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Vigiflow: Introduction and Basic Features

VigiFlow is a web-based pharmacovigilance database system that supports the collection, processing, analysis, and sharing of adverse drug reaction and adverse event following immunization reports. It has improved data entry options, can capture information using several causality assessment methods, and allows access to analysis tools. VigiFlow transitions countries from older systems and is compatible with international standards. It includes features like online reporting, import/export of data, and access control levels for different users.

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Eris Seiren
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790 views26 pages

Vigiflow: Introduction and Basic Features

VigiFlow is a web-based pharmacovigilance database system that supports the collection, processing, analysis, and sharing of adverse drug reaction and adverse event following immunization reports. It has improved data entry options, can capture information using several causality assessment methods, and allows access to analysis tools. VigiFlow transitions countries from older systems and is compatible with international standards. It includes features like online reporting, import/export of data, and access control levels for different users.

Uploaded by

Eris Seiren
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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VigiFlow

Introduction and basic features

Updated October 2019


Disclaimers

This material is based on the latest version of VigiFlow, released in May


2020. Some features are still under development, therefore the system
appearance might differ from the slides included in this package.

This PowerPoint presentation has been developed by the UMC for


training purposes. This material may be passed on to other users of
VigiFlow.

The UMC does not take any liability for the correctness or quality of
any altered, translated or partial versions of this material.
What is VigiFlow?

VigiFlow is a web-based ICSR data management


system

It is your country’s own national pharmacovigilance


database which supports the collection,
processing, analyzing and sharing of ADR and AEFI
reports.
Transitioning from the old VigiFlow...
... to VigiFlow
Main features of VigiFlow

 Compatible with updated international standards (ICH-


E2B(R3))
̶ MedDRA is the medical terminology

 Improved data entry options for ADR and AEFI reports


̶ e.g. enter multiