Oracle Argus Safety

User's Guide

Release 8.4.2
F90408-01
January 2024
Oracle Argus Safety User's Guide, Release 8.4.2

F90408-01

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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
Log out 1-8
Dynamic workflow indicator 1-8
Integrate with Oracle Argus Insight 1-9
Sharing a case series in Oracle Argus Safety with Oracle Argus Insight 1-9
Sharing a case series in Oracle Argus Insight with Oracle Argus Safety 1-9
Case form user preferences 1-9
Scale and Layout 1-10
FAQs 1-10
What happens if I enter a wrong password? 1-11
Why can't I change my password? 1-11
How do I get help? 1-12
How do I view contents of the generated PDF when it contains uncommon or
unsupported characters? 1-12
How do I trigger autocalculation? 1-12

iii
 How do I generate batch reports? 1-12

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
Initial case entry—BookIn dialog box 2-5
Accept incoming cases 2-5
View pending case 2-5
View rejected cases 2-6
Enter general information 2-6
General information—field descriptions 2-6
Enter study information 2-8
Study information—field descriptions 2-8
Enter reporter information 2-9
Add reporter information 2-9
Reporter information—field descriptions 2-10
Enter literature information 2-11
Enter patient information 2-11
Enter current medical status 2-11
Copy patient information from reporter information 2-12
Patient information—field descriptions 2-12
Enter patient notes 2-13
Enter patient details 2-13
Enter pregnancy information 2-14
Enter patient death details 2-15
Event death details—field descriptions 2-15
Enter other relevant history 2-15
Other relevant history—field descriptions 2-15
Enter lab data—lab test and test results 2-17
Lab data—field descriptions 2-18
Enter additional test information 2-18
Enter parent information 2-18
Enter product information 2-19
Search for products 2-19
Product Browser based search 2-19
WHO Drug Browser based search 2-20
Enter time measurement information 2-21

iv
 Enter drug information 2-21
Product information—field descriptions 2-22
Enter product indications on the drug tab 2-27
Enter Quality Control information 2-28
Enter dosage regimens 2-29
Enter product details 2-30
Enter study drug information 2-31
Enter device information 2-32
Enter product information 2-32
Enter Quality Control information on the Device tab 2-35
Enter product indications 2-35
Select product delivered by device 2-35
Enter device component information 2-35
Device information—field descriptions 2-36
Enter vaccine information 2-38
Enter product details 2-39
Enter prior adverse events information 2-39
Enter product information 2-39
Complete vaccine administration form 2-40
Enter vaccine history 2-40
Enter event information 2-41
Events tab—field descriptions 2-41
Enter data on the Event Information tab 2-42
Event information—field descriptions 2-42
Review a diagnosis-event relationship 2-43
Associate a symptom with the diagnosis 2-44
Auto-populate event information 2-45
Configure regulatory reporting rules 2-45
Enter event coding information 2-45
Enter seriousness criteria 2-46
Enter death details 2-46
Enter hospitalization details 2-46
Select nature of event 2-47
Enter event notes 2-47
Enter event assessment information 2-47
Event assessment tab—user actions 2-49
Filter event assessment details 2-50
Enter product-event details 2-51
Add attachments to your case 2-51
Enter additional information for the attachments 2-52
Sort attachments 2-54

v
 Search for Documentum links 2-54
Attach files to a case 2-54
Enter keywords 2-55
Attach references to a case 2-55
View and print attachments 2-55
Review local labeling 2-55
Enable local data entry for Japan 2-56
Enable local data entry 2-57
About local fields 2-57
Access local case data lock functionality 2-58
Process an outlier 2-60
Activate local locking in Oracle Argus Safety 2-60
Enter local reports configuration seed data 2-61
Enter local users seed data 2-61
Enter local fields seed data 2-61

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
Add a follow-up event to a case 3-5
Unblind cases to a study 3-5
Copy a case 3-5
Lock or unlock a case 3-6
Delete a case 3-7
Undelete a case 3-7
Formally close a case 3-7
Print case details for a case 3-8
Print letters and attachments for a case 3-8
Review cases 3-9
View correspondence contacts for a case 3-9
Generate a letter on a case 3-9
Track correspondence for a case 3-10
View case action items 3-10
View revisions for a case 3-11

vi
 View the audit log for a case 3-11
View the coding status of a case 3-12
Perform a medical review of a case 3-12
Perform a coding review of a case 3-13
Perform a regulatory submission review of a case 3-13
FAQs 3-15
What is a case owner? 3-17
Can I reassign a case to another owner? 3-17
When does a case become open? 3-17
How do I create a query-type action item for a case? 3-17
What happens to a query-type action item after its due date has passed? 3-17
How can I view a summary of all the open cases? 3-17
How can I view a summary of cases with open action items? 3-17
When can I formally close a case? 3-17
What happens to a study if I unblind the cases that are associated with it? 3-18
How can I track which case revision contains significant follow-up information for the
case? 3-18
How can I interpret the differences between two narratives for a case? 3-18
What other case details can I retrieve from the Routing Comments log? 3-18
Can I view the original case from a copied case? 3-19
What are the lock states for a case? 3-19
Can I apply a local lock on a case that already has a local lock for another country? 3-19
If I am an Oracle Argus Safety Japan user, can I enter local data, copy or modify a
case that has a global lock? 3-19
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? 3-19
Can I change the outcome of a case as part of my medical review for the case? 3-20
Can I change the causality for a case during my medical review? 3-20
What do the case assessment values stand for? 3-20
Who is the MDR contact person? 3-20
How does Oracle Argus Safety set the Receipt Date for a case? 3-20
How does Oracle Argus Safety set the Aware Date for a case? 3-21
How does Oracle Argus Safety set the Date Received value for a case? 3-21
Which actions can I perform on a saved letter? 3-21
Can I edit or remove a letter after it was sent for a case? 3-21
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? 3-21
Where can I view action items for letters? 3-21
Why do only some action items for a case appear as Sent in Letter? 3-22
Can I auto-generate a letter for a case? 3-22
Which actions can I do on an auto-generated letter? 3-22
What does the coding status icon indicate for a case? 3-22

vii
 Why does a border appear for a coding action item for a case? 3-22
Why is there a green dot in the Notes area of a case summary? 3-22
Why do only some user names appear in bold in the Case Workload? 3-23
Why does the () icon appear as the lock state icon for a case? 3-23
Why do some letter icons from the Contact Log have an exclamation mark? 3-23
Why does an asterisk (*) symbol appear next to the username for some users in the
Case Routing dialog? 3-23
How to attach multiple files to a single letter for follow ups? 3-23
What if 3-23
The Medical Review page appears empty for a Case Form 3-24
The narrative text for a case contains blank spaces or placeholders 3-24
I can't change the assessed seriousness of a case 3-24
I can't change the determined listedness of a case 3-24
I can't select the language I need for my text narrative? 3-24

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)? 4-7
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

viii
 FAQs 5-2
Which dictionaries does Argus Safety support? 5-2
What is the MedDRA browser? 5-2
What are the five levels of the MedDRA dictionary? 5-3
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? 5-4
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 5-5
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 6-4
Review your scheduled reports 6-5
Review a list of your scheduled reports 6-5
View your scheduled reports 6-5
View Expedited Report status 6-7
Submit your Expedited Reports 6-7
Generate an Expedited Report 6-7
Approve your report 6-8
Transmit an ICSR 6-9
Transmit several ICSRs at once 6-9
Filter reports 6-9
User options 6-10
View routing details 6-10
Print your reports 6-10

ix
 Bulk print user options 6-10
Store Expedited Reports in Documentum 6-11
Track your Expedited Report submissions 6-11
Track ICSR outgoing status 6-11
View ICSR transmit status 6-11
Search for reports 6-12
Search for ESM messages 6-13
View search results 6-13
ICSR Pending screen icons 6-14
Track your failed ICSR imports 6-16
Manage your Incoming ICSRs 6-17
Track incoming ICSR reports 6-17
Button and right-click options 6-18
Track bulk incoming ICSR reports 6-19
Search for duplicate reports 6-20
View duplicate search options 6-20
Search duplicates for incoming review 6-21
View differences report 6-22
Accept initial E2B cases as follow-up 6-23
View processed ICSR reports 6-23
Search for reports 6-24
View search results 6-24
Track ICSR incoming status 6-24
Find overdue reports 6-25
FAQs 6-25
What is a scheduled report? 6-25
What is a generated report? 6-26
What happens when a report is approved? 6-26
What is the difference between submitting and transmitting a report? 6-26
What happens when manually scheduling a Local Japan report? 6-26
What happens when auto-scheduling a Local Japan report? 6-26
What components are affected by the expedited reporting rules algorithm? 6-27
Suppression of duplicate reports 6-28
Blinded or forced distribution 6-28
When are follow-up reports created? 6-29
When are the amendments created? 6-29
Why can't I view a draft report? 6-30
Why doesn't my draft report print a follow-up number? 6-30
How does the Lock State Column under Reports > Compliance > Expedited allow me
to sort my cases? 6-30
How do I view the status of my Expedited Report? 6-31

x
 How do I know if an unscheduled report is due soon or needs to be submitted? 6-32
Where can I view single reports which have been generated as part of a periodic
report? 6-32

