

To monitor incoming ICSR:
1. From Utilities, go to ICSR, and select ICSR Receive Status.
2. In the Search Reports section, enter the search criteria, and click Search.
The search results appear in the Total Number of Rows section.
If the Agency is selected as Any, the search results display all ICSR messages and
acknowledgements for all receivers.
3. Click the Type Icon link to view message options.

Find overdue reports

1. On the Home page, hover over the Worklist menu and click Reports.
2. Click on the Days Past Due field on the right of the Total Number of Rows and if needed
click again to show Days Past Due in descending order (arrow pointing downwards).

3. To view all reports select ALL at top right of the screen.

For details on entering data in each section of the Total Number of Rows tab, see Total
Number of Rows link.

FAQs
• What is a scheduled report?
• What is a generated report?

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• What happens when a report is approved?

• What is the difference between submitting and transmitting a report?
• What happens when manually scheduling a Local Japan report?
• What happens when auto-scheduling a Local Japan report?
• What components are affected by the expedited reporting rules algorithm?
• When are follow-up reports created?
• When are the amendments created?
• Why can't I view a draft report?
• Why doesn't my draft report print a follow-up number?
• How does the Lock State Column under Reports > Compliance > Expedited allow me to
sort my cases?
• How do I view the status of my Expedited Report?
• How do I know if an unscheduled report is due soon or needs to be submitted?
• Where can I view single reports which have been generated as part of a periodic report?

What is a scheduled report?

A scheduled report allows the system to calculate a report based on the date received,
seriousness criteria, and reporting rule configuration if any. You can schedule any report. The
case data within the reports continues to be updated as the case is updated.

What is a generated report?

A generated report creates a draft report for review. The case needs to be locked for the
system to generate a report.

What happens when a report is approved?

Approving the report allows the User to sign off the report.

What is the difference between submitting and transmitting a report?

A report can be submitted to a regulatory authority either by printing it off and marking it as
submitted, or sending it electronically from within Oracle Argus Safety via fax, email or E2B.
Transmission is the electronic form of submitting a report.

What happens when manually scheduling a Local Japan report?

On Manual Scheduling of a report by a user, the application identifies if the report is a Local
Japan report by matching the Country of the License#, Destination and Report Form chosen by
the user in the Schedule New Report manual report scheduling dialog box with the Local
Reports Configuration.
If DLP is not enabled for Expedited Report Generation:
1. On the Global lock of a case by a user, the application generates the global reports but
does not generate any Local Japan reports.
2. The Local Japan reports shall be generated on subsequent local lock for Japan.

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If DLP is enabled for Expedited Report Generation, refer to the chapter in Oracle Argus Safety
Japan User's Guide > 4 Reports .
For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan
report by matching only the Destination and Report Form chosen by the user.
For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan
report by ignoring the country, matching only the Destination and Report Form chosen by
the user and if the Truly Local Case switch returns value > 0.
Note that if AUTO_FOLLOWUP_MANUAL switch is ON, the existing functionality of scheduling
a follow-up report for a manual report is retained as is and if the manual report was a local
report, the follow-up is treated as a local report.

What happens when auto-scheduling a Local Japan report?

On the Global lock of a case by a user, the application triggers the qualifying reporting rules
including the Japan reporting rules and schedule the relevant global and local reports. There
are modifications to the Report Generation functionality however, and is explained under
section Changes to Report Generation.
On the Local Lock of a case by a user, the Local Reporting Rules for Japan are triggered again
as follows, depending on the value in the configuration switch Case Form Configuration
| Auto Regulatory Scheduling:

• If the value is set to Always: The Local Japan reporting rules are triggered on case save
during the follow-up cycles of case processing when any of the local fields caused the
"Significant" data change. If any of the other fields caused the "Significant" data change,
then all the reporting rules are triggered as with the existing algorithm. Also, for the initial
case cycle, only local reporting rules are triggered on Local lock.
• If the value is set to Significant: The Local Japan reporting rules are triggered on Local
Lock but respecting the existing algorithm to check that Significant Follow-up was added
during the prior global lock cycle during the follow-up cycles. For the initial case cycle, as
with the existing algorithm, they trigger on Local lock.
• If the value is set to any value other than None, including Manual: A new checkbox called
Schedule Local Reports Only will be added under the Total Number of Rows section in
the Regulatory Reports tab of the Case Form. This checkbox is visible only when the
configuration switch Case Form Configuration > Auto Regulatory
Scheduling is not set to None. After the rules are successfully triggered, the application
unchecks the checkbox. If the checkbox is unchecked, the application triggers all the
qualifying reporting rules keeping the current functionality.

Note:
As a result of triggering of local reporting rules again, the Local reports that were
already scheduled during Global Lock may result in being overwritten or being
removed.

Force Distribution: If force distribute is checked for a reporting rule, the application triggers
that reporting rule as per the existing functionality. However, the generation and force
distribution of the Local Reports have the following modifications:

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1. When a Local reporting rule marked for "Force Distribute" has a local report that has
become due, the report is scheduled, generated and force distributed by performing the
global and local lock on the case using the existing AG Service Force Reporting process.
When a Local report that was already scheduled outside of the force distribution process
from a local reporting rule marked for "Force Distribute" has become due, the application
does not force generate this report keeping it consistent with the existing functionality.
2. For the above scenario, AG Service uses the one step global/local lock comment "Case
Globally and Locally locked for JP." (refer section Routing Comments Log and Case Print)
followed by the configured comments under Argus Console > Reporting >
Expedited screen > Forced Distribution comments.
Case Globally and Locally locked for JP. << Forced Distribution comments>>
3. After the report generation is complete, the case gets unlocked globally. AG Service uses
the one step global/local unlock comment Case Globally and Locally unlocked
for JP. (refer section Routing Comments Log and Case Print) followed by the configured
comments under Argus Console > Reporting > Expedited screen > Forced
Distribution comments.
Case Globally and Locally unlocked for JP. << Forced Distribution comments>>

What components are affected by the expedited reporting rules algorithm?

The expedited reporting rules algorithm affects the following:
• Suppression of duplicate reports
• Blinded or forced distribution

Suppression of duplicate reports

You can suppress duplicate expedited reports to be scheduled at the reporting destination
level, according to the following criteria:
• The Suppress Duplicate Reports option only applies to drug reports. It does not apply to
device reports.
• This option does not reduce the number of reporting rules the system evaluates. However,
it does prevent the system from scheduling and generating expedited reports that match
the duplication criteria.
• When you select Suppress Duplicate Reports, the system uses the following attributes to
determine whether the reports are duplicates of other reports:
– Report Form
– Reporting Destination
– Aware Date
• If two or more duplicate reports have different due dates (regardless of license type), the
system schedules the report with the earliest due date.

Blinded or forced distribution

The system enables you to configure the Blinding Study option for products in the case.
• When you check this checkbox, the system blinds the study products for the report being
sent to the reporting destination in a manner similar to the Bulk Reporting dialog box
option.

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• If you select either of the Blind Study product options (Reporting Rules or Bulk
Reporting), the system blinds the study product information on the report form.
• The system blinds only active blinded studies. It does not blind the following case reports
even if the Blind Study product is selected.
– Open Label Studies
– Study is eligible for unblinding - If the Study is Unblinding checkbox is not kept as
unchecked in study configuration, the user will be able to see the complete case data
even if he/she has protection enabled.
In cases where expedited reports are due, the system permits the user to force-distribute the
reports based on user-defined reporting rules, even if case processing is incomplete.
When you select the Force Distribution rule, the following occurs:
• If a case encounters a rule where a due report is locked, the system schedules the report
based on the rule and does the following:
– Generates the report on the due date.
– Dynamically replaces the current case comment with the force distribution case
comment.
– Transmits the report based on the preferences defined by the reporting destinations.
– Displays the status in the Worklist Bulk Transmit/Transmit ICSR dialog box.
• The AG Service Force Reporting process for expedited reports completes the process by:
– Checking the reports required for force distribution
– Locks the case (if it's not already locked)
– Generates the reports and makes sure it is ready for transmission
• The notes for the Case Locking/Unlocking are the same as those defined as the common
profile value for the Forces Distribution option; the system is the user.

When are follow-up reports created?

Follow-up reports are created depending on the following parameters:
• Data for a case changes.
• Update information for a case has been entered by entering follow-up information in the
General Information section of the General tab.
• Depending on the configuration set up by the Administrator, the system analyzes the
scheduled reports prior to the data changes to see if they are still required.
• If the system determines that they are not required, the report status is marked as
Downgrade. New reports are automatically scheduled, if required.
• If the system determines the report is still needed and needs to be updated, one of two
functions can take place depending on the configuration done by the Administrator:
– The system overwrites the report
– The system schedules a new report in addition to the old report
• If the system has been configured to overwrite the existing report, the report status
becomes New Data Available.

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• In the Worklist, the status for this report shows New Data Available for this report. When
you re-generate the report, you can select whether or not you would like to re-generate the
report with the new data.
• If the system is configured to create a Follow-up report, the previous report remains in its
current state and a new report is scheduled with the status of Scheduled.
• If a report has been previously submitted, this report is never deleted under any
configuration.

When are the amendments created?

If the initial or follow-up E2B(R3) reports are submitted to a Reporting Destination or Agency,
and the agency requests to send attachments, create the amendments by unlocking the case
as significant follow-up and check the Amendment check box in the Case Form > General
Tab > Follow-up section. Besides, enter the reason as well to create the amendments.

You can include attachments and provide details of the attachments in the Case Summary.
Amendment reports are auto-scheduled for the cases with Significant Amendments only, where
the reporting destination is configured with an E2B(R3) profile.
Follow-up reports are auto-scheduled for the cases with Significant Amendments, where the
reporting destination is configured other than E2B and E2B(R2) reports.
To manually schedule the Amendment reports for E2B(R3) for Significant Amendments or Non
Significant Amendments, use the Scheduling New Expedited Report dialog. Select the Aware
date pertaining to the amendment and schedule an E2B(R3) report. Aware date pertaining to
an amendment can be identified by text (A) appended to the Aware date.

Note:
Oracle recommends that you have only one amendment for an Aware date, else it
may be difficult to identify the latest amendment from the Aware date drop-down in
the Scheduling New Expedited Report dialog.

When you manually schedule a report other than E2B or E2B(R2) for an Amendment Aware
date, then the follow-up report is scheduled if there is a previously submitted report of the
same report type to the same agency, else an initial report is scheduled.

Note:
You can create amendments only when a previously submitted E2B(R3) report
exists.

Why can't I view a draft report?

You can only view a Draft report if the relevant case is unlocked.

Why doesn't my draft report print a follow-up number?

The following expedited report forms do not print a follow-up number when the user selects
DRAFT on the Regulatory Reports tab or when they select the Quick Launch Draft option:

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• US FDA MedWatch Drug/Device

• US FDA VAERS
• CIOMS I/CIOMS I (Local)
• French CERFA
• Spanish Spontaneous/Clinical

How does the Lock State Column under Reports > Compliance > Expedited
allow me to sort my cases?
Click the Lock State header row to sort on the following category of cases. A pop-up window
appears, with the following sorting options:
• Lock State
• SUSAR
• Exp/Per
Click the required option to sort cases based on the selected case categorization.
Lock icons

Icon... Identifies...
A case marked for a Periodic ICSR submission.

A locked case.

An unlocked case

A SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Lock icon options

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Field Description
Report Details Displays specific information about the report as entered in the Regulatory
Reports section.
The information displayed in the fields of the Report Details dialog box is
fetched from the data entered in the Regulatory Reports section of Case Form.

How do I view the status of my Expedited Report?

To... Do...
View the regulatory reports for a particular Open the Regulatory Reports tab of the Case Form.
case (scheduled, generated and submitted)
View all scheduled, generated, and approved Select Reports from the Worklist menu.
reports, as well as other outstanding action
items
View a list of all scheduled, generated, and Select Compliance > Expedited from the
approved reports Reports menu.
View all the submitted reports in the system Select Compliance > Submitted from the
Reports menu.

How do I know if an unscheduled report is due soon or needs to be

submitted?
As report scheduling is commonly configured to be executed when significant changes are
made to a case, the expedited reports may be delayed if a case never gets locked. You cannot
know that a report is late if it has never been scheduled. To address this potential compliance
issue Oracle Argus Safety assesses case reportability prior to formal report scheduling.
Workflow and Expedited Status monitoring screens identify unlocked cases due soon.
• To view a list of unlocked cases with reports due, select Dashboards, and then click
Reports Due Soon.
The Unlocked Cases with Possible Reports Due Soon screen appears.
• The Workflow and Expedited status include another report with cases that have not had
reports scheduled but that may generate a report with a due date in the near future. This
graph is displayed below the graph detailing the actual case status. The reports included in
this sub-dashboard are limited to the filter criteria specified for the main dashboard.
To view a Worklist with cases of the selected state (red or yellow), click the graphical bar.

Where can I view single reports which have been generated as part of a
periodic report?
The Periodic folder contains single case report forms (MedWatch, VAERS or CIOMS) that were
generated as part of a Periodic Report.
• Pending Reports by Destination
• Submitted Reports by Destination
• Non-submitted Reports by Destination

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Periodic reporting plays a key role in the safety assessment of drugs. It involves the
compilation of safety data for a drug over a prolonged period of time (months or years), as
opposed to single-case reporting which, by definition, involves only individual AE reports. The
advantage of Periodic reporting is that it provides a broader view of the safety profile of a drug.
For more information, see:
• Prepare content for periodic reports
• View scheduled periodic report information
• Submit a periodic report
• Track your periodic report submission

Prepare content for periodic reports

In this section:
• Prepare your aggregate reports
• Periodic report types
• Prepare content for a Clinical Trial Periodic Report
• Prepare content for an ICH PSUR
• Prepare content for a US IND periodic report
• Prepare content for an NDA periodic report

Prepare your aggregate reports

These reports are executed in the background through the AG Services. A new Oracle Argus
Safety service named Batch Aggregate Report Generation is available for this purpose.
For more information, see:
• Understand aggregate reports
• View saved aggregate reports
• Create a Case Data Analysis report
• Create a CIOMS II Line Listing report
• Create a case listing report
• Check aggregate report execution status

Understand aggregate reports

• The date and time printed on the following reports are the date and time the query is
executed for case qualification. They are not the date/time the query was completed and
the report obtained Web Server.

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– Case Listing Report

– Case Data Analysis Report
• The system converts the following elements that display in the case form as actual text on
the Case Listing and CIOMS II Line Listing reports:
– Duration of Administration
– Time Between First Dose/Primary Event
– Time between Last Dose/Primary Event
• Capture the report follow up number in the Regulatory Reports section. The system prints
the report follow-up number on the expedited reports in the following format:
F/U# X
where:
X is the report follow-up number.
• For an initial report, the system prints initial in the column.
• If there are no reports for the case in the Case Listing/CIOMS II Line Listing, the column is
left blank.
• This option is available on the CIOMS II Line Listing/Case Listing reports.
• The system uses the IE offset of the client workstation to print the date and time
component for all system-calculated fields on the Case Listing/CIOMS II Line Listing
reports.
• You can filter cases in the following aggregate reports based on the lock/archived date.
• When you select Case Locked/Archived date, the system limits the cases based on
whether the case is locked/archived within the specified time frame.
• The lock date is considered the locked date.
• If you select the Case Patient or Reporter Information in the Case Listing or CIOMS II
Line Listing reports and the Protect Confidentiality field is checked for the Patient or
Reporter Information, the application does not print the following information in Case
Listing or in the CIOMS II Line Listing report:
– Data from the Patient information and Patient details section, excluding Race
information
– Data from Reporter information
• If you do not have permission to view the reporter or patient information, the
corresponding reporter or patient elements selected on the Case Listing or CIOMS II Line
Listing report are blank.

View saved aggregate reports

The System Reports Library displays the list of the saved aggregate reports including Case
Data Analysis, Case Listing and CIOMS II Line listing reports. This screen displays only the
reports either created by the logged in user or the reports that are shared for your user group
during report creation.
• The Aggregate report supports only PDF or CSV formats.
• The system report library screen, provides the way to filter the reports through:
– Report Name
– Description

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– Report Type
– Output Type
– Author
– Last Modified
– Available for Periodic
– Shared
• The reports can be executed through the Print option. When you click Print, the application
opens the Report Batch Printing dialog box, where you can run or schedule the report for
the desired format (PDF/CSV). You can send an email for the completion status.
• The open option allows to open and edit the memorized reports.
• If the user clicks Transmit, the system generates the selected report and starts the
transmit process. The system displays the Recipient pop-up.

Note:
A shared report can only be deleted by the Administrator or the user who created it.

Create a Case Data Analysis report

The Case Data Analysis Report enables you to view quantities of cases over time in a Cross-
Tabular Fashion.
1. Select Reports, then select Aggregate Reports, and click Case Data Analysis.
2. In the Case Data Analysis Report view, select the information that must appear in the
report.
3. In Row1, select the field the system uses to group cases by row.
4. In Column1, select the data the system uses to group cases by column.
5. In Row2, select the field by which each Row1 item will be categorized.
6. In Column2, select the field by which each Column1 item will be categorized.
7. Select a product family to which the report applies, if appropriate.
8. In Selection for Row1, select the value for Row 1 by which the report must be restricted.
9. Specify an advanced condition, as appropriate.
10. Select Report Number of Cases or Report Number of Events, depending on the number
of cases or the number of events to be entered in the report.
11. If you select Report Number of Events, you can specify the kind of events (Serious
Listed, Non-Serious Listed, Serious Unlisted, or Non-Serious Unlisted) that will
appear in the report.
12. Select whether only the top few items should be displayed and enter the number of items
that should be displayed.
13. Check the Show% of Total checkbox to specify the percentage in each cell in the report.

14. Check the Blinded checkbox to hide blinded information in the report. This field is
unchecked and disabled for a restricted user.

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15. Check the Use Case Search Results checkbox to limit the Case Data Analysis only to the
cases present in the Case Search dialog box.
16. Specify a date range for the cases that will appear in the report.

17. Enter a title for the report.

18. Click the Share this report with other users if there is a need to share the report/report
output to other users. Note that the report may contain sensitive data. By default, the report
is shared with all users. You can restrict it through Group, where the allowed user groups
can be selected. When a report is shared for a user group, only members of that group and
the report creator can access the report further.
19. The report can be used in the periodic report using Make available for use in Periodic
Reports.
20. Click Print to execute the report in background. This report can later be viewed under
system reports library.
21. The memorize button saves the report in the application. It does not execute the report.

Create a CIOMS II Line Listing report

The CIOMS II line listing report is a common format desired by Drug Safety professionals for
reviewing cases. Create this report from the CIOMS II Line Listing dialog box.
1. Select Reports, then select Aggregate Reports, and click CIOMS II Line Listing.
2. On the CIOMS II Line Listing Criteria tab, select information for the header, footer, product
family, advanced condition (if any), cases to include, and date.
3. Select either the Case Creation Date or Case Receipt Date radio button and specify a
date range to run the report.

Note:
If you perform a search and return a list of cases to the Case Search screen, the
Use Case Search Results is visible. Checking this box will disable all selection
criteria with the exception of Include Unlocked Cases. For example, the
Advanced Condition and Date Range will be disabled.

4. In the Line Listing tab, add or remove the appropriate fields.

5. In the Grouping tab, add or remove elements, insert a page break and change the sort
order (if desired).
6. Click Memorize to open the Memorized Report dialog box.
The Memorize button saves the report in the application. It does not execute the report.
7. Click Print to execute the report in background. This report can later be viewed under
system reports library.
This report can be shared with other users of Argus and the sharing can be restricted
through the User Group selection.

Create a case listing report

The Case Listing Report enables you to filter cases based on Case Initial Receipt Date and
Case Creation Date. You can select multiple entities from the List of available fields using the
CTRL+CLICK functionality.

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1. Select Reports, then select Aggregate Reports, and click Case Listing.
2. When the system opens the Case Listing Reports view select the information to appear on
the report.
3. Select the fields that are to appear in the report from the Available Fields list.
4. Click Add. Repeat this process for each field that must appear in the report.
5. Use Move Up and Move Down to arrange the fields in the Selected Fields list.
6. Check the Blinded checkbox to hide blinded information in the report.
7. Specify an Advanced Condition, if appropriate.
8. Specify a date range for the cases to be displayed in the report.
9. If you check the Include in Header checkbox, the selected date range is displayed on the
report.
10. Under Sorting Order, select the fields by which the cases will be sorted. You cannot sort
the cases by fields that do not appear on the report.
11. Enter the title of the report.

12. Click Memorize to memorize the criteria specified for a particular report.

The Memorized Report dialog box appears.

13. Save, Delete or Cancel the report, as applicable.

14. Click OK in the Case Listing Reports screen to generate the report. The report will be
generated in PDF format.

Check aggregate report execution status

Go to Reports, then select Compliance, and click Report Generation Status.
This screen displays the status of report generation for both Periodic and Aggregate reports.
The Aggregate Reports can be filtered using the report type filter.

Periodic report types

On the Reports menu, hover over the Periodic Reports option, to go to any of the Periodic
Reports.
You can create the following periodic reports:
• Clinical Trial Periodic Reports
• ICH PSUR Reports
• US IND Periodic Reports
• US NDA Periodic Reports
For more information, see:
• Store periodic reports in Documentum
• View a summary of periodic regulatory reports
• Use the library page

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Store periodic reports in Documentum

When you approve an expedited report from within Oracle Argus Safety, the system exports
the report as a PDF file and saves it in the Documentum database by Oracle Argus Safety
Service. From this point, you can perform document reviews within the Documentum system.
When the report is ready to be submitted, mark the report as Submitted from within Oracle
Argus. Oracle Argus Safety Service updates the status of the report within Documentum to
Submitted.
If the report is to be transmitted via fax or email, Oracle Argus Safety Service marks the report
as a successful submission in Documentum only after the fax or email transmission has
succeeded.

View a summary of periodic regulatory reports

You can select any of the following options in viewing the summary of a periodic regulatory
report:
• To view the regulatory reports for a particular case (scheduled, generated, and submitted),
open the Regulatory Reports tab of the Case Form.
• To view all scheduled, generated, and approved reports, as well as other outstanding
action items assigned to you or your user group, select Reports in the Worklist menu.
• To view a list of all scheduled, generated, and approved periodic reports, select Periodic
Reports from the Reports > Compliance menu.

Use the library page

The Periodic report has a library page from where you can create a new report, execute an
already created report, view the output and so on.
• PSUR (legacy PBRER, PSUR and Flexible PBRER, PMAR reports)
• CTPR (legacy CTPR and Flexible DSUR reports)
All fields that are used by the Flexible DSUR is highlighted with blue BIP icon.
• IND
• NDA
While a report is running, it can be modified or run again until the previous run is complete.

Prepare content for a Clinical Trial Periodic Report

The Clinical Trial Periodic Reports (CTPR) are created to report the IND Annual reports and
EU Clinical Trial Directive line listing reports to FDA.
For more information, see:
• Create a Clinical Trial Periodic Report
• Enter common fields information
• Configure subject in the report header
• Select products to include in CTPR
• Configure license or study in the report header

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• Select inclusion criteria

• Use the Data Lock Point (DLP) version
• Use DLP queries for dates
• Use As of Reporting function
• Find DLP and As of Query functionality
• Include line listing
• Add data elements
• View selected data elements
• Group cases
• Specify summary tabulations for line listing
• Generate single case submission report
• Select summary listing
• Schedule the report
• Setup frequency of the scheduled reports
• Configure security level of the report
• Use report templates

Create a Clinical Trial Periodic Report

1. Select Reports, then select Periodic, and click CTPR (Clinical Trial Periodic Reports) to
open a list of CTPR Reports.
2. To create a new report from an existing report in the list, click Copy or Modify.
3. Click New Report to create an entirely new report. The Clinical Trial Periodic Reports pop-
up window opens.
4. Enter an appropriate name for the report under Report Name.
Use the tabs in this pop-up window to configure the CTPR.

Enter common fields information

The Report Name, Report Category and Report Sub-Category fields are common to all tabs of
the Reports.

Field Description
Report Name Enter a name for the Report. The name entered here is displayed in the
Reports menu.
Report Category 1. Select a category for the Report. This is displayed in the Reports menu.
2. Select New to define a subcategory within the report category.
The Periodic Report Category dialog box is displayed.
3. Enter a category name in Category and click OK.
4. The category is entered in the Report Category drop-down list.

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Field Description
Report Sub Category 1. Select a subcategory for the report.
2. Select New to define a subcategory within the report sub-category.
The Periodic Report Category dialog box is displayed.
3. Enter a category name in Category and click OK.
4. The category is entered in the Report Sub-Category drop-down list.

Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency,
products, etc. for which the CTPR is applicable.

Field Description
Available Reporting Displays the list of configured Regulatory Agencies. Select an agency from the
Destination list displayed in Reporting Destination and click Add to add the report to the
Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.
Likewise, select an agency from the Selected Destination list and click
Remove to remove it from the selected destination.
Primary Agency Select the primary agency for the report.
When you submit a Periodic report, it goes to the selected Primary Agency.
Selected Reporting Displays the list of agencies where the report is being sent. Select an agency
Destination from the list displayed in Reporting Destination and click Add to add the
report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.
Likewise, select an agency from the Selected Destination list and click
Remove to prevent it from being sent to the selected destination.
Ingredient Automatically displays the Ingredient as provided in the Subject of Report
dialog box.
You can choose whether to view this field or not. Click the checkbox displayed
with this field to hide or view it.
Trade Name Automatically displays the Trade Name(s). Multiple trade names are also
displayed together, separated by commas.
You can choose whether to view this field or not. Check the checkbox
displayed with this field to hide or view it.
International Birth Date Automatically displays the earliest license awarded date, when a user selects
an Ingredient and a Product.
You can choose whether to view this field or not. Check the checkbox
displayed with this field to hide or view it.
Print all configuration Mark this box to print out the configuration of this report when the report is
criteria on separate printed. This is only available when PDF option is selected during printing.
cover page

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Field Description
Print page numbers on When checked, this option enables the user to print page numbers on a
reports periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.
• The Include Periodic Page Numbering option in the CTPR Summary
Tabulations CIOMS Report section is inactive and grayed out.
• The User Periodic Numbering on the report option on CTPR Summary
Tabulations FDA CTPR support section is grayed out and inactive.
• The Additional Separate Page Numbering for UD Summaries option
on the CTPR UD Summaries tab is grayed out and inactive.
• The system removes all existing report page numbering and the option to
check page number checkboxes on the report configuration tabs are
grayed out and inactive.
Allow access to report When the report is run as final, it creates a Hit List, which can be retrieved
cases through Case from other areas of the application where advanced conditions can be
Series selected. Click this checkbox to report cases through the Hit List.

Select products to include in CTPR

The Product Selection tab enables you to select the products included in the CTPR report.

Field Description
Available Ingredients Displays the list containing the Ingredients used for the product configuration.
Select an ingredient from the list displayed in Available Ingredients and click
Add/Remove to add or remove the ingredient.
You can select multiple ingredients at a time.
Filter Enter an Ingredient name and click Filter to search for the entered ingredient
within the Available list of Ingredients.
Selected Ingredients Displays the list of ingredients selected from the Available Ingredients list.
Available Countries This list is auto-populated and displays only the countries with a license
containing the ingredient selected from the Available Ingredients list.
Selected Countries Displays the countries selected from the Available Countries list.
Indication This list contains the Indication configured for the product containing the
ingredients in the Available Ingredients section. The selections made from
this list get displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL
key and clicking the different Indication entities.
Formulation This list contains the Formulation configured for the product containing the
ingredients in the Available Ingredients section. The selections made from
this list get displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the
CTRL key and clicking the different Indication entities.

Configure license or study in the report header

The License or Study tab is used to configure the report header and to specify the agency,
products, etc. for which the CTPR will be applicable.

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Field Description
Available Licenses Contains licenses that use the ingredient selected in the Ingredient field. This
field is automatically populated when an ingredient has been selected.
Selected Licenses Displays the licenses selected from the Available Licenses list by clicking
Add/Add All. You can select Licenses that are related to different ingredients
for a report.
Available Studies Contains studies that use the ingredient selected in the Ingredient field. This
field is automatically populated when an ingredient has been selected.
Selected Studies Displays the studies selected in the Available Studies list by clicking Add/Add
All. You can select studies that are related to different ingredients for a report.

Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a
periodic report.
The top section of the dialog box allows you to specify the type of cases that will be included in
the periodic report.
Inclusion criteria of the reports considers listedness of all blinded products configured in the
study and present in the case while still being in the blinded state. Such blinded products are
included in the periodic report when event-level listedness is considered.

Field Description
Case Creation Date Allows you to specify a range of cases by the date when the case was created.
Case Receipt Date Allows you to specify a range of cases by the initial receipt date.

Note:
The Date Range is only available when an
unscheduled CTPR is being created. You must
specify only one date range out of Case
Creation Date and Case Receipt Date.

Case Locked/Archived Allows you to specify the date when the case was locked/archived.
Date
Use Current Version Allows you to use the latest revision to populate the data within the selected
reports.
Use DLP Version Allows you to use the case data of the version as of the specified DLP Version.
Age Groups Allows you to include or exclude cases based on the patient's age group.
Select all the age group categories that apply.

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Field Description
Restrict Cases to References study configuration to determine if the case was submitted during
countries where studies the dates the study was active.
are active

Note:
This option is available only if a study is selected
from the Available Studies section in the
License/Study tab.

It should not be used for Centrally approved products (CAP), which only have
an EU license.
Advanced Condition Allows you to specify an advanced condition that must be satisfied by each
case that is included in the report. Ensure that the advanced condition or the
advanced condition query set that is specified here does not contradict any
other criteria specified in the dialog box.
Datasheet for Select the Datasheet to look against for Listedness when running the report.
Listedness

Note:
Select the ALL datasheet to use the most
conservative listedness for the primary event, or
the Case Listedness for the tabulation.