7 Manage your periodic report submissions

Prepare content for periodic reports 7-1
Prepare your aggregate reports 7-1
Understand aggregate reports 7-2
View saved aggregate reports 7-3
Create a Case Data Analysis report 7-3
Create a CIOMS II Line Listing report 7-4
Create a case listing report 7-5
Check aggregate report execution status 7-6
Periodic report types 7-6
Store periodic reports in Documentum 7-6
View a summary of periodic regulatory reports 7-6
Use the library page 7-7
Prepare content for a Clinical Trial Periodic Report 7-7
Create a Clinical Trial Periodic Report 7-8
Enter common fields information 7-8
Configure subject in the report header 7-8
Select products to include in CTPR 7-9
Configure license or study in the report header 7-10
Select inclusion criteria 7-10
Use the Data Lock Point (DLP) version 7-12
Use DLP queries for dates 7-13
Use As of Reporting function 7-13
Find DLP and As of Query functionality 7-13
Include line listing 7-13
Add data elements 7-13
View selected data elements 7-14
Group cases 7-14
Specify summary tabulations for line listing 7-15
Generate single case submission report 7-18
Select summary listing 7-19
Schedule the report 7-19
Setup frequency of the scheduled reports 7-20
Configure security level of the report 7-20
Use report templates 7-20
Prepare content for an ICH PSUR 7-20
Create Periodic Safety Update Reports (PSURs) 7-21

xi
 Enter common fields information 7-21
Configure subject in the report header 7-21
Select products to include in ICH PSUR 7-23
Select inclusion criteria 7-23
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 7-26
Include CIOMS reports 7-26
Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical
trials 7-27
Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from
Post-Marketing Data Sources 7-28
Add cumulative summary 7-28
Add FDA PSUR support information 7-29
Generate single case submission report 7-29
Select summary listing 7-30
Schedule the report 7-31
Setup frequency of the scheduled reports 7-31
Configure security level of the report 7-31
Use report templates 7-31
Prepare content for a US IND periodic report 7-31
Create new IND report 7-31
Enter common fields information 7-32
Configure subject in the report header 7-32
Select products to generate the report 7-33
Select inclusion criteria 7-33
Include line listing 7-34
Specify summary tabulations for line listing 7-34
Schedule the report 7-35
Configure security level of the report 7-35
Prepare content for an NDA periodic report 7-35
Create NDA summary report 7-36
Enter common fields information 7-37
Configure subject in the report header 7-37
Select products to generate the report 7-38
Select inclusion criteria 7-39
Include line listing 7-39
Specify summary tabulations for line listing 7-41
Schedule the report 7-41
Configure security level of the report 7-42

xii
 View scheduled periodic report information 7-42
Available user options 7-42
View report details 7-42
View report schedule details 7-43
View report routing history 7-43
Submit a periodic report 7-43
Specify submission details 7-43
Add comments 7-43
Transmit a report 7-44
View report generation status 7-44
Create unscheduled periodic reports 7-46
Approve and submit a report 7-47
View submitted reports 7-47
Use bulk report 7-48
Filter bulk reports 7-48
View bulk report filter results 7-49
Print reports in bulk 7-50
Sort cases 7-50
Lock state icon options 7-51
Track your periodic report submission 7-51
Use submitted reports search results 7-51
Reopen submitted reports 7-52
About initial and follow-up cases in periodic reports 7-52
View batch reports scheduled for generation 7-52

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? 8-3
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? 8-4
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

xiii
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
The results list from my global worklist includes case data items that are not referred to
by worklist menu actions 8-5
A case data item appears in my Oracle Argus Safety worklist, but does not appear in
the results list from my global worklist 8-5

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:

xv
 Preface

• English interface of Oracle Life Sciences Support Cloud (https://

hsgbu.custhelp.com/)
• 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
• Log out
• Dynamic workflow indicator
• Integrate with Oracle Argus Insight
• Case form user preferences
• Scale and Layout
• 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.

1-2
 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.

1-3
 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.

1-4
 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.
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

Language other than English or Japanese

For more information, see:

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Use other (than English) language text

• 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 Patient tab > Patient Information Patient Notes
4 Patient tab > Relevant Tests Patient Relevant History Tests
5 Patient tab > Other Relevant History Relevant History Notes
6 Patient tab > Pregnancy Information Delivery Notes
7 Parent tab > Other Relevant History Parent Relevant History Notes
8 Products tab > Product Information Product Name
9 Products tab > Product Information Product Generic Name
10 Products tab > Product Information Product Notes
11 Products tab > Product Indication Product Indication as reported
12 Products tab > Product Details Related Device Comments
13 Products tab > Device > Device Information Device Comments
14 Events tab > Event > Event Information Event Description as reported
15 Events tab > Event > Details Event Details
16 Events tab > Event > Cause of Death and Autopsy Death Cause as reported
Results
17 Analysis tab > Analysis > Case Analysis Evaluation in light of similar events in the
past
18 Analysis tab > Analysis > Case Analysis Case Comment
19 Analysis tab > Analysis > Case Analysis Abbreviated Narrative
20 Analysis tab > Analysis > Case Analysis Narrative

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Enter reasons for missing (Null Flavor) data

No. Case Form/ Console location Field name

21 Analysis tab > Analysis > Case Analysis Company Comment
22 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.

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

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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Integrate with Oracle Argus Insight

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.