Use Assessment in When selected, the CTPR Report will use the Case Event Assessment when
Cases performing datasheet listedness calculations.
Re-assess cases When selected, the CTPR will re-assess the cases in the line listing based on
against datasheet in the Active Datasheet on or before the Start Date of the Reporting period.
effect at the beginning
Re-assess cases When selected, the CTPR will re-assess the case in the line listing based on
against datasheet in the Active Datasheets on or closest to the end date of the CTPR Reporting
effect at end end date range without exceeding that date.
Reference Type Select the reference type to be displayed on the Main Listing if Clinical Study
(Clinical Reference Reference is selected as a Data Element in the Available Data Elements
Data Element) section of the Line Listing tab.
Expeditable Only This option is enabled only when an agency has been specified on the Subject
of Report tab. Check this option to include only those cases that have
submitted expedited reports to the specified Primary Agency.
Exclude Follow-up Follow-up cases are cases with a significant follow-up in the Clinical Trial
cases reporting period where the initial receipt date is in a prior period. Check this
option to exclude follow-up cases from appearing on the Clinical Trial report.
Include Unlocked Cases Check this option to allow cases that have not been locked for reporting to
appear on the report.
Use Datasheet Allows you to select datasheet for a report to make UDF tabulations. If no
Assessment for UDF datasheet is selected, the most conservative listedness is chosen, such as
Tabulations Unlisted followed by Listed.
Add Cases not included Allows you to add cases which were not included in the previous reporting
in previous reporting period.
period You can enter the start date of the period in the Start Date field.

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Use the Data Lock Point (DLP) version

DLP primarily uses two processes:
• Last Completed Version—This option always uses the case version with the last lock that
existed prior to the DLP or As of Reporting date. This option does not enable data
cleaning
DLP saves only the last revision when multiple saves are performed in the same job
session.
• Next Completed Version—This option uses the current case lock or the next following case
lock if the case version was initiated prior to the DLP or the As of Reporting date with two
exceptions:
– If there is no case lock for the current version that was received prior to the DLP, the
last (current) case revision is used.
– If there is a case version after the case lock that was created for the purpose of data
cleaning, it is to be used instead of the first locked case revision.
– If there are multiple contiguous case versions following the first case lock for the
purpose of data cleaning, the last case data cleaning version is used.

Note:
The Data Cleaning option is available only with the DLP option Use Next
Completed Version (Includes Data Cleaning).

Use DLP queries for dates

You can perform DLP queries for the following:
• Receipt Date - date entered by the user during case creation.
• Initial/Follow up Receipt Date
• Safety/Safety Follow up Receipt Date
• System Date (Case Creation Date) - date the case was physically entered.

Use As of Reporting function

The As of Reporting function returns the same case version results as the DLP Options, with
the only difference that the date depends on the As of date instead of a DLP date.

Find DLP and As of Query functionality

The DLP and As of Query functionality is available in the following application modules:
• Periodic Reports
– PSUR including all User defined Tabulations and expedited reports within the Periodic
Report
– CTPR including all User defined Tabulations and expedited reports within the Periodic
Report
– IND including all User defined Tabulations

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– NDA including all User defined Tabulations and expedited reports within the Periodic
Report
• System Reports
– CIOMS II Line Listing
– CDA Reports
– Case Listing Reports

Include line listing

Field Description
Include Line Listing Allows you to select whether you want the Line Listing Data Elements printed
with the CTPR Report.
From the Available Data Elements, select As determined listedness to print
listedness.
For Blinded clinical trial cases, when the Include datasheet/licenses for all
the blinded study products common profile switch is checked, then
listedness is printed against the default study product.
Blind Line Listing and Hides the selected listings from being displayed
Summary Tabulations

Add data elements

Select the checkbox associated with a data element (field) to add that field to the report.
• By default, the system prints unavailable fields on the report, and they cannot be changed.
• Required data elements are printed as columns in the report. The optional data elements
are printed as separate rows below the column data for each case.

View selected data elements

This section lists the selected elements and enables you to arrange the order in which these
are to be printed. Click the Up or Down buttons to arrange the listed elements above or below
in order of priority.

Field Description
MedDRA Hierarchy Select Cases to populate the data from the case data. Select Dictionary to
from Cases/Dictionary populate the data from the MedDRA dictionary.
Print Only the Term Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as
(Preferred Term or per the selected radio button. Select the PT option to print only the preferred
Lower Level Term) term and not the verbatim description.
Print Dose Text in place Prints the dosage and frequency information from Dose Description field
of regimen dose instead of Regimen Dose.
Indicate if case was This checkbox is selected if a primary agency has been selected in the Subject
expedited previously of Report tab. Cases for which an expedited report was previously submitted to
the selected authority are marked with an asterisk.
Local Language Allows a user to specify which Local language for a multi-language field is to
be printed. Namely, the Abbreviated Narrative field.

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Field Description
Print event info Select this checkbox to print the Seriousness, Listedness and Causality
(Serious, Un-listed, under the Event Verbatim column.
Causal) as Column Note: Events having listedness of Unknown are considered Unlisted. If only
diagnoses are assessed for event assessment, the events which are
associated with a Diagnosis but have been marked with Diagnosis as Np
display '-' for both listedness and causality.
List cases only once, Select this option to view the details of cases in the Main Line Listing only
under the primary event once under the Primary Event.
List cases under all Select this option to view the details of cases in the Main Line Listing only
events, details under once under the Primary Event, while non-primary events are listed under their
the primary event respective event hierarchy with a reference to the primary event body system.
Therefore, use this option when grouping on Main Line Listing is by the
Event Body System.
Print Product Indication Select this option to print Product Indication for the product selected in the
for the product selected report.
in the report

Group cases

Field Description
Available Groupings Allows a user to group cases together from the given list. Select the desired
groupings from the list and click Add to move the grouping to the Selected
Groupings list. Up to 10 grouping options can be selected.
Selected Groupings Lists the added groupings made available from the Available Groupings list,
and reports the groups in the order they were selected.
Ascending Select this checkbox to sort the selected entities in ascending order.
Page Break Select this checkbox to start the cases from a new page, while also keeping
the sorting together for every selected page break.
Available Sortings Allows a user to sort cases together from the given list. Select the desired
sortings from the list and click Add to move the sorting to the Selected
Sortings list.
Selected Sortings Allows a user to further sort cases without a total count for each sorted item.
Up to 3 levels of sorting can be selected from the Available Sortings list.

Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/Listings will
appear along with the line listing.

Field Description
Include Index of Cases Create an index page of case numbers, for all cases included in the CTPR.
in Line Listing

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Field Description
Include Summary of This option creates a sub-report of cases missing one of the following items:
Cases Missing • Seriousness
Assessments • Case Causality
• Case Listedness
• Case Outcome
• Event Causality
• Event Listedness
Click this checkbox to create one or both of the following sub reports:
Cases Missing Assessments - This sub-report displays cases that have
been included in the CTPR line listing, but one or more of the following have
not been assessed:
• Case Seriousness
• Case Causality
• Case Listedness
• Case Outcome
• Event Causality
• Event Listedness
Cases Not Included in Report - This sub-report displays cases that have not
been included in the CTPR line listing as a result of missing one or more of the
following items:
• Lock Status
• Safety Date
• Uncoded Event
• Causality
Count of Cases per This option prints a Sub Report that counts the number of cases versus the
Report Type Report Type, based on the cases within the CTPR.
The Cases per Report Type can be either of the following:
Count Cases with Initial Expedited Reports: Counts cases with initial
Expedited report.
Count of cases with Follow-up Expedited report: Counts cases with Follow-up
Expedited report.
Total Count of Initial Cases in the Report: Counts any (serious - non-
serious) cases received during the reporting period.
Total Count of Follow-up Cases in the Report: Counts any (serious - non-
serious) follow-up cases entered during the reporting period.
Cumulative Count: Count of cases received from the start of the trial.
Event Count per Study Creates a sub-report with Event count per Study Drug based on the selected
Drug causality. 2 configurations are possible as to allow for a count of related events
vs. non-related events.
All Drugs in Single Suppresses 0 current columns (with their cumulative) and print everything in a
Table single cross tab.
Grouped by Drug Prints a cross tab report for every product. Prints the cumulative totals even if
the current period has no events.

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Field Description
Event Type to Include Prints SUSAR events on the CTPR Report based on the option selected from
the drop-down list:
• Separate counts of SUSAR and non-SUSAR events
Prints SUSAR and non-SUSAR events listed separately. SUSAR events
are marked with an asterisk
• Combined count of SUSAR and non-SUSAR event
Prints SUSARs. Normal events are grouped into one (current functionality)
• Only count SUSAR events
Prints Only SUSARs. Namely, non-SUSARs would not be printed.
Include Line Listing Select this checkbox to view a pre-defined summary tabulation of Report type,
Tabulation Seriousness and Listedness of all cases in the CTPR.
Include Initial Cases Select this checkbox to include initial cases in the CTPR tabulation.
Additional Expedited Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its
Report Forms (CIOMS/ respective regulatory agency (as selection), for all cases in the report. It also
MedWatch/VAERS) provides an option to have (or not have) a watermark in the forms.
When MedWatch is selected for PSUR, CTPR, and NDA, then the Reporting
Destination drop-down displays only those agencies that has MedWatch profile
(standard or custom) configured in the Reports > Periodic Reports
> ICH PSUR or CTPR > Summary Tabulations >
Additional Expedited Report Forms (CIOMS/ MedWatch/
VAERS)> Print MedWatch > Forms of Agency section.

CIOMS reports—fields descriptions

Field Description
Print CIOMS reports for Allows a user to print CIOMS I forms for all Serious or Unlisted (Case Level)
serious/unlisted cases cases appearing in the CTPR.
CIOMS contain Internal or Other text printed on them when the CTPR is
printed using the Internal or Other option.
Include Periodic Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1 of 2,
Numbering on the A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to also contain the
CIOMS reports Periodic paging of each CIOMS report.

Cumulative summary—fields descriptions

Field Description
Include Cumulative Select the checkbox to create a sub-report count of events, grouped by
Summary Product and Body System (SOC) and sorted by Preferred Term. The sub-
report contains a previous date range count of events (comparative date
range), a current date range count (current CTPR date range) and a
cumulative count (all dates) of events assessed against the product(s) of the
CTPR and matching the inclusion criteria.
Comparative Date Allows a user to specify the previous date range as a comparison date for the
Range events counted, and therefore should not overlap with the current date range
specified on the CTPR inclusion criteria tab.

FDA CTPR support—fields descriptions

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Field Description
Include Adverse Event Summary Select this option to generate a sub-report of events from the line
listing. This sub report is grouped by Body System and Preferred
Term.

Note:
This section can be used if the
company has obtained an FDA waiver
to submit a CTPR instead of an NDA
report.

Causality Select the desired causality from the list.

Ignore - Counts events regardless of causality assessment.
Causal - Counts events where the causality is considered
reportable in the Causality Category configuration in List
Maintenance.
Not Causal - Counts events where the causality is considered non-
reportable in the Causality Category configuration in List
Maintenance.
As Determined - Counts events where As Determined causality
meets the above selected causality criteria.
As Reported - Counts events where As Reported causality meets
the above selected causality criteria.
Both - Counts events where both As Reported and As
Determined causality meet the above causality criteria.
Either - Counts events where either the As Reported or As
Determined causality meets the causality criteria.
Only Cases with HCP Reporter Select this checkbox to include events for only those cases that
feature an HCP reporter.
Diagnosis Select this radio button to ensure that only events marked as
diagnosis are counted.
Diagnosis & Symptoms Select this option to ensure that all events are counted in the sub-
report.
Separate Diagnosis & Symptoms Select this option to include all SUSAR events in the CTR Report.
Print Unsubmitted This option allows a user to print MedWatch or VAERS forms for
U.S. cases. The following types of cases will be excluded:
• Foreign Cases (Country of Incidence not equal to U.S.)
• Clinical Trial Cases (Case Report type in list maintenance has
this type includes cases from clinical trials checked.)
• Literature Cases (Case Report type in list maintenance has
this type include case from literature checked.)
• Cases with submitted expedited reports to the Agency selected
in the CTPR.
When MedWatch is selected for PSUR, CTPR, and NDA, then the
Reporting Destination drop-down displays only those agencies that
has MedWatch profile (standard or custom) configured in the
Reports > Periodic Reports > NDA > Line
Listing > Print MedWatch > Forms of Agency
section.

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Field Description
Exclude Reports that are Non- Allows a user to suppress MedWatch or VAERS forms from printing
Serious and Listed for Non-Serious listed cases where all events are non-serious and
listed for the datasheet specified.
Use Periodic numbering on the Numbers the requested forms with a periodic format. (Namely,
Reports Periodic Page 1 - 1, Periodic Page 1 - 2, Periodic Page 2 - 1,
Periodic Page 2 - 2, etc.) An index with the Case Number is also
included.

Generate single case submission report

Use the following fields in the Single Case Submission Support section to generate the report.

Field Description
Generate Periodic ICSR submissions Select this checkbox to generate the ICSR Reports only for the
for cases that do not have at least one cases, where a Periodic ICSR Report for the message type
ICSR report scheduled during the chosen, does not exist.
reporting period to any of the Select one or more trading partners from the list box.
following Reporting Destination(s)
Important: Any case that does not have an expedited or single
case periodic submission to a trading partner, must have an
ICSR report scheduled as a part of the Periodic submission.
Modify Click Modify to select a different Reporting Destination.
Generate Periodic ICSR submissions Select a single-destination trading partner for Periodic Reports
to the following Reporting Destination from the drop-down list box.
Using the Message Type Select the required message type from the drop-down list box

Select summary listing

The UD Summaries tab allows you to specify which summary listings will appear along with the
line listing.

Field Description
Include these summary tabulations/ Allows you to select from pre-configured summary tabulations/
listings based on the set of cases listings based on Case Data Analysis, Case listing or CIOMS II
presented in the line listing line listing reports. These tabulations are based only on the
data included in the line listing. Select the Exclude Follow-up
Cases checkbox to filter out follow-up cases from the attached
report.
If the Exclude Follow-up Cases option is selected on the
Inclusion criteria tab, this option is ignored and follow-up cases
are always filtered out.
Include these summary tabulations Allows for additional sub-reports based on the Case Data
based on all cases Analysis template, to be included as an output for the all
cases in the database that meet the CTPR inclusion criterion
for all dates.

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Field Description
Include these summary tabulations/ This option allows for additional sub-reports based on Case
listings based on the Date Range Data Analysis, Case listing or CIOMS II line listing reports to
be included as an output for the cases meeting the CTPR
inclusion criterion for the Date Range specified when adding
the sub-report.
The dates are based on either the Case Creation Date or the
Initial Receipt Date as entered on the CTPR Inclusion Criteria
tab. Check the checkbox to the right of the sub-report to ignore
considering follow-up cases for the sub-report.

Schedule the report

The Scheduling tab enables you to specify details of how often the periodic report will be
scheduled.

Field Description
Start Date This is the International Birth Date for the PSUR product. This date is
computed as the earliest Awarded date for any license of any type.
Recalculate Allows a user to recompute the International Birth Date of the PSUR Product.
This date can be overwritten/manually entered, if needed.
Report is due xx days Enter the number of days when the report will be due after the end date
after specified end date specified for the scheduling period.
Automatically generate Allows a user to specify the timing of the automatic report generation, by
report xx days before/ specifying the number of days before/after the selected end date of the report.
after selected end date
at xx:xx
Group Allows the user to select the group to which the automatically generated report
is to be assigned.