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.

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:

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Scale and Layout

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.

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

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FAQs

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.

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Create a new case

4. A list of cases that match the criteria you entered on the form is displayed. Review
the search results for a duplicate case.
If a duplicate case exists, open the case to enter further information related to the
existing case. Click the link associated with the case.
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.
If the case number is not automatically generated, enter it according to your
company guidelines.
9. When the case creation message appears, click Yes.

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Create a new case

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
to clinical trial cases box.
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.
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.

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Create a new case

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.
3. Review the list to determine if any case contains duplicate information.
For more information, see:
• Receipt range—fields descriptions

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.
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 Based on Full Date Range - if only a year is entered, the date range
Receipt Date becomes: 60 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.

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Create a new case

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:
• 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.

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Enter general information

Field Description
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
• 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.

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Enter general information

Field/Control Name Description

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.
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.

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Field/Control Name Description

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. If the date of unblinding is more recent than the date for the
most significant follow-up information, an automatic follow-up is
generated.
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.

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Enter general information

– If you have reporter information in the case, the information appears in the
Reporter Lookup dialog box and search is performed.
– 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 Description
Name
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 If this checkbox is checked, the name and address of the reporter does
Confidentiality 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
Contact information is used in letters. You can select more than one reporter as
the correspondence contacts for the case.

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Field/Control Description
Name
Reporter ID If known, enter the Reporter ID. This completes the Case Form reporter
fields.
Reporter Type, These lists are maintained by the administrator.
Report Media, and
Intermediary
(New) Tab Creates details for a new reporter.

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.

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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.

Patient information—field descriptions

Field/Control Description
Name
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
Status from 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
(Title, First Name, initials fields. If the Patient Name or Initials are three characters or less,
MI, Last Name) this is 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 If this check box is selected, the patient's name and address will not
Confidentiality 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.

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Field/Control Description
Name
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.

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.

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Table 2-1 (Cont.) Patient Details—Field Descriptions

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

For more information, see:

• Enter pregnancy information

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.

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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.
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.

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Field or Control Description

Name
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.
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
Information with 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.

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Field or Control Description

Name
Product Identifier Displays the type of Product Identifier such as MPID, PhPID, and so on.
Type/ Product Enabled 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
Enables you to add the MFDS assigned Product Code.
Medicinal 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.

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.

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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.
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.

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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

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

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• 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
• Formulation/Strength (sequence 3 and sequence 4) of the product
• 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
– 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, a like search is performed (e.g., CUREALL%)
• You can use the percent (%) sign to perform wildcard searches
• If you click Full Search, the full search is performed (e.g., %CUREALL%)

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7. You can also search for drug formulation and country. This option is available only if you
select the WHO Drug C format.
8. To clear the search criteria you entered, click Clear.
9. 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."
• 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

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• 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.

Table 2-2 Product Information

Field or Control Description

Name
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
• Concomitant indicate the involvement of the product with the adverse event(s)
• Treatment/Other reported for the case.
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 Description

Name
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 Auto-populates based on the selected license in the Argus

Type 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.

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Table 2-2 (Cont.) Product Information

Field or Control Description

Name
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.
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.

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Table 2-2 (Cont.) Product Information

Field or Control Description

Name
WHO Medicinal Displays the Medicinal ID associated with the selected WHO drug. The
Product ID WHO Drug code used to identify the drug.

Note:
This ID is populated only if a WHO-drug
is selected.

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
Market Authorization Captures the name of the Marketing Authorization Holder of the product
Holder 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.

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Table 2-2 (Cont.) Product Information

Field or Control Description

Name
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.
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.

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Table 2-2 (Cont.) Product Information

Field or Control Description

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

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
• Coded Indication—Code for the reaction
Both the values could be different or same.

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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 add a date in the Product >
Quality Control > QC Result Date field.

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
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.

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Field Name Description

Quality Control Result Enter the date the result of the analysis was received by the Quality
Date Control 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 The cumulative dose to the time of the event.
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 Gestation Period at Exposure is automatically calculated for all
Exposure 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 / Select a response from the list.
Tolerated
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.

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Field or Control Name Description

Stop Date/Time Enter the date and/or time when the rechallenge was stopped.
Specialized Product Select specialized FDA product categories such as combination
Category products, compounded and repackaged products used in
eVAERS reports.
• Abuse Select the corresponding check boxes to provide information on
• Batch and lot tested the drug populated as Additional Information on Drug [G.k.10.r] in
and found within the E2B(R3) 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.