Setup frequency of the scheduled reports

Field Description
Frequency Allows a user to specify the interval required for this scheduling period.

Configure security level of the report

The Security tab is used to configure the security level for the PSUR.

Field Description
Share this Report with Click this checkbox to share this report with other users. Specify the privileges
Other Users to be granted to groups by adding the group name from the Users Groups list
to either the Execute or Modify and Execute list. A user group can exist in
only one of these access lists.
User Groups The groups listed here have no access to the PSUR report template. Click Add
or Remove to move them to another access list.
Execute The groups listed here have read and execute access to the shared PSUR
report template.

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Field Description
Modify & Execute The groups listed here have read, execute and modify access to the shared
PSUR report template.

Use report templates

Refer to the Oracle Argus Dossier User's Guide for description of fields in the Templates tab.

Prepare content for an ICH PSUR

The Periodic Safety Update Reports (PSURs) are created on a periodic basis to enable
regulatory authorities to monitor the safety of a marketed product. This information is used to
view new data about the product acquired from appropriate sources. It helps relate this data to
the patient exposure and also indicates whether changes should be made to the product
information in order to optimize the use of the product. Requirements on the due date of
periodic reports may differ for different regulatory authorities.
For more information, see:
• Create Periodic Safety Update Reports (PSURs)
• Enter common fields information
• Configure subject in the report header
• Select products to include in ICH PSUR
• Select inclusion criteria
• Include line listing
• Add data elements
• View selected data elements
• Group cases
• Specify summary tabulations for line listing
• Include CIOMS reports
• Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials
• Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-
Marketing Data Sources
• Add cumulative summary
• Add FDA PSUR support information
• Generate single case submission report
• Select summary listing
• Schedule the report
• Setup frequency of the scheduled reports
• Configure security level of the report
• Use report templates

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Create Periodic Safety Update Reports (PSURs)

1. Select Reports, then select Periodic, and click ICH PSUR Reports. A list of PSUR
Reports opens in the right frame.
2. Click Copy or Modify to create a new report from an existing report.
OR
Click New Report to create an entirely new report.
3. When the system opens the ICH PSUR Line Listing Reports dialog box, enter an
appropriate report name in the Report Name field.
Use the tabs to configure the PSUR.

Enter common fields information

See Enter common fields information.

Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency,
products, etc. for which the PSUR will be applicable.

Field Description
Primary Agency Select the Primary Agency.
Reporting Destination Displays the list of agencies from where the report is being sent. Select an
agency from the list displayed in Reporting Destination and click Add to add
the report to the Selected Destination list.
You can select multiple agencies from the list of agencies such that the report
can be submitted to multiple agencies at the same time.
Likewise, select a report from the Selected Destination list and click Remove
to prevent it from being sent to the selected destination.
Selected Destination Displays the list of agencies where the report is being sent. Select an agency
from the list displayed in Reporting Destination and click Add to add the
report to the Selected Destination list.
You can select multiple agencies from the list of agencies such that the report
can be submitted to multiple agencies at the same time.
Likewise, select a report from the Selected Destination list and click Remove
to prevent it from being sent to the selected destination.
Ingredient Automatically displays the Ingredient as provided in the Subject of Report
dialog box.
You can choose whether to view these field or not. Check the checkbox
displayed with this field to hide or view it.
Trade Name Automatically displays the Trade Name(s) as provided in the Subject of Report
dialog box. Multiple trade names are also displayed together, separated by
commas.
You can choose whether to view this field or not. Check the checkbox
displayed with this field to hide or view it.
International Birth Date Automatically displays the earliest license awarded date, when a user selects
an Ingredient and a Product.
You can choose whether to view this field or not. Check the checkbox
displayed with this field to hide or view it.

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Field Description
Print all configuration Mark this box to print out the configuration of this report when the report is
criteria on separate printed. This is only available when PDF option is selected during printing.
cover page
Print page numbers on When checked, this option enables the user to print page numbers on a
reports periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.
• The Include Periodic Page Numbering on CIOMS reports option on the
PSUR Summary Tabulations CIOMS Reports section is grayed out and
inactive.
• The Use Periodic Numbering on the reports option in PSUR Summary
Tabulations FDA PSUR section is grayed out and inactive.
• The Additional Separate Page Numbering for UD Summaries in the
PSUR UD Summaries tab is grayed out and inactive.
• The system removes all existing report page numbering and the option to
check page number checkboxes on the report configuration tabs are
grayed out and inactive.
Allow access to report When the report is run as final, it creates a Hit List, which can be retrieved
cases through Hit List from other areas of the application where advanced conditions can be
selected. Click this checkbox to report cases through the Hit List.

Select products to include in ICH PSUR

Field Description
Available Ingredients Displays the list containing the Ingredients used for the product configuration.
Select an ingredient from the list displayed in Available Ingredients and click
Add/Remove to add or remove the ingredient.
You can select multiple ingredients at a time.
Indication This list contains the Indication configured for the product containing the
ingredients in the Available Ingredients section. The selections made from
this list get displayed in the Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL
key and clicking the different Indication entities.
Formulation This list contains the Formulation configured for the product containing the
ingredients in the Available Ingredients section. The selections made from
this list get displayed in the Selected Products section.
You can select multiple Indications from the list at a time by pressing the CTRL
key and clicking the different Indication entities.
Available Products This list is automatically populated with the selections made in the Indication
section.
Selected Products This list contains products selected by the user from the Available Products
list. When a product is selected, the Trade Name field and International Birth
Date fields are auto-populated with the license trade name (formulation,
concentration) and earliest License Award Date for the product.

Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a
periodic report. The top section of the dialog box allows you to specify the type of cases that
are to be included in the periodic report.

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Inclusion criteria of the reports considers listedness of all blinded products configured in the
study and present in the case while still being in the blinded state. Such blinded products are
included in the periodic report when event-level listedness is considered.
Click Add to add a criterion. Select appropriate items from the list of items that appear.

Field Description
Use Assessments in When selected, the PSUR Report will use the Case Event Assessment when
Cases performing datasheet listedness calculations.
Re-assess cases When selected, the PSUR will re-assess the cases in the line listing based on
against datasheet in the Active Datasheet on or before the Start Date of the Reporting period.
effect at the beginning
Re-assess cases When selected, the PSUR will re-assess the case in the line listing based on
against datasheet in the Active Datasheets on or closest to the end date of the PSUR Reporting
effect at end end date range without exceeding that date.
Expeditable Only This checkbox is available only when an agency is selected in the Subject of
Report tab. If you check this checkbox, only the cases classified as submitted
expedited reports to the specified agency are used.
Exclude Follow-up Filters out follow-up Reports from the PSUR Line Listing Report.
Cases
Include Unlocked Allows you to include unlocked cases in the periodic report.
Cases
Advanced Condition Allows you to specify an advanced condition that must be satisfied by each
case that is included in the report. Ensure that the advanced condition or the
advanced condition query set that is specified here does not contradict any
other criteria specified in the dialog box.
Use Datasheet Allows you to select datasheet for a report to make UDF tabulations.
Assessment for UDF If no datasheet is selected, the most conservative listedness is chosen.
Tabulations Namely, Unlisted followed by Listed.
Add Cases not included Allows you to add cases which were not included in the previous reporting
in previous reporting period.
period You can enter the start date of the period in the Start Date field.
Dropdown list Select the appropriate report type from the drop-down list.
Datasheet This list allows you to specify which datasheet is to be checked to determine
the listedness (listed or unlisted) of the case.
Serious/Non-Serious If you select Serious and clear Non-serious, only cases having a serious
event are included and vice-versa. If you select both Serious and Non-
Serious the seriousness criteria is ignored.
Fatal/Non-Fatal Select Fatal when at least one event has an event outcome of Fatal. If not,
select Non-Fatal. If you select both Fatal and Non-Fatal, both types of cases
are included.
Listed/Unlisted Select Listed to view only Listedness values. If you select both Listed and
Unlisted, all Listedness values (including Unknown) are included.
Related/Non-Related Relatedness refers to the more conservative of reported or company causality.
Select Related for any reportable causality type, and Non-Related for any
non-reportable causality type.
HCP/Non-HCP HCP refers to cases that identify a Health Care Professional in the Reporter
section within the General tab of the Case Form.
Primary Reporter Only This checkbox displays whether the Primary Reporter has been selected to
determine the HCP status.

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Include line listing

Field Description
Include Line Listing Allows you to select whether you want the Line Listing Data Elements printed
with the PSUR Report.
From the Available Data Elements, select As determined listedness to print
listedness.
For Blinded clinical trial cases, when the Include datasheet/licenses for all
the blinded study products common profile switch is checked, then
listedness is printed against the default study product.

Add data elements

• Select the checkbox displayed against each data element to add it to the report.
• The unavailable fields are printed on the report by default and cannot be changed.

View selected data elements

This section lists the selected elements and enables you to arrange the order in which these
are to be printed.

Field Description
MedDRA Hierarchy Select cases to populate the data from the case data. Select Dictionary to
from Cases/Dictionary populate the data from the MedDRA dictionary.
Print Only the Term Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as
(Preferred Term or per the selected radio button. Select the PT option to print only the preferred
Lower Level Term) term and not the verbatim description.
Print Dose Text in place Prints the dosage and frequency information from Dose Description field
of regimen dose instead of Regimen Dose.
Indicate if case was This checkbox is selected if an agency has been selected in the Subject of
expedited previously Report tab. Cases for which an expedited report was previously submitted to
the selected authority are marked with an asterisk and the date of submission
appears in the line listing.
Any case that has been previously expedited to a selected agency, is listed in
the list of Agencies in the Subject of Reports tab.
English Language Provides the option to print the descriptions in English.
Local Language Allows a user to specify which local language for a multi-language field is to be
printed - namely, the Abbreviated Narrative field.
Print event info Check this checkbox to print the Seriousness, Listedness and Causality
(Serious, Un-listed, under the Event Verbatim column.
Related) as Column Events having listedness of 'Unknown' are considered Unlisted. If only
diagnoses are assessed for event assessment, the events which are
associated with a diagnosis but have been marked with Diagnosis as 'No'
display '-' for both listedness and causality.
List cases only once, Select this option to view the details of cases in the Main Line Listing only
under the primary event once under the Primary Event.

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Field Description
List cases under all Select this option to view the details of cases in the Main Line Listing only
events, details under once under the Primary Event, while non-primary events are listed under their
the primary event respective event hierarchy with a reference to the primary event body system.
Therefore, use this option when grouping on Main Line Listing is by the Event
Body System.
Print Product Indication Enables you to print the product indication for the product selected in the
for the Product selected report.
in the Report

Group cases

Field Description
Available Groupings Allows a user to group cases together from the given list. Select the desired
groupings from the list and click Add to move the grouping to the Selected
Groupings list.
Selected Groupings Lists the added groupings, and reports the groups in the order they were
selected. Up to 5 grouping options can be selected from the Available
Groupings list.
Available Sortings Allows a user to sort cases together from the given list. Select the desired
sortings from the list and click Add to move the sorting to the Selected
Sortings list.
Selected Sortings Allows a user to further sort cases without a total count for each sorted item.
Up to 3 sorting options can be selected from the Available Sortings list. This
list is populated with the Mandatory Line Listing entities plus any optional data
elements chosen for this configuration.

Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/listings will
appear along with the line listing. The system enables you to separate the cumulative summary
by seriousness, relatedness, and listedness. If you choose this option, the system separates
the product event detail into the following categories: Serious/Non-Serious, Related/Non-
Related, and Unlisted/Listed events.

Field Description
Include Index of Cases Create an index page of case numbers, for all cases included in the PSUR.
in PSUR

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Field Description
Include Summary of This option creates a sub-report of cases missing one of the following items:
Cases Missing • Seriousness
Assessments • Case Causality
• Case Listedness
• Case Outcome
• Event Causality
• Event Listedness
Click this checkbox to create one or both of the following sub reports:
Cases Missing Assessments - This sub-report displays cases that have
been included in the PSUR line listing, but one or more of the following have
not been assessed:
• Case Seriousness
• Case Causality
• Case Listedness
• Case Outcome
• Event Causality
• Event Listedness
Cases Not Included in Report - This sub-report displays cases that have not
been included in the PSUR line listing as a result of missing one or more of the
following items:
• Lock Status
• Safety Date
• Uncoded Event
• Causality
Include Line Listing Check this checkbox to view a pre-defined summary tabulation of Report type,
Tabulation Seriousness and Listedness of all cases in the PSUR.
Additional Expedited Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its
Report Forms (CIOMS/ respective regulatory agency (as selection), for all cases in the report. It also
MedWatch/VAERS) provides an option to have (or not have) a watermark in the forms.

Include CIOMS reports

Field Description
Print CIOMS reports for Allows a user to print CIOMS I forms for all Serious/Unlisted (Case Level)
serious/unlisted cases cases appearing in the PSUR.
CIOMS contain Internal or Other text printed on them when the PSUR is
printed using the Internal or Other option.
Include Periodic Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1 of 2,
Numbering on the A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to also contain the
CIOMS reports Periodic paging of each CIOMS report.

Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical
trials

Field Description
Include Section 6.2 Check this checkbox to include Section 6.2. By default, this is unchecked.

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Field Description
Cumulative Start Date Enter the cumulative start date in this field. This field specifies the Start Date
of the Cumulative date range. If not specified, the start date is picked from
the date specified in the Inclusion Criteria. If specified, the application
ensures that the date entered is a valid date, and is before the Start Date
specified in the Inclusion Criteria.
Identify Study Cases Allows you to select the study cases that use report type from the multi-
using Report Type select list box. The values that are populated here, come from the Report
Type codelist where the values display the This type includes cases from
clinical trials as checked.
Group by Comparator If the Product Type attribute is present in the Study Configuration for the
Product being evaluated, this option is displayed. By default, this is
unchecked. If this checkbox is selected, it displays sub columns based on
Active Comparator names if Group by Comparator is selected. If Group by
Comparator is not selected, the count is displayed under the name of the
respective active comparator.

PBRER 6.2 Output for the non-company or non-configured study cases is fetched based on
the following:
• When the case being evaluated is a non-company or non-configured study case, the
suspect company products are printed with the product type as Medicinal Product.
The name of the medicinal product(s) is printed along with the counts:
– If the case and the study are not blinded, and the product type is identified as
Investigational Product.
– If the case is unblinded (but the study is blinded), and the user has privilege to view
the unblinded data.
– If the study is blinded but the case is unblinded, and you do not have privilege to view
the unblinded data, the count is printed under Blinded.
• Counts for Active Comparator and Placebo are not expected for a non-company study
cases as the comparator or placebo information cannot be determined for the non-
company studies.Non-company study cases that do not have any company suspect
products are not included in the case series and cumulative tabulations.
• If counts for Blinded, Active Compactor and Placebo are Zero, these columns are still
displayed in the report with zero counts as the value.
• The report also prints SOCs with zero counts if there are no events reported.

Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-
Marketing Data Sources

Field Description
Include Section 6.3 Check this checkbox to include Section 6.3. By default, this is unchecked.
Cumulative Start Date Enter the cumulative start date in this field. This field users to specify the
Start Date of the Cumulative date range. If not specified, the start date is
picked from the date specified in the Inclusion Criteria. If specified, the
application ensures that the date entered is a valid date, and is before the
Start Date specified in the Inclusion Criteria.

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Field Description
Identify Spontaneous Allows you to select the study cases that use report type from the multi-
Cases using Report Type select list box. The values that are populated here, come from the Report
Type codelist where the values display the This type includes cases from
clinical trials as NOT checked. Only those values are included, where
Display is set to Yes, in order to be consistent with the Report.
Identify Non- This is a mandatory field, comprising three new rules to identify Non-
interventional Studies Interventional Studies: (Case Classification, Report Type, and Observe Study
(UNION of rules below) Type). These three new rules are displayed as checkboxes and have a
section label called Identify Non-interventional Studies (UNION of the
rules below).
This field is mandatory, which means that at least one of the options must be
selected if Include Section 6.3 is selected.
Along with the three options, there is a multi-select list box for each that is
populated with values from the respective codelist (given below) for the
corresponding option that the user selected:
• Case Classification is populated with values from Case Classification
codelist.
• Report Type is populated with values from Report Type codelist
• Observe Study Type is populated with values from Case Classification
codelist with ICSR code values that are not-null
All values are included in this list, irrespective of the Display field for Case
Classification and Observe Study Type codelists. Those values where
Display for Report Type codelist is set to Yes, are also included.
A + sign is displayed as a label, next to these options to indicate that it is a
UNION of selections.

Add cumulative summary

Field Description
Include Cumulative Select the checkbox to create a sub-report count of events, grouped by
Summary Product and Body System (SOC) and sorted by Preferred Term. The sub-
report contains a previous date range count of events (comparative date
range), a current date range count (current PSUR date range) and a
cumulative count (all dates) of events assessed against the product(s) of the
PSUR and matching the inclusion criteria.
Comparative Date Allows a user to specify the previous date range as a comparison date for the
Range events counted, and therefore should not overlap with the current date range
specified on the PSUR inclusion criteria tab.

Add FDA PSUR support information

The FDA PSUR Support section can be used if the company has obtained an FDA waiver to
submit a PSUR instead of an NDA report.

Field Description
Include Adverse Event Summary Select this option to generate a sub-report of events from the line
listing. This sub report is grouped by Body System and Preferred
Term.

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Field Description
Causality Select the desired causality from the list.
Ignore - Counts events regardless of causality assessment.
Causal - Counts events where the causality is considered
reportable in the Causality Category configuration in List
Maintenance.
Not Causal - Counts events where the causality is considered
non-reportable in the Causality Category configuration in List
Maintenance.
As Determined - Counts events where 'As Determined' causality
meets the above selected causality criteria.
As Reported - Counts events where 'As Reported' causality
meets the above selected causality criteria.
Both - Counts events where both 'As Reported' and 'As
Determined' causality meet the above causality criteria.
Either - Counts events where either the 'As Reported' or 'As
Determined' causality meets the causality criteria.
Only Cases with HCP Reporter Check this checkbox to include events for only those cases that
feature an HCP reporter.
Diagnosis Select this option to ensure that only events marked as diagnosis
are counted.
Diagnosis & Symptoms Select this option to ensure that all events are counted in the sub-
report.
Separate Diagnosis & Symptoms Select this option to include diagnosis and symptoms separately
in the sub-report. Selecting this option means that the case
numbers are separated by Diagnosis and Symptoms respectively.
Domestic Consumer Support Select this option to enable domestic consumer support.
Print Unsubmitted This option allows a user to print MedWatch or VAERS forms for
U.S. cases.
Exclude Reports that are Non- Allows a user to suppress MedWatch or VAERS forms from
Serious and Listed printing for Non-Serious listed cases where all events are non-
serious and listed for the datasheet specified.
Use Periodic numbering on the Numbers the requested forms with a periodic format. (Namely,
Reports Periodic Page 1 - 1, Periodic Page 1 - 2, Periodic Page 2 - 1,
Periodic Page 2 - 2, etc.) An index with the Case Number is also
included.

Generate single case submission report

Use the following fields in the Single Case Submission Support section to generate the
report.

Field Description
Generate Periodic ICSR submissions for cases Check this checkbox to generate the ICSR Reports only
that do not have at least one ICSR report for the cases, where a Periodic ICSR Report for the
scheduled during the reporting period to any of message type chosen, does not exist.
the following Reporting Destination(s) Select one or more trading partners from the list box.
Important: Any case that does not have an expedited
or single case periodic submission to a trading partner,
must have an ICSR report scheduled as a part of the
Periodic submission.

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Field Description
Modify Click Modify to select a different Reporting Destination.
Generate Periodic ICSR submissions to the Select a single-destination trading partner for Periodic
following Reporting Destination Reports from the drop-down list box.
Using the Message Type Select the required message type from the drop-down
list box

Select summary listing

The UD Summaries tab allows you to specify which summary listings will appear along with the
line listing.

Field Description
Include these summary Allows you to select from pre-configured summary tabulations/listings. These
tabulations/listings tabulations are based only on the data included in the line listing. Selecting the
based on the set of Exclude Follow-up Cases checkbox filters out follow-up cases from the
cases presented in the attached report.
line listing If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab,
this option is ignored and follow-up cases are always filtered out.
Include these summary Allows for additional sub-reports based on the Case Data Analysis template,
tabulations based on all to be included as an output for the all cases in the database that meet the
cases PSUR inclusion criterion for all dates.
Include these summary This option allows for additional sub-reports based on Case Data Analysis,
tabulations/listings Case listing or CIOMS II line listing reports to be included as an output for the
based on the Date cases meeting the PSUR inclusion criterion for the Date Range specified when
Range adding the sub-report.
The dates are based on either the Case Creation Date or the Initial Receipt
Date as entered on the PSUR Inclusion Criteria tab. Check the checkbox to
the right of the sub-report to ignore considering follow-up cases for the sub-
report.
Identify SUSAR and Enables you to identify any SUSAR and special interest events.
Special Interest Events
Additional Separate Enables you to include additional separate page numbering for summaries.
Page Numbering for UD
Summaries (PDF only)

Schedule the report

See Schedule the report.

Setup frequency of the scheduled reports

See Setup frequency of the scheduled reports.

Configure security level of the report

See Configure security level of the report.

Use report templates

Refer to the Oracle Argus Dossier User's Guide for a description of fields in the Templates tab.

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Prepare content for a US IND periodic report

The system enables you to define an IND summary report. You can add a new report as well
as copy, modify and delete existing reports.
For more information, see:
• Create new IND report
• Enter common fields information
• Configure subject in the report header
• Select products to generate the report
• Select inclusion criteria
• Include line listing
• Specify summary tabulations for line listing
• Schedule the report
• Configure security level of the report

Create new IND report

1. Select Reports, then Periodic Reports, and click IND to open IND Subject of Report view.
2. Click New Report.
OR
Select an existing report from the list and click Copy or Modify.
3. When you click New Report, the IND Line Listing Reports dialog box opens.
4. Enter an appropriate name for the report under Report Name.
5. Use the tabs in this dialog box to configure the IND Report.
6. From each tab in the IND Summary Report, you can choose to Print all configuration
criteria on separate cover pages (PDF Only).

Enter common fields information

See Enter common fields information.

Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency,
products, and other elements. Select multiple ingredients for a configured IND Report to view
the multiple licenses to be selected for the report.

Field Description
Primary Agency Select the Primary Agency.
Available Reporting Destinations Displays the list of configured Regulatory Agencies. Select an agency
from the list displayed in Reporting Destination and click Add to add
the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click
them.

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Field Description
Selected Reporting Destinations Displays the list of agencies where the report is being sent. Select an
agency from the list displayed in Reporting Destination and click
Add to add the report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click
them.
Likewise, select an agency from the Selected Destination list and
click Remove to prevent it from being sent to the selected destination.
Company Name If a regulatory agency is selected in the Subject of Report tab, then
the company name associated with the regulatory agency (this
association is created by the Administrator) is automatically entered in
this field.
Product Name This field is automatically filled as per the Ingredient field.
Check the checkbox corresponding to this field to choose whether you
want this field to appear on the report.
Approval This field is automatically filled with License numbers, separated by
commas. This is an editable field.
Award Date This field is populated with the earliest awarded Investigational
License for US amongst the licenses selected. This field cannot be
edited.
Check the checkbox corresponding to this field to choose whether you
want this field to appear on the report.
Print all configuration criteria on Click this checkbox to print out the configuration of this report when
separate cover page the report is printed. This is only available when the PDF option is
selected during printing.
Print page numbers on reports When checked, this option enables the user to print page numbers on
a periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.
• The Additional Separate Page Numbering for UD Summaries
option on the IND Summaries Tabulation tab is grayed out and
inactive.
• The system removes all existing report page numbering.
Allow access to report cases When the report is run as final, it creates a Hit List, which can be
through Hit List retrieved from other areas of the application where advanced
conditions can be selected. Click this checkbox to report cases
through the Hit List.

Select products to generate the report

Use the Product Selection tab to select product information to include in the report.

Field Description
Available Ingredients Displays the list containing the Ingredients used for the product configuration.
Select an ingredient from the list displayed in Available Ingredients and click
Add/Remove to add/remove the ingredient.
You can select multiple ingredients at a time.
Filter Enter an Ingredient name and click Filter to search for the entered ingredient
within the Available list of Ingredients.
Selected Ingredients Displays the list of ingredients selected from the Available Ingredients list.

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Field Description
Indication This list contains a list of all the indications for the products containing the
selected ingredient. The selections made from this list are displayed in the
Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL
key and clicking the different Indication entities.
Formulation This list contains the Formulations configured for the product containing the
selected ingredient and indication. The selections made from this list get
displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the
CTRL key and clicking the different Indication entities.
Available Licenses This list is automatically populated with the licenses from the Indication
section.
Selected Licenses This list contains licenses selected by the user from the Available Licenses
list. When a product is selected, the Trade Name and International Birth
Date fields are auto-populated with the license trade name (formulation,
concentration) and earliest License Award Date for the product.

Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a
periodic report.

Field Description
Case Creation Date Allows you to specify a range of cases by the date when the case was created.
Case Receipt Date Allows you to specify a range of cases by the initial receipt date.
Use Current Version Allows you to use the latest revision to populate the data within the selected
reports.
Use DLP Version Allows you to use the case data of the version as of the specified DLP Version.
Age Groups Allows you to include or exclude cases based on the patient's age group.
Select the Age Groups checkbox to activate the age groups and select all the
age group categories that apply.
Options - Domestic/ This option allows the user to include domestic and foreign cases within the
Foreign Cases periodic report. Select Domestic if Country of Incidence is USA and Foreign
if Country of Incidence is not USA.
Expeditable Only This checkbox is available only when an agency is selected in the Subject of
Report tab. If you check this checkbox, only the cases classified as submitted
expedited reports to the primary agency are used.
Include Unlocked Allows you to include unlocked cases in the periodic report.
Cases
Advanced Condition Allows you to specify an advanced condition that must be satisfied by each
case that is included in the report. Ensure that the advanced condition or the
advanced condition query set that is specified here does not contradict any
other criteria specified in the dialog box.

Include line listing

Field Description
Report All Events Select this option to report all events.

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Field Description
Report only Diagnosis Select this option to report only diagnosis events (only the diagnosis events
Events that are either explicitly marked as diagnosis or are non-related symptoms).
List cases only once, Select this option to view the details of cases in the Main Line Listing only
under the primary event once under the Primary Event.
System Organ
Class(SOC)
List cases under all Select this option to view the details of cases in the Main Line Listing only
event System Organ once under the Primary Event, while non-primary events are listed under their
Class (SOC) respective event hierarchy with a reference to the primary event body system.
Therefore, use this option when grouping on Main Line Listing is by the Event
Body System.
Create a Sub Report for Check this checkbox to separate death cases from the main IND listing. If the
Death Cases checkbox is checked, all death cases (Identified by any event marked as death
in Seriousness Criteria or any event having an Event Outcome as Death) are
filtered out from the IND Line Listing. All death case show up in a sub report,
called IND Line Listing (Death Cases).

Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations will appear
along with the line listing.

Field Description
Include these summary Allows you to select from pre-configured summary tabulations/listings. These
tabulations/listings tabulations are based only on the data included in the line listing. Select the
based on the set of Exclude Follow-up Cases checkbox to filter out follow-up cases from the
cases presented in the attached report.
line listing If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab,
this option is ignored and follow-up cases are always filtered out.
Include these summary Allows for additional sub-reports based on the Case Data Analysis template,
tabulations based on all to be included as an output for the all cases in the database that meet the IND
cases Report inclusion criterion for all dates.
Add Displays a list of memorized Case Data Analysis Reports that have been
marked for availability in a periodic report.
Remove Click this button to remove a selected report.
Additional Separate Enables you to include additional separate page numbering for summaries.
Page Numbering for UD
Summaries
Include Summary of Enables you to print the list of Case Numbers that are included in the Periodic
Unlocked Cases Reports but are not locked.

Schedule the report

See Schedule the report.

Configure security level of the report

See Configure security level of the report.

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Prepare content for an NDA periodic report

The NDA Periodic Reports enable you to define an NDA Periodic report. You can add a new
report as well as copy, modify and delete existing reports.
• You can print an Index of Cases included in the NDA report.
• If you select this option, the system lists the cases from the following sections once at the
end of the configuration pages:
– Sequential List of cases
– Serious Listed Initial/Follow up
– Non Serious Listed Initial/Follow up
– Non Serious Unlisted Initial/Follow up
– 15 Day Submission
• The page numbering for this sub-report continues from the configuration pages.
• You can separate initial case events from follow-up case events in the Summary Tabulation
tab of the NDA Report.
– If you select this option, the system counts events in the Initial section if the case is in
the Serious Listed, Non-Serious Listed, or Non-Serious Listed/Unlisted sections.
– If you select this option, the system counts events in the Follow-up section if the case
is in the Serious Listed or Non-Serious Listed/Unlisted follow-up sections of the NDA
report.
– For the 15 Day events, if the case has not been previously reported in a NDA, the
system counts it in the Initial section then the Follow-up section.
– If you select List cases once under the Primary Event System Organ Class (SOC), the
system displays a footnote with an asterisk ( * ) printed across all the System Organ
Classes on the report and the following statement: Primary Event System Organ
Class.
• If you select the Print FDA-3500A/VAERS form at the end option, the system prints the
report sections in the following order:
– Configuration (Including Case Indices (e.g. Sequential Case Listing, Listing by
Seriousness/Listedness, Listing of Cases Missing Analysis)):
* Line Listing
* Summary Tabulations
* MedWatch/VAERS reports at the end of the report
– Page numbering for the MedWatch reports continue from the last page of the NDA
report.
– The configuration pages have been updated to reflect the updates made to the NDA
Reports.
– The configuration pages are printed at the beginning of the NDA report.
– By default, these are unchecked on all the existing configured reports.
• Create NDA summary report
• Enter common fields information
• Configure subject in the report header

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• Select products to generate the report

• Select inclusion criteria
• Include line listing
• Specify summary tabulations for line listing
• Schedule the report
• Configure security level of the report

Create NDA summary report

1. Go to Reports, then select Periodic Reports, and click NDA Reports to open the NDA
Subject of Report view.
2. Click New Report to create an entirely new report,
OR
Select an existing report from the list and click Copy or Modify.
3. When you click New Report, the NDA Line Listing Reports dialog box opens.
4. Enter an appropriate report name in the Report Name field.
5. Use the tabs in this dialog box to configure the NDA Report.
6. From each tab in the NDA Report, you can choose to Print all configuration criteria on
separate cover pages (PDF Only).

Enter common fields information

See Enter common fields information.

Configure subject in the report header

On the Subject of Report tab you can select multiple Ingredients for a configured NDA Report
per allowable variations of product and license configuration and periodic reporting
requirements for the FDA. Select multiple ingredients to view the multiple licenses to be
selected for the report.

Field Description
Available Reporting Displays the list of configured Regulatory Agencies. Select an agency from the
Destinations list displayed in Reporting Destination and click Add to add the report to the
Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.
Selected Reporting Displays the list of agencies where the report is being sent. Select an agency
Destinations from the list displayed in Reporting Destination and click Add to add the
report to the Selected Destination list.
Select multiple agencies by holding the CTRL key when you click them.
Likewise, select an agency from the Selected Destination list and click
Remove to prevent it from being sent to the selected destination.
Company Name If a regulatory agency is selected, the company name associated with the
regulatory agency (this association is created by the Administrator) is
automatically entered in this field.

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Field Description
Ingredient This field is populated with ingredient selected in the Subject of Report tab.
Check the checkbox corresponding to this field to choose whether you want
this field to appear on the report.
Approval This field is automatically filled with License numbers, separated by commas.
This is an editable field.
Trade Name Automatically displays the Trade Name.
Multiple trade names are also populated from license trade name (formulation,
concentration) of selected licenses, separated by commas.
Check the checkbox corresponding to this field to choose whether you want
this field to appear on the report.
Award Date Automatically displays the earliest license awarded date, when a user selects
an Ingredient and a Product.
Check the checkbox corresponding to this field to choose whether you want
this field to appear on the report.
Print all configuration Click this checkbox to print out the configuration of this report when the report
criteria on separate is printed. This is only available when the PDF option is selected during
cover page printing.
Print page numbers on When checked, this option enables the user to print page numbers on a
reports periodic report. This is the default for all report configurations.
If this checkbox is not checked, the following occur.
• The Use Periodic Numbering on the reports option in the NDA Line
Listing tab is grayed out and inactive.
• The Additional Separate Page Numbering for UD Summaries in the
NDA Summary Tabulations tab is grayed out and inactive.
• The system removes all existing report page numbering and the option to
check page number checkboxes on the report configuration tabs are
grayed out and inactive.
Allow access to report When the report is run as final, it creates a Hit List, which can be retrieved
cases through Hit List from other areas of the application where advanced conditions can be
selected. Click this checkbox to report cases through the Hit List.

Select products to generate the report

The Product Selection tab enables you to select product information to include on the report.

Field Description
Available Ingredients Displays the list containing the Ingredients used for the product configuration.
Select an ingredient from the list displayed in Available Ingredients and click
Add/Remove to add or remove the ingredient.
You can select multiple ingredients at a time.
Filter Enter an Ingredient name and click Filter to search for the entered ingredient
within the Available list of Ingredients.
Selected Ingredients Displays the list of ingredients selected from the Available Ingredients list.
Indication This list contains a list of all the indications for the products containing the
selected ingredient. The selections made from this list are displayed in the
Available Products section.
You can select multiple Indications from the list at a time by pressing the CTRL
key and clicking the different Indication entities.

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Field Description
Formulation This list contains the Formulations configured for the product containing the
selected ingredient and indication. The selections made from this list get
displayed in the Selected Products section.
You can select multiple Formulations from the list at a time by pressing the
CTRL key and clicking the different Indication entities.
Available Licenses This list is automatically populated with the licenses from the Indication
section.
Selected Licenses This list contains licenses selected by the user from the Available Licenses
list. When a product is selected, the Trade Name and Award Date fields are
auto-populated with the license trade name (formulation, concentration) and
earliest License Award Date for the product.

Select inclusion criteria

Field Description
Case Creation Date Allows you to specify a range of cases by the date when the case was created.
Case Receipt Date Allows you to specify a range of cases by the initial receipt date.
Use Current Version Allows you to use the latest revision to populate the data within the selected
reports.
Use DLP Version Allows you to use the case data of the version as of the specified DLP Version.
Age Groups Allows you to include or exclude cases based on the patient's age group.
Select the Age Groups checkbox to activate the age groups and select all the
age group categories that apply.
Option (Applicable to This option allows the user to include domestic and foreign cases within the
Non-15-Day Selection periodic report. Select Domestic if Country of Incidence is USA and Foreign if
Only)- Domestic/ Country of Incidence is not USA.
Foreign Cases
Option (Applicable to This option allows the user to exclude Literature and Study Cases from being
Non-15-Day Selection considered for the NDA Report. Select Exclude Literature Cases to exclude
Only)- literature cases and select Exclude Study Cases to exclude study cases.
Exclude Literature
Cases/Study Cases
Advanced Condition Allows you to specify an advanced condition that must be satisfied by each
case that is included in the report. Ensure that the advanced condition or the
advanced condition query set that is specified here does not contradict any
other criteria specified in the dialog box.
Add Cases not Included Enter the start date. This adds cases not included in a previous reporting
in a previous reporting period with the specified start date.
period Start Date
Include Unlocked Allows you to include unlocked cases in the periodic report.
Cases
Evaluate Primary Allows you to select only the Primary Suspect Drug.
Suspect Drug Only

Include line listing

The NDA report comprises of three tabs. The options for these tabs can be configured in the
Line Listing tab.

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Field Description
Tab 1: FDA - 3500/ Check this checkbox to generate the MedWatch 3500A (Drug) or VAERS
VAERS Forms reports which are serious listed or non-serious.
Suppress printing of Check this checkbox to prevent printing the non-serious listed reports but print
non-serious listed their case numbers in the main NDA report indices.
reports Tab 1 of the NDA Line Listing report cannot be generated without Tab 2.
However, Tab 2 can be generated without Tab 1.
Tab 2: Index of Check this checkbox to generate an index of the forms from Tab 1. It prints all
Submitted Forms in Tab MedWatch/VAERS forms for the following cases:
1 • Serious Listed
• Non-Serious Unlisted
• Non-Serious Listed
Previously expedited 15-day reports that are Serious and Unlisted that have
already been submitted to the FDA do not need to be re-submitted with this
periodic report.
Tab 3 Part 1: NDA Line Check this checkbox to generate a list of all serious unlisted expedited reports
Listing of 15 Day within the specified time period.
Reports Submitted The dates in these reports are in GMT.
TAB 3 Part 2: Tabulation Check this checkbox to generate a tabulation by System Organ Class (SOC) of
by System Organ Class all events reported during the specified time period. This includes the cases for
(SOC) of All Event which expedited reports were previously generated, as well as the cases that
Reports Submitted are submitted as part of the current report.
TAB 3 Part 3: Cases Check this checkbox to print a list of all the serious unlisted events for which
sent to FDA under reports were submitted to the FDA previously.
another NDA

Note:
If you select to print out the Tab 3 Part 3 section,
the NDA report looks for other submissions (E2B,
MW, MW Drug, VAERS, eVAERS, eMDR) to the
same agency for the same case against other
(not included in selection criteria for this report)
marketed licenses. Any submission matching this
criterion is listed on the Tab 3 Part 3 section of
the NDA report. If there are multiple submissions
against different licenses, then each one is listed.
Each license is listed only once.

Include Periodic Check this checkbox to include all cases that have been sent under another
Submissions NDA.
Start Page Number Select the page number for the first page of the report.
Listing Options These options for List cases only once, under the primary event body
system and List cases under all events body systems only apply to the
NDA Line Listing of Expedited Reports Submitted report.
List cases only once, Select this option to list cases only once.
under the primary event
System Organ Class
List cases under all Select this option to list cases under each SOC for each event.
events System Organ
Classes

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Field Description
Include Summary of Check this checkbox to include a Summary of Cases missing Assessments at
Cases Missing the end of the report.
Assessments
Include Summary of Select this option to include a summary of unlocked cases.
Unlocked Cases
Include Listing of Any case that was deleted which has submitted report within the reporting
Nullified 15-day Alert period after an expedited submission was made to the FDA (primary agency)
Cases Submitted for the license specified in the NDA Periodic report, regardless of the report
During the Reporting form used, e.g., it could be MedWatch or Expedited E2B (E2Bs with
Period MESSAGETYPE tag value configured as Expedited in Message Type Code
List) or eVAERS.
Use Periodic numbering Select this option to use periodic numbering on reports.
on the Reports
Custom Case Summary Enter the Summary Report Title.
Tabulation
Advanced Condition Select the Advanced Condition from the drop-down list.

Specify summary tabulations for line listing

The Summary Tabulations tab allows you to specify which summary tabulations will appear
along with the line listing.

Field Description
Include these summary Allows you to select from pre-configured summary tabulations/listings. These
tabulations/listings tabulations are based only on the data included in the line listing. Select the
based on the set of Exclude Follow-up Cases checkbox to filter out follow-up cases from the
cases presented in the attached report.
line listing

Note:
If the Exclude Follow-up Cases option is selected
on the Inclusion criteria tab, this option is ignored
and follow-up cases are always filtered out.

Include these summary Allows for additional sub-reports based on the Case Data Analysis template,
tabulations based on all to be included as an output for the all cases in the database that meet the NDA
cases Report inclusion criterion for all dates.
Add Displays a list of memorized Case Data Analysis Reports that have been
marked for availability in a periodic report.
Remove Click this button to remove a selected report.
Additional Separate Enables you to include additional separate page numbering for summaries.
Page Numbering for UD
Summaries
Case Count Summary Enables you to print the list of Case Numbers that are included in the Periodic
Report Reports but are not locked.

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Schedule the report

See Schedule the report.

Configure security level of the report

See Configure security level of the report.

View scheduled periodic report information

In this section:
• Available user options
• View report details
• View report schedule details
• View report routing history

Available user options

Common features on the Period Reports page. Click the icon associated with each report to
view the following options:

Option Description
Description Displays the report name. Click this to open the selected report in PDF format.
Status Opens the Report Details dialog box for the selected report.
Print List Allows the user to print the current Periodic Reporting for referencing the
current view of the Periodic Reporting.
View Report Opens the Individual Periodic Report selected by the user.
Report Details Displays specific information about the report as entered in the Regulatory
Reports section.
The information displayed in the fields of the Report Details dialog box is
fetched from the data entered in the Regulatory Reports section of Case Form.

View report details

The Report Details > General tab displays the general information about the report.
The information on this tab cannot be modified.

Field Description
Agency Displays the Reporting Destination for which the report is scheduled.
Responsibility Displays the User Group to which the report is assigned.
Case Nullification Date Displays the date when the case was nullified.
Case Nullification Displays the reason entered when a case is logically deleted in Oracle Argus
Reason Safety.

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View report schedule details

The Scheduling tab displays a reason for scheduling this report. It also shows the date on
which the report was scheduled.
All fields in this tab are auto-populated as per records entered in Oracle Argus Safety.

View report routing history

The Routing tab displays the routing history of the report. To route the report, click Route.

Field Description
Group Displays the group of the report. This button is enabled when you click the Route
button.
User Displays the state of the report. This button is enabled when you click the Route
button.
Comments Displays routing comments entered before routing the report.

Submit a periodic report

In this section:
• Specify submission details
• Add comments
• Transmit a report
• View report generation status
• Create unscheduled periodic reports
• Approve and submit a report
• View submitted reports
• Use bulk report

Specify submission details

The Submission tab enables you to specify whether submission is required and enter a reason
for not submitting the report.

Field Description
Submission Required Enables you to select if this report is not required to be submitted to the
regulatory authority.
Reason for Non- Click Select to select the reason for non-submission.
Submission

Add comments
The Comment tab enables you to enter a local comment that prints out on that specific report
when generated. Each report has its own Local Comment section.

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Transmit a report
1. Click the icon associated with a report and select the Transmission tab from Report
Details. The Report Details dialog box opens.
2. Click OK or Cancel to approve the transmission or discard any changes, respectively.
3. Click the Transmit button to transmit a report. The Transmit to Recipients dialog box is
displayed.
4. Select the recipients of the report, as applicable from the Available Recipients list.
5. Select the method of transmission from Method, as applicable.
6. Enter remarks in Comments.
7. Click Transmit.
8. The selected report is transmitted to the specified recipients.

View report generation status

The Report Generation Status tab is displayed for users who have been configured by the
Oracle Argus Safety administrator in Argus Console, under Access Management > Groups
> Menu > Reports > Periodic Reports and for users who have access to the System
Library.

Field Description
Run At Date Displays the date and time when the report generation started.
For English users, it is displayed in DD-MMM-YYYY HH:MM:SS (GMT offset)
format.
For Japanese users, it is displayed in YYYY/MM/DD 00:00 (GMT offset) format

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Field Description
Status Displays the current status of report generation in the form of hyperlinks, with the
options listed below:
• Executing
• Error
• Pending
• Generated
On clicking the Generated status, the Periodic Report is displayed.
On selecting any status other than Generated, the Background Periodic Report
Execution Status dialog box is displayed, as shown below:

This dialog box displays the different stages of Periodic Report status. A grey tick
mark is denotes Pending state, a Green tick mark denotes Completed State, and
a Red cross mark denotes an Error.
Context Menu > View This option is displayed in the context menu only when PDF/CSV/DOCX Report
Report Creation is Generated. On clicking View Report, the selected report is displayed.
Applicable only for Periodic reports.

The Report Status screen displays the report outputs for the logged in user with the last report
run as the first report. The reports can be filtered using:
• Report Name
• Draft/Final
• Report Type
• Scheduled By
• Scheduled On
• Run At Date
• Status

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Create unscheduled periodic reports

1. Go to Reports, and select Compliance, then select Periodic, and click Create
Unscheduled Report.
2. The system opens Periodic Reports dialog box that provides a list of configured reports of
the following types:
• PSUR - Containing ICH PSUR Line Listing Reports
• IND - Containing US IND Periodic Reports
• NDA - Containing US NDA Periodic Reports
• CTPR - Containing CT Periodic Reports
3. Click the (+) icon against the desired category to view all the reports within that category.
4. Select the report you wish to create from this list and click Select.
5. When the system opens the Report Batch Printing dialog box, select Run Now or Run at,
as appropriate.

Note:
If you select Run Now, specify PDF, DOCX, or CSV from the drop-down list for
the report output option to generate the PSUR or CTPR report in the selected
format.
If you select Run at, specify the date/time to schedule the PSUR report to be
generated by Argus Safety Service. This enables only Final and disables all
other Print As options.

6. In the Email field, enter the email ID of the user to whom the periodic report should be
emailed, once completed. By default, this field lists the email address (if configured) of the
current user.
7. Select what you want printed on the report: Final, Draft, Internal, or enter Other
information.
8. Run Using allows users to select between Argus Native Periodic report and BI Publisher.
9. Report Form Type allows users to select the Report Templates and these options are
dependent on the value selected in Run Using. If Run Using is selected as Argus Native,
the Report Form Type drop-down list displays PBRER and PSUR. The option selected
from this drop-down list is used as Report Form Type for follow-up algorithm.
10. The options displayed in the Report Form Type are configurable through the flexible
codelist Report Template.
11. Click OK.