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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.
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.

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• 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).
• 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.

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• 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.
• 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.

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• 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.
• 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.

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Field or Control Name Description

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:

Field or Control Description

Name
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 Under Unique Identifier (UDI) #, enter any other applicable identification
(UDI) # 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 Enables you to capture whether the device was serviced by a third
Party party. The possible values are:
• Yes
• No
• Unknown
FDA Exemption This field is available for the eMDR report and provides a number
Number provided by 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.

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Field or Control Description

Name
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 This field is enabled when the Device Outcome field is set to Other.
Detail
Device Comments Allows you to enter details about the device.
Device Available for Indicate whether the device is available for evaluation. Also, indicate
Evaluation whether 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.

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 Enter the malfunction as determined by the company.
Malfunction
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
Device Problem following 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 code are fetched from the Event tab. The code
select option was removed.
Use the Medical Device Problem lookup to search the problem information.
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.

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Field or Control Name Description

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 2000 characters Alphanumeric
this report was also sent
Number of Patients Involved 3 characters Numeric
Number of Devices 3 characters Numeric
User facility reference number 20 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 N/A Checkbox
(Follow-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

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• 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 Select the VAERS Form block that this vaccine needs to be printed in.
Block
• 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.
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.

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Field or Control Name Description

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 Description

Name
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

Field or Control Description

Name
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 Description

Name
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.

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Enter event information

Field or Control Description

Name
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

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.

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• 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:
• 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 Description

Name
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.

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Field or Control Description

Name
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
Reporter major 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
History? the 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.

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.

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

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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.

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.

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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.
• 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 You can navigate to Case Form > Products > selected Product.
link
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 Displays the activation date, revision name, revision number of the latest
revision number/name datasheet revision on which the listedness assessment was made.
link Click Export to get a listing of all labeled terms in an Excel file.

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

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Field or Control Name Description

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
Determined/Source/ so 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.
• Non-company suspect products in Clinical
Trial 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 Description

Name
Product The Product filter drop-down list contains all products listed in the event
assessment. You can filter on all the products which are present in the
Event Assessment dialog box.
Event Contains a drop-down list of values of distinct Event PT. You can filter
PT(Description)/LLT on all the products which are present in the Event Assessment dialog
box.
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.

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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
• Search for Documentum links
• Attach files to a case
• Enter keywords

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• Attach references to a case

• View and print attachments

Enter additional information for the attachments

Notes and Attachments- field description

Field or Control Description

Name
Notes and Lets you sort column headers to sort the records based on the fields in
Attachments 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.

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

Reference Type Used in Report Description

E2B GP Medical No. E2B Add the medical number provided by
the specialist.
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.

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

Reference Type Used in Report Description

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.
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.

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.

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2. Click Browse to locate a file attachment.

3. Select the file and click OK.

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.

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

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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.
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.

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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.
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: Oracle Argus Safety Administration
Local Unlocking - Allow Local Locking - to allow a Guide > 2 Access Management >
Configuration local user to be set up with the Configuring Users
privilege to locally lock or unlock a Oracle Argus Safety Administration
case Guide > 4 System Configuration >
Enable Local Unlocking - to Configuring System Management -
provide a system level control Common Profile Switches
permitting local users to locally Oracle Argus Safety User's Guide >
unlock a case and make any Global User Management
corrections to the previously
entered local data.
Changes to the Introduction of action icon - Local Oracle Argus Safety User's Guide > 1
Case Locking Lock - to allow a user to locally Getting Started > Quick Launch
Mechanism in lock or unlock a case Toolbar
Oracle Argus
Safety - Case
Form Changes

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Local Lock Overview Documented in

Feature
Changes to the Allow Global locking and Oracle Argus Safety User's Guide >
Case Locking triggering of global and local Locking a Case
Mechanism in reports, and allow one step global
Oracle Argus and local locking
Safety - Changes
to global locking,
One Step Global
and Local Lock
Changes to the Introduction of new switches: Oracle Argus Safety Administration
Case Locking Allow Forced unlock (Global and Guide > 2 Access Management >
Mechanism in Local) - to allow users to be set up Configuring Users
Oracle Argus with the privilege to forcibly unlock Oracle Argus Safety Administration
Safety - Changes a case that been globally and/or Guide > 2 System Configuration >
to Global locally locked but pending report Configuring System Management -
Unlocking - generation Common Profile Switches
Configuration
Allow Global Unlock on Pending Oracle Argus Safety User's Guide >
Local Lock - to allow users to be Global User Management
set up with the privilege to forcibly
unlock a case that is still pending
a local lock
Changes to the Control globally unlocking a case Oracle Argus Safety User's Guide >
Case Locking based on local/global reports Unlocking a Case
mechanism in pending generation and /or cases
Oracle Argus pending local lock
Safety - Changes
to global
unlocking - Case
Form changes
Case Form Configuring Local Reporting Oracle Argus Safety Japan
changes - Local Rules and Local Reports Administration Guide > 3 System
Reports Configuration > Configuring Local
Configuration - Reports - Local Reporting Rule and
Local Reporting Local Reports
Rule and Local
Reports
Triggering Local Changes to report auto- Oracle Argus Safety User's Guide >
Reports - scheduling for scheduling local Report Scheduling - Auto-Scheduling
Changes to reports
Report
Scheduling and
Generation
Algorithm - Auto
Scheduling
Triggering Local Changes to report manual Oracle Argus Safety User's Guide >
Reports - scheduling for scheduling local Report Scheduling - Manual
Changes to reports Scheduling
Report
Scheduling
Algorithm -
Manual
Scheduling

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Local Lock Overview Documented in

Feature
Triggering Local Changes to report generation for Oracle Argus Safety User's Guide >
Reports - generating local reports Triggering Local Reports - Report
Changes to Generation Algorithm
Report
Generation
Algorithm
Changes to Changes to DLP while generating Oracle Argus Safety Japan User's
Expedited local expedited and periodic Guide > Reports
Reports and reports
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 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.

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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:

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.

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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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Process case data
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.

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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.
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
• 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:

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• 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.
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.

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.

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

1. Hover over the Utilities menu, and select End of Study.
2. In the End-of-Study-Unblinding dialog box, select a study from the End-of-Study
Unblinding drop-down list.

Note:
The End-of-Study-Unblinding dialog box doesn't include cases that are globally
or locally unlocked, or pending local or global report submission.

3. In the Dosage Regimens dialog box, click Select and enter the drug dosage information.
4. Click OK and then click OK again.

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.

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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.

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.

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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.
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.

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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.

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.

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7. Click the Print File icon at the bottom.

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.

• Check the checkbox corresponding to the type of case action item to view:

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– 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 F:
• If you selected Product Problem in block B, enter the National Drug Code
in Suspect Medications (NDC#).
• Select the option corresponding to the origin of the report – User Facility
or Distributor.
• If you don't want the MedWatch 3500A Drug Report to include information
from block F, select Suppress Block F Printing.
• Enter the report number in full as shown in the upper-right corner of the
screen in UF/Dist report number.
• Enter the details of the user facility or distributor reporting site in User
facility or distributor name/address.
• Enter the details of the contact person for medical device reporting (MDR)
in Contact person.
• Enter the date when the user facility's medical personnel or the distributor
became aware that the device may have caused or contributed to the
reported adverse event in Date aware of event.
• To delete an existing FDA Patient or Device code, select the row and click
Delete.
– The Select button from Patient Problem is disabled.
– The Add button allows you to add device problem codes and Patient
Problem code fields are disabled for data entry.
– This section only displays existing records.
– The application allows deletion of existing codes, if required.
• If a report was sent to the FDA, check the Report sent to FDA check box
and enter the date.
• If a report was sent to the manufacturer, select the Report sent to mfr?
check box and enter the date.

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d. 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.
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?

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• 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?
• 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?

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FAQs

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.

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.

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FAQs

• 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.

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.

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FAQs

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.

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.

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FAQs

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

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.

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FAQs

• 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:
• 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.

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FAQs

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.

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.

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What if

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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 Chapter 4
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.

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FAQs

To print the entire list of filters, check the checkbox from the heading, and click
Print List.
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.

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What if

What is a case series (formerly Hit list)?

A case series is the search result of a filter or set of filters. See also:
• 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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5
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.

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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).
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.

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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.

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

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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
• 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:

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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.
Protect If this check box is checked, the patient's name and address will not
Confidentiality of appear on any of the regulatory reports, and the patient information
Patient and Reporter will show the 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.

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Table 6-1 (Cont.) Expedited Reports - Fields and Fields Description

Field Description
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.

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.

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

Field Description
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:
• 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.

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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.
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

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– 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 Displays the report destination (agency) for which the report is
Destination 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
Incidence all 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.
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.

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Field Description
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

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.

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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.
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.

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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.
# 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.

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Field Description
Sender Agency Displays the name of the agency that has generated the report
Name
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 Failed transmissions can be removed using this option as it removes the
transmission 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
Reports submitted simultaneously.
Re-transmit The status of multiple reports that are selected from the list can be
Multiple changed to pending, and those reports can be re-transmitted.
Remove Multiple Transmission of multiple reports that are selected from the list can be
Transmissions removed.

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

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.

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Option Description
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
Reports submitted 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 jobs of multiple reports that are selected from the list can be
Print Jobs removed.