12. The system generates the periodic report.

Approve and submit a report

Before you can mark a report as submitted, the report must first be approved.
1. Open the case for which the report has to be approved.
2. Open the Regulatory Reports tab in the Case Form.

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3. When the system opens the Regulatory Reports details for the selected case, click the icon
associated with the report you wish to approve.
4. Select View Report Details.

Note:
The Case Nullification Date is the date when the case is deleted, the Case
Nullification Reason is the comment entered when the case is logically deleted in
Argus.

5. Select Submitted from the State list in the Routing tab and click Route.
6. When the system opens a dialog box, enter the required details and click OK.
7. The report is approved.

Note:
A user who has Workflow Manager rights can undo the submission of a report, if
necessary.

View submitted reports

1. Go to Reports, then select Compliance, and click Submitted Reports.
2. When the system opens the Submitted Reports page, enter the appropriate search criteria
and click Search. The system displays the Search Results.
Submitted reports—fields and field descriptions

Field Description
Case ID Enter the specific case number.
Tip: Use wild cards such as 2007% to search for cases starting with 2007.
Include these Select the required report type or case status to be displayed.
Reports
Product Select the product as required. The reports scheduled for these products will be
displayed.

Use bulk report

Bulk Reporting enables you to print, transmit or submit reports in bulk. Go to Reports, and
then select Bulk Reporting to view the Bulk Report screen.
The system displays the screen.
For more information, see:
• Filter bulk reports
• View bulk report filter results
• Print reports in bulk

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• Sort cases
• Lock state icon options

Filter bulk reports

The Bulk Reporting Filter section enables you to filter reports.

Field Description
Destination 1. To filter reports by agency, select an Agency.
The agencies that have reports in the Scheduled, Approved and
Generated states are displayed.
2. Click Filter to select multiple agencies from the Reporting Destinations
dialog box.
The previous filtering criteria is saved and retained when the user invokes
this dialog box. By default, all agencies are displayed.

Report Status From the drop-down list, select one of the options:
• Generated Only—Displays the reports that have been generated
(Generated, Approved, Disapproved and New Data Available states)
• Scheduled/Generated—Retains the existing behavior as it does today
when this value is selected
• Pending
• Failed
• Printed/Transmitted
Note that to display Generated Only or both Scheduled and Generated
reports, configure the common profile switch Allows Bulk Reporting screen
to show Generated Reports Only as follows:
• For Generated Only reports, set the profile switch as Bulk Reporting will
allow filtering on generated reports only.
• For Scheduled/Generated reports, set the profile switch as Bulk
Reporting will allow filtering on both scheduled and generated
reports.
Report Status Choose either Scheduled/Generated, Pending, Failed, or Printed/Transmitted
from the drop-down list.
Print Regulatory Report Prints the report as Draft or Final. The Draft option is disabled when the
printing option is set to Transmit.
Select Medical Summary to view the list of only medical summaries of distinct
cases in a PDF.
Approved Reports Only Filters reports for only approved reports.
View All Displays the bulk reports applicable to your filter selections.
Product Family Enter a Product family to view all cases where the scheduled reports belong to
the searched Product family.
Study ID Filters reports on the basis of the Study ID.
Product Group Filters reports on the basis of the Product Group. If a value is selected in the
Product Group filter, the Product Family drop-down list's values automatically
narrow down to the product families which belong to the selected Product
Group filter.
Specific Case # To search a case, enter the Case Number, and click Retrieve.

View bulk report filter results

The filter search results appears in the Total Number of Rows section.

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Field Description
Suspect Product Displays the Trade Name for which the report has been scheduled. If more
than one Suspect Company Product exists for the case, an (+) is placed at the
end of the product name.
For Reports which were scheduled for the Device, the Device name is
displayed.
Diagnosis Displays the Primary Event Diagnoses PT.
(Event Verbatim) Displays the (Verbatim as reported) of the Primary Event.
S/U/R • Displays the Case Level Assessments:
– Serious (Y/N)
– Unlisted (Y/N)
– Causality (Y/N)
• Unknown is treated as a "?"
• The SUR link displays the Case Summary for the selected case.
F or LT Fatal / Life Threatening
• If any of the events in the case are Fatal (F) or Life Threatening (LT) is
displayed.
• If the case is both F and LT, only F is displayed.
• If the case is neither F nor LT, only No is displayed.
7/15 Number of days for which the report is due:
• 7—if the report is within 7 days
• 15—if the report is due for more than 7 days
Indicates that the labeling was not assessed for the license for which the
report was scheduled. When you click the icon, the Local Labeling screen
opens.
A license is considered assessed:
• if it has been done through local labeling (marked as assessed);
• if there is a justification associated with the listedness, i.e., the value was
changed from Unknown to Listed or Labeled, or the datasheet
computed value was modified by the user.
Blind Study Product Transmits and prints study cases with blinded information.
Mark as Submitted 1. Select this option to mark reports as Submitted when the transmission or
e-mail has been sent.
A confirmation dialog box appears if this option is not selected.
2. Select Yes or No.
This selection is remembered for the next time when you print a report.

Report Form Displays the Description of the report.

Click the Report form link to view the DRAFT Report as a PDF.
Destination Displays the report destination (agency) for which the report is scheduled.
Downgrade Allows the user to view if the report is downgrade.
Displays Yes if the report is a downgrade report else No.
View All Allows administrator and workflow manager to see all items in the system.

Tip:
The icon (displayed in the lock state) in the Reports > Bulk Reporting screen
denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

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Submit a periodic report

Print reports in bulk

Field Description
Blind Study Product Check this checkbox to print study cases with blinded information.
Mark as Submitted Check this checkbox to mark reports as Submitted when the transmission/
email has been sent.
A dialog box is displayed if this checkbox is not selected. This dialog box
prompts you to confirm if the report is marked as submitted or not.
Select Yes or No, as required. This selection is remembered for the next time
when you print a report.
Print Medical Summary Allows the user to print the Medical Summaries.
Print Allows you to choose the printer for the selected report from the Select Site
Printer dialog box.
Select the Site and Printer Name where you wish to print the report and click
OK.
Print List Allows the user to print the current view of the Bulk Reporting.

Sort cases
To sort the cases based on the case status, click the Lock State header row.
• Lock State
• SUSAR
• Exp/Per
These options enable you to sort cases based on the case categorization.

Tip:
The icon (displayed in the lock state) in the Reports > Bulk Reporting screen
denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Lock state icon options

Click the Lock State icon to view the list of available options.

Field Description
View Report Displays the Draft report.
Report Details Displays specific information about the report as entered in the Regulatory
Reports section.
Case Summary Displays the Case Summary dialog box.
Remove Report Deletes the report from the case on being asked for a justification.
Mark for Non- Displays the Submission tab in the Report Details dialog box.
Submission Select No for Mark for Non-Submission and enter the reason for the non-
submission.

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Track your periodic report submission

Track your periodic report submission

In this section:
• Use submitted reports search results
• Reopen submitted reports
• About initial and follow-up cases in periodic reports
• View batch reports scheduled for generation

Use submitted reports search results

Field Description
Time Frame (I/F-u) Displays whether the report was initial or follow-up.
Product Displays the first suspect product for the case on which the report is based
(expedited reports).
License Type Displays the license type of the report.
Primary Event Displays the first event term for the case on which the report is based (expedited
reports).
Reason for Displays the reason provided for scheduling the report.
Scheduling
Report Form Displays the type of report scheduled (form) and initial/follow-up status (e.g.
"Initial Report" or "Follow-up #3").
Submitted Date Displays the report's submission date.
Case Del. Date Displays the date when the case was deleted.
Blind Study Product Enables you to mark the study product as blinded. When you manually schedule
a report, the system enables you to check Blind Product Study on the
Schedule New Expedited Report dialog box to blind the study products if they
are in the case.
Print All Submitted Enables you to print all the submitted reports.
Reports

Reopen submitted reports

Cases that are archived while unsubmitting reports can be reopened from the Archived Case
dialog box.
1. Enter the password and notes required in the Archived Case dialog box.
2. When the system opens the Report Unsubmit dialog box, enter the reason for unsubmitting
the report and click OK.
3. The system unsubmits the report.

Tip:
The icon (displayed in the lock state column) in the Reports > Compliance -
Expedited and Reports > Compliance - Submitted screens denotes a
SUSAR case.

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Track your periodic report submission

About initial and follow-up cases in periodic reports

A case is categorized as follow-up only if it has been previously submitted to the same
regulatory agency, report form type and configured product/licenses or study. Otherwise, it is
considered initial.

View batch reports scheduled for generation

• To view this list of System, Expedited, and Periodic reports that scheduled for generation,
from the Utilities drop-down menu, select Batch Reports.
• To delete a batch report, select the corresponding checkbox, and click Delete.

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8
Work in a multi-tenant Oracle Argus
environment
In this chapter:
• Access your global worklist items
• FAQs
• What If

Access your global worklist items

1. Enter the URL address for the Global Portal homepage in a browser window.
2. In the Application Access Portlet, select a tenant from the Enterprise drop-down list, and
an Oracle Argus application to launch from the Application drop-down list.
3. Select the Global Worklists tab.

Note:
The data from Global Worklists is not exclusively Oracle Argus Safety data. In
addition to Oracle Argus Safety, you can also access data from Oracle Argus
Insight and Oracle Argus Affiliate for the selected tenant.

4. To view global worklist items based on user assignment, from the top right of the screen,
select one of the following:
• Individual—For worklist items assigned to you across the tenants you are authorized
for.
• Group—For worklist items assigned to any other member of your user group across
tenants you are authorized for.
• All — For worklist items across all user groups across tenants you are authorized for.

Note:
This option is available only if you have the Workflow Manager right.

5. To further narrow the search results based on specific work item details, enter search
criteria in the relevant fields in the grey area at the center of the page.

Tip:
You can use predictive text to complete these fields.

6. Click the link for a case number.

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FAQs

FAQs
• What is a tenant?
• What is multi-tenancy?
• Can I open both the Global Portal homepage and the Oracle Argus Safety application in
my browser?
• Can I open the Oracle Argus Safety application a second time for the same or a different
tenant?
• Can I open the Oracle Argus Safety application for different tenants?
• Can I launch different Oracle Argus applications in separate browser windows?
• Is there a Japanese version of the Global Portal homepage?
• Which actions can I perform from my global worklist?
• Can I perform actions on multiple cases from my global worklist?
• Can I open Oracle Argus Safety cases for multiple tenants from my global worklist?
• How can I close or exit from the Global Portal homepage?

What is a tenant?
A tenant is a client to which a CRO assigned a logical section of the Oracle Argus Safety
environment within multi-tenancy. Depending on business needs, tenants can use specific data
configurations and access distinct Oracle Argus Safety modules. However, they cannot access
data that belongs to other tenants. Each tenant has a unique identifier in multi-tenancy called
enterprise ID.

What is multi-tenancy?
Multi-tenancy is an Oracle Argus Safety feature that can be enabled with Single Sign-On to
allow CROs to share their environment between multiple independent clients called tenants.
The environment is partitioned so that the tenants can access specific Oracle Argus Safety
modules and use customized data configurations as needed.
In multi-tenant environments, authorized SSO users can review cases and case actions, and
manage worklist items that they are responsible for across any number of tenants.

Can I open both the Global Portal homepage and the Oracle Argus Safety
application in my browser?
Yes, you can open both sites by entering their URL addresses in different tabs in your browser.

Can I open the Oracle Argus Safety application a second time for the same
or a different tenant?
Yes, you can open Oracle Argus Safety a second time for the same or a different tenant.
However, the application will open in the same browser window in which the application is
already open.

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FAQs

Can I open the Oracle Argus Safety application for different tenants?
Yes, you can open the Oracle Argus Safety application for different tenants, provided you close
the Oracle Argus Safety application for the existing tenant before you open it for a new one.

Can I launch different Oracle Argus applications in separate browser

windows?
Yes, you can launch different Oracle Argus applications in separate browser windows.
However, if you attempt to open the same Oracle Argus application for the same or a different
tenant, the application will open in the same browser window in which the application is already
opened.

Is there a Japanese version of the Global Portal homepage?

The Japanese version of the Global Portal homepage and related screens is not supported yet.
However, the features and functionalities that are specific to Oracle Argus Safety Japan and
Argus J users apply also to multi-tenancy environments.

Which actions can I perform from my global worklist?

Depending on your role and access rights, you can use your global worklist to:
• Search for a case. Perform case actions on a case, for example:
– Open as Read-only
– Accept Case
– Adjust Priority
– Adjust Assignment
– Adjust Case Owner
– Close Case
– Perform Coding Review or Medical Review
– View a Case Summary
• Manage your worklist items, for example:
– Close Action Item
– Print Worklist
– Generate Letter

Can I perform actions on multiple cases from my global worklist?

Global Worklist pages do not support simultaneous actions on multiple cases, such as Close
Multiple Cases, Route Multiple Cases, Print Multiple Cases, and Assign Multiple Cases. These
options are only available on the Oracle Argus Safety Worklist Open page. If you use the
Route multiple cases option in Case Action > Open and Worklist > New/Open, then
the cases would not get locked even if the workflow rule is configured for locking the case on
route.

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What If

Can I open Oracle Argus Safety cases for multiple tenants from my global
worklist?
No. If you have an open Oracle Argus Safety case for a tenant, you must save and close the
case before you open a case for another tenant.

How can I close or exit from the Global Portal homepage?

To close or exit from the Global Portal homepage (GHP), use the X button from the top-right
corner of the screen.

What If
• There are no items in my global worklist
• I can't see cases for a tenant even though I used its Enterprise ID as search criteria for my
global worklist
• The results list from my global worklist includes case data items that are not referred to by
worklist menu actions
• A case data item appears in my Oracle Argus Safety worklist, but does not appear in the
results list from my global worklist

There are no items in my global worklist

If no work items appear in your global worklist, then you are not authorized for any tenant.

I can't see cases for a tenant even though I used its Enterprise ID as search
criteria for my global worklist
The results list from your global worklist shows cases only for tenants you are authorized for.

The results list from my global worklist includes case data items that are not
referred to by worklist menu actions
The fields and columns from your global worklist results list are configurable by Administrators.
If the respective field or column is not relevant for your work actions from your global worklist,
contact your Administrator to configure it as hidden.

A case data item appears in my Oracle Argus Safety worklist, but does not
appear in the results list from my global worklist
The respective case data item may be configured as hidden in your global worklist. Contact
your Administrator to change the setting for the item to visible.

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9
Argus Unblinding Advanced
End-of-Study Unblinding (EOSU) is the process in which a blinded study is unblinded after the
study ends and investigators and/or participants are informed which treatment the participant is
receiving. When the study is unblinded in the clinical system, the safety cases for same must
be unblinded in Argus Safety. This activity is usually performed in bulk for all the cases
belonging to the study.
Oracle Argus supports the functionality of End-of-Study Unblinding via Argus Safety user
interface, which can be accessed from Argus > Utilities > Argus Unblinding >
Unblinding Advanced. This interface is available only if you belong to a user group with
menu access to Argus Unblinding.
Unblinding Advanced allows you to create, maintain, execute, and track End-of- Study
Unblinding profiles and status. It also enables you to generate a Study Case Report for a
profile/study ID, which details the cases present in Argus Safety for that study.