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.
1. Hover over the Worklist menu and select Bulk ICSR Transmit.
The Bulk ICSR Transmit page appears with following tabs:

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• 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.
Range Select a date range.

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Track your Expedited Report submissions

Field Description
Search button Triggers search based on the search criteria.
Only show Check this checkbox to search for only those transmissions that have a
transmissions that failed status.
have reached a
failure state
Show all When this checkbox is checked by the user during the Search action, the
transmissions system brings back any ICSR report that has received an error ACK
(submitted and (acknowledgement), irrespective of whether it has been marked as
unsubmitted) having submitted or not.
a error ACK 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
suppressed agencies, 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
(read -only) mode.

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.

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Table 6-3 (Cont.) Status icons descriptions

Icon Status Description

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.
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 Opens the ICSR validation report (pdf) in the same format as it does at
Failure 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.

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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 more than one criterion is selected, only cases
that satisfy all criteria are listed. By default, the fields that are present in the ICSR
Report are checked for the Duplicate Search.

For more information, see:

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

View duplicate search options

Field 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.
View ICSR Enables you to view the E2B report.
MIR Viewer Enables you to view the MIR report in XML and PDF formats.
View Differences
Reporter Displays the reporter involved with the case matching the search
criteria.
This field appears in the search results.

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Field Description
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.

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

The Duplicate Search in Argus Central Incoming review enables you to search on Reference
ID and Keyword field in Oracle Argus Safety cases.
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.

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Right-click Option Description

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.

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.

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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.
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.

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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.

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.

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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?
• 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.

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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.
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:

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• 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:
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

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• 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.
• 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.

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– 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.
• 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.

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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:
• 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

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• 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

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.

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To... Do...
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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Manage your periodic report submissions
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

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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.
– 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.

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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
– 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.

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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.
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.

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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.
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.

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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

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.

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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
• 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

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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.

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
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 remove it from the selected destination.

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Field Description
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
Destination 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.
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 Automatically displays the earliest license awarded date, when a user
Date 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
criteria on separate is printed. This is only available when PDF option is selected during
cover page printing.
Print page numbers When checked, this option enables the user to print page numbers on a
on 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 When the report is run as final, it creates a Hit List, which can be
report cases through retrieved from other areas of the application where advanced conditions
Case Series can be 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.

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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.

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.

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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.
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.

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Field Description
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
(Clinical Reference Study Reference is selected as a Data Element in the Available Data
Data Element) Elements 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 Check this option to allow cases that have not been locked for reporting to
Cases 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.

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).

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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
– 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.
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.

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• 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
from Cases/ Dictionary to populate the data from the MedDRA dictionary.
Dictionary
Print Only the Term Prints only the event Preferred Term (PT) or event Lower Level Term
(Preferred Term or (LLT) as per the selected radio button. Select the PT option to print only
Lower Level Term) the preferred term and not the verbatim description.
Print Dose Text in Prints the dosage and frequency information from Dose Description
place of regimen field instead of Regimen Dose.
dose
Indicate if case was This checkbox is selected if a primary agency has been selected in the
expedited previously Subject 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.
Print event info Select this checkbox to print the Seriousness, Listedness and
(Serious, Un-listed, Causality 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
under the primary only once under the Primary Event.
event
List cases under all Select this option to view the details of cases in the Main Line Listing
events, details under only once under the Primary Event, while non-primary events are listed
the primary event under their 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 Select this option to print Product Indication for the product selected in
Indication for the the report.
product selected 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.

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Field Description
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
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

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Field Description
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
Table a 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.
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
Tabulation type, 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 Allows a user to print CIOMS I forms for all Serious or Unlisted (Case
for serious/unlisted Level) cases appearing in the CTPR.
cases CIOMS contain Internal or Other text printed on them when the CTPR
is printed using the Internal or Other option.

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Field Description
Include Periodic Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1
Numbering on the of 2, A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to
CIOMS reports also contain the 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

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.

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

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Field Description
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
listings based on the set of cases tabulations/listings based on Case Data Analysis, Case listing
presented in the line listing or CIOMS II 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.
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
after selected end date report.
at xx:xx

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Field Description
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 Click this checkbox to share this report with other users. Specify the
with Other Users privileges 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.
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

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• 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

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.

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Field Description
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.
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.

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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.
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

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Field Description
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.

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.

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.

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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.
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
the primary event their 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.

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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 Create an index page of case numbers, for all cases included in the
Cases in PSUR PSUR.
Include Summary of This option creates a sub-report of cases missing one of the following
Cases Missing items:
Assessments • Seriousness
• 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
Tabulation Report type, Seriousness and Listedness of all cases in the PSUR.
Additional Expedited Allows you to print CIOMS/MedWatch/AERS forms (as per selection)
Report Forms for its respective regulatory agency (as selection), for all cases in the
(CIOMS/MedWatch/ report. It also provides an option to have (or not have) a watermark in
VAERS) the forms.