Note:
The profiles available in the Argus Unblinding Client Server module are also reflected
in the Unblinding Advanced screen.
Oracle recommends to use Unblinding Advanced for new profile creation and
execution.

WARNING:
The Argus Unblinding Client Server module will be deprecated in the future release.

For more information, see:

• Unblinding Advanced - Options
• Configure an unblinding profile
• Execute an unblinding profile
• View Argus Unblinding log

Unblinding Advanced - Options

Field Name Description
New Profile Launches the EOSU Profile page where you can
configure a new EOSU profile and save.

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Unblinding Advanced - Options

Field Name Description

View/Modify Profile Launches the selected EOSU Profile page with all
the existing saved data. You can update this data, if
required.
If the status of the unblinding process is In
Progress, then the profile page opens as read-only
with the options to download template, logs, and
loading report.
Use this screen to execute the profile to initiate
unblinding of the cases.
Delete Enables you to delete a profile.
You cannot delete a profile, if the profile has
completed execution in the Update mode and has
unblinded cases .
This button is disabled when the profile execution is
in progress.
Study Case Report This button is enabled when an existing profile is
selected and generates a report on the cases
belonging to the Study ID for that profile.
You can generate a report even during execution of
a profile.
The study case report generates a report in .TXT
format containing all of the non-deleted cases
belonging to the specified study ID in the profile.
The report displays a list of cases divided into the
following sections:
• Locked or Closed Blinded Suspected cases
• Not Locked and Not Closed Blinded Suspected
cases
• Locked or Closed Blinded Not-Suspected
cases
• Not Locked or Not Closed Blinded Not-
Suspected cases
• Locked or Closed Cases Un-blinded (during
study) cases
• Not Locked or Not Closed Cases Un-blinded
(during study) cases
• Suspected Cases which were Un-blinded
following the study end
• Non-Suspected Cases that were Un-blinded
following the study end
• Pending Report Submission Blinded
Suspected cases
• Pending Report Submission Blinded Not-
Suspected cases
• Pending Report Submission Un-blinded
(during trial) cases
• Suspected Cases Unblinded AT END OF
Specified Trial and need manual local data
entry and local Lock
• Not Suspected Cases Unblinded AT END OF
Specified Trial and need manual local data
entry and local Lock
Note: The sections mentioned above as Closed
implies that the case is archived.

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Configure an unblinding profile

Field Name Description

Print List Prints all the configured profile names along with
details in the Unblinding Advanced screen.

Configure an unblinding profile

You can create a new unblinding profile, view or modify an existing unblinding profile.

To create a new profile:

1. Go to Argus > Utilities > Argus Unblinding > Unblinding Advanced.
2. Click New Profile.
3. Enter the information in the following sections:
• Profile Definition
• Product and Dosage Mapping
• Unblinding Attributes
• Logs

4. Click Save.

Profile Definition
1. In Profile Name, enter a unique name for the profile.

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Configure an unblinding profile

2. To select a Study ID, click Search adjacent to this field.

a. In the Study Search dialog, search by study ID or project ID.
The result list for the search for study ID displays studies that are marked as Eligible
for unblinding belonging to the same enterprise as your log-in.
b. From the search result, select the Study ID.
There can only be one profile for one Study ID. Same Study ID cannot be associated with
different profile names.
Once a profile has been saved at the first entry, the selected study ID and profile name
cannot be changed.
3. In Randomization Data File, browse to a Patient Randomization data file (PRD) file, and
click Load.

Note:
Make sure you have obtained the complete set of PRD data from the external
official source. Also, the PRD file must be an Excel file (.xls or .xlsx) in a fixed
template (columns must contain data in the prescribed order and column names).
(Optional) Click Template to download the randomization file template. The
default name of this file is EOSU PRD Template. The certified file size if upto
2MB.

The PRD file can contain multiple rows of patient data in the following order without
altering the header names:
a. Study ID
b. Country
c. Centre
d. Patient Randomization Number
e. Treatment Code
f. Patient ID

Note:
Leading zeros and spaces in the PRD file are trimmed by the Argus Unblinding
system during validation.

When loading is complete, the PRD loading report can be downloaded to view the valid
and invalid rows with relevant messages. In case of discrepancies in the PRD file, relevant
error message appears when you click Load.
The profile is automatically saved on the first successful load, and the Load button is
disabled. The Load button is enabled only when you select a new PRD file for loading, and
overwrites the existing file.
Without a successfully valid loaded randomization data, product mapping and execution of
profile is not possible. If the loading report has all invalid rows, you will not be able to
execute the profile.

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Table 9-1 PRD file validation logic

Field name Validation logic Mandatory/Optional

Study ID Match to data in LM_STUDIES. Mandatory
STUDY_NUM
Country Match to data in Optional
LM_COUNTRIES. COUNTRY
Centre Match to data in LM_CENTERS. Optional
CENTER_NO
PRN [Patient Randomization Match to data in The PRD file must have either
Number] CASE_PAT_INFO.PAT_SUBJ_NU PRN or Patient ID.
M.
Patient ID Match to data in The PRD file must have either
CASE_PAT_INFO.PAT_ID. PRN or Patient ID.
Treatment Code This value is mapped to study Mandatory
drugs in the unblinding profile.
Maximum size allowed is 10
characters.

Advanced Condition (Optional)

Select a standard advanced condition to restrict cases that are executed for unblinding. You
can select an existing advanced condition or create a new one and attach the same.
You can apply only those advanced condition for which you have permissions.

Product and Dosage Mapping

This section is enabled only when a PRD file is successfully loaded for this unblinding profile.
• Treatment Code - The data on this tab is arranged into records, the number of records
being derived from PRD for every treatment code belonging to the study ID.

Note:
Treatment codes are provided by the clinical source data and need not be same
as study names in Argus.

One record per distinct treatment code from the PRD is displayed and must have a
treatment code - product pair along with Dosage options.
For example, if the randomization data contains two treatment codes DIASTUDY and
DIASTUDY1, then this section allows you to define the study drug for those two treatment
codes.
• Study Product - This drop-down contains a list of all blinded products (Drugs, Devices,
Vaccines) defined for Study ID (all study names/arms) specified in the Argus Console >
Business Configuration > Study Definition (Blinded company and non-
company Products).
• To map multiple products for the same treatment code to enable unblinding of comparator
products, click ADD in the product mapping section. This creates a new blank record with
first available treatment code as default.

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– Select a treatment code from the Treatment Code drop-down that list all the valid
treatment codes from PRD.
– Select the study product from the Study Product drop-down which is populated as
described in the above point.
– Select Dosage for the newly added row after selection of the study product. The
available options are:
* Add to Existing Dosages - Allows you to define values for a set of dosage regimen
fields. When the unblinding profile is executed, a record is created in the Dosage
Regimen section of the case in addition to any existing dosage regimen records for
the relevant study drug.
* Replace All by Following Dosages - Allows you to define values for a set of dosage
regimen fields. When the unblinding profile is executed, dosage records are
created in the Dosage Regimen section of the case, and replaces any and all
existing dosage regimen records for the relevant study drug.
* Remove All Existing Dosages - The Dosage fields are disabled and cannot be
edited. You cannot edit or add any new dosage information. When the unblinding
profile is executed, all dosage regimen records belonging to the relevant drug are
deleted.
* No Changes to Dosages (default) - The Dosage fields are disabled and cannot be
edited. You cannot edit or add any new dosage information. When the unblinding
profile is executed, all dosage information in the Case Form is retained without any
changes.
If you update an existing Dosage option from No Changes to Dosages to any other
option or add new dosage rows, the Select button changes to Update.
Select the Dosage Regimen for the treatment code based on the dosage rules
defined at treatment-study drug level. You may define one or more dosage for each
treatment code-study drug in this section.
– Click OK to save changes.

Unblinding Attributes and Mode

• Narrative (Optional) - Enter a standard piece of narrative that is appended to the existing
Case Narrative upon successful completion of the cases unblinding.
By default, this field displays the text Case unblinded due to end of study. You
can edit as per your requirement.
• Workflow State - Select a workflow state in which a case is placed when unblinding is
successfully completed, and no expedited report has been scheduled by the unblinding
procedure. By default, the state is Closed.
• Reporting - Check the Run Reporting Rules check box to run all reporting rules
configured in Argus, and schedule reports against the cases that are unblinded by the
unblinding process. By default, this check box is unchecked.
When checked, the Reporting workflow state and Expedited reports group fields are
enabled. These are mandatory fields for execution.
Reporting workflow state lists all the available workflow states. This field takes
precedence over Workflow State when the report is scheduled for the case.
Expedited reports group lists all the available user groups. Select a group to which the
report is assigned when scheduled.
• Unblinding Mode - Select a mode to execute the unblinding process. The availble modes
are:

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Execute an unblinding profile

– Dry Run mode (default) - Acts as a preview of the unblinding execution after unblinding
and closing of case is successfully completed. It produces the execution log files and
exception log files without actually unblinding the cases and saving the changes to the
database.
– Update Mode - Commits all the changes done during the unblinding processing to the
database. The execution and exception logs are generated with details.

Execute an unblinding profile

This section describes the functional behavior of the Advanced Unblinding module.
1. Go to Argus > Utilities > Argus Unblinding > Unblinding Advanced.
2. Select a profile, click View/Modify, and then click Execute.
The application validates the following, before beginning the unblinding execution process.
• User privileges - You must have the following privileges to execute an unblinding
profile:
– Allow unblinding of cases
– Allow locking of cases
– Allow closing of cases
If you do not have any of these privileges, a relevant message appears.
• Each product mapping must be unique. Each treatment must be mapped to a different
study in the product mapping.
• A study drug mapping for every treatment code is added.
• Reporting workflow and Reports Group are provided, if Run Reporting Rules is
checked.
• If Dosage Options is selected as Add to Existing Dosage or Replace all by
following Dosage, then dosage regimen values are provided.
3. When successfully validated, the execution process runs in the background through AG
service with the following details:
• Task Name: End Of Study Unblinding
• Default User ID: oagsvc_end_of_study_unblinding_1
• Multiple Instances Allowed: Yes
You can execute multiple different unblinding profiles at the same time by one or multiple
users.
However, when the execution process starts for a profile, for all users, Configuration screen
becomes un-editable and in the read-only mode until the unblinding process completes for that
profile. Besides, you cannot cancel the execution process.

Criteria for a case to qualify for unblinding

A qualifying case must meet one of the following criteria:
• Case belongs to the specified clinical study ID (including archived cases).
• Case has not had the blind broken previously. That is, the Blinding Status field is not equal
to Broken by Sponsor or Broken by Investigator.
• Case has not previously been successfully processed by the End of Study Unblinding
program.

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• Case satisfies the advanced condition, if specified.

• Case is not deleted.

Note:
The case status (whether it is open, closed, locked etc.) is irrelevant at the start of the
process. Unlocked and open cases fail during the unblinding process.

Process the qualifying case

For each qualifying case the following processing is performed:
1. If the case is not locked or case is not closed (open by a user), then the case ID is added
to the exception tables, with the failure reason Case is unlocked (globally
and/or locally) or open.
2. If the case is currently closed, add the re-open information to record that the case has
been re-opened by EOSU.
3. If the case is locked (both Global and Local), then add the unlock information to record that
the case has been unlocked by EOSU.

Inspect the Patient Randomization tables

Inspect the Patient Randomization tables to map the patient for the current case with a specific
study product based on the following algorithm:
1. Select the Country of Incidence, Study ID and Patient Randomization Number (or) Patient
ID for the current case.
2. If any of the data is NULL for the case being processed, then write an exception Case is
missing Country or Study or Center or PRD#. Blind cannot be broken
without these fields. and move to the next case.
3. Attempt to find a matching record in the randomization data using the Country, Study ID,
Centre Number and Randomization number (or) Patient ID obtained from the current case.
4. During the above matching against the randomization data, all records with either of the
columns (Study, Country, Center, Randomization Number, and Treatment Code) as invalid
are not considered for a match.
5. If duplicate entries in the randomization data are obtained for this combination, then log the
message Duplicate entries in Randomization Data (Study+Rand#/
Patient ID) are matching the Case Data. in the exception report and move to
the next case.
6. If a match is found, then read the study drug treatment code for that randomization record.
This is based on the Treatment Code to Study Product mapping table. That is, an attempt
is made to match the Study Drug of the current case with the relevant randomization
record via the Treatment to Study Product mapping table.
7. If no record can be found, then write the case ID to the exception list, along with the failure
reason, and move onto the next case.
8. If the study drug mapped to the treatment code does not belong to the study name/study
arm the patient belongs to in Argus Safety case, then an error message appears in the
exception log as The Patient Exposure drug could not be located in
LM_STUDIES.

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View Argus Unblinding log

Dosage regimen
If the derived Study Drug is configured with dosage regime, then dosage regimen in case is
marked as updated/added/no updates made based on the profile configuration settings. The
case’s Un-Blinding Status field is set to Broken After Study, Un-blinding date is set to System
(Database) date and time, and set the Product Administered Drug for the Study Drug.

Unblinding of other drugs

Unblinding of Investigational, Comparator, Additional or Placebo Drugs also follow the same
logic. Unblinding must be performed using the company product or WHO Drug products.
If any new expedited reports are scheduled, then set the Case Workflow State to the Reporting
Workflow State and assign the report to the configured reporting group.

When Unblinding is complete

• Event Assessment is recalculated after the case is unblinded.
• If the case was locked at the start of the process, then re-lock it.
• If the case was closed at the start of the process, and the case does not have regulatory
report scheduling due, then re-close it.
• If any expedited reports are scheduled, then lock the case, irrespective of the state of the
case prior to processing.
• Create a significant follow-up entry for the current case – giving the current date as the
date of follow up and the central receipt date.
• Save the changes to the case (i.e., commit the changes to the database; set the Last
Saved Date to the current date and time; set the Last Update user to the value of the
current Argus Safety username).

View Argus Unblinding log

Log files for the execution of the unblinding process are available in the profile screen as a list
down for download. The latest log is available at the top.
Two log files are generated for every execution of a profile. One file for the unblinding process
execution and other for the exception. Both Dry Run and Update modes produce Logs.
The log files are named as Date time stamp-Type-12 characters of profile name- Mode. The
timestamp reflects GMT.
For example:

05 JAN 2024 06:51:30-EOSUProcessLog-Study14USA-Update

05 JAN 2024 06:51:30-ExceptionLog-Study14USA-Update
05 JAN 2024 06:50:30-EOSUProcessLog-Study14USA-DryRun
05 JAN 2024 06:50:30-ExceptionLog-Study14USA- DryRun

The execution log file has a header with all the details of the unblinding profile and selected
parameters, randomization data summary, unblinding attributes, and unblinding procedure log
case by case.
The exception log file has a header with all details of the unblinding profile and an exception
report: list of cases with exception message

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