Include CIOMS reports

Field Description
Print CIOMS reports Allows a user to print CIOMS I forms for all Serious/Unlisted (Case
for serious/unlisted Level) cases appearing in the PSUR.
cases CIOMS contain Internal or Other text printed on them when the PSUR
is printed using the Internal or Other option.

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Field Description
Include Periodic Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1
Numbering on the of 2, A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to
CIOMS reports also contain the 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.
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.

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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.
Identify Spontaneous Allows you to select the study cases that use report type from the
Cases using Report multi-select list box. The values that are populated here, come from
Type 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
(UNION of rules below) Observe Study 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
Range for the events counted, and therefore should not overlap with the
current date range specified on the PSUR inclusion criteria tab.

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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.
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.

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Field Description
Generate Periodic ICSR submissions for Check this checkbox to generate the ICSR
cases that do not have at least one ICSR Reports only for the cases, where a Periodic ICSR
report scheduled during the reporting Report for the message type chosen, does not
period to any of the following Reporting exist.
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.
Modify Click Modify to select a different Reporting
Destination.
Generate Periodic ICSR submissions to Select a single-destination trading partner for
the following Reporting Destination Periodic 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 Allows you to select from pre-configured summary tabulations/listings.
summary tabulations/ These tabulations are based only on the data included in the line listing.
listings based on the Selecting the Exclude Follow-up Cases checkbox filters out follow-up
set of cases cases from the attached report.
presented in the line If the Exclude Follow-up Cases option is selected on the Inclusion
listing criteria tab, this option is ignored and follow-up cases are always filtered
out.
Include these Allows for additional sub-reports based on the Case Data Analysis
summary tabulations template, to be included as an output for the all cases in the database
based on all cases that meet the PSUR inclusion criterion for all dates.
Include these This option allows for additional sub-reports based on Case Data
summary tabulations/ Analysis, Case listing or CIOMS II line listing reports to be included as
listings based on the an output for the cases meeting the PSUR inclusion criterion for the
Date Range 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 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
Page Numbering for summaries.
UD Summaries (PDF
only)

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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.

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).

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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 Displays the list of configured Regulatory Agencies. Select an
Destinations 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.
Selected Reporting Displays the list of agencies where the report is being sent.
Destinations 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 Click this checkbox to print out the configuration of this report
on separate cover page when the report is printed. This is only available when the PDF
option is selected during printing.
Print page numbers on When checked, this option enables the user to print page
reports 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.

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Field Description
Allow access to report cases When the report is run as final, it creates a Hit List, which can
through Hit List be 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.
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.

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Field Description
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.
Report only Select this option to report only diagnosis events (only the diagnosis
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
under the primary only once under the Primary Event.
event System Organ
Class(SOC)
List cases under all Select this option to view the details of cases in the Main Line Listing
event System Organ only once under the Primary Event, while non-primary events are listed
Class (SOC) under their 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 Check this checkbox to separate death cases from the main IND listing.
for Death Cases If the 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.

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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
cases IND 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.

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.

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– 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
• 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.

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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
Destinations 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.
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.
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.

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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 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.
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.

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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 Enter the start date. This adds cases not included in a previous reporting
Included in a previous period with the specified start date.
reporting 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.

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
non-serious listed print 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.

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Field Description
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
Listing of 15 Day reports within the specified time period.
Reports Submitted The dates in these reports are in GMT.
TAB 3 Part 2: Check this checkbox to generate a tabulation by System Organ Class (SOC)
Tabulation by System of all events reported during the specified time period. This includes the
Organ Class (SOC) of cases for which expedited reports were previously generated, as well as the
All Event Reports cases that are submitted as part of the current report.
Submitted
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
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

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Field Description
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 Select this option to use periodic numbering on reports.
numbering on the
Reports
Custom Case Enter the Summary Report Title.
Summary 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
cases NDA 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.

Schedule the report

See Schedule the report.

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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 Displays the date when the case was nullified.
Date
Case Nullification Displays the reason entered when a case is logically deleted in Oracle
Reason Argus 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 > This option is displayed in the context menu only when PDF/CSV/DOCX
View 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.

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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.
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.

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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
• 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 Prints the report as Draft or Final. The Draft option is disabled when the
Report printing option is set to Transmit.
Select Medical Summary to view the list of only medical summaries of
distinct cases in a PDF.

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Field Description
Approved Reports Filters reports for only approved reports.
Only
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.

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.

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Field Description
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.

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 Allows the user to print the Medical Summaries.
Summary
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

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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.

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.

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Field Description
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.

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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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.

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FAQs

6. Click the link for a case number.

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.

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FAQs

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.

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

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What If

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.

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.

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What If

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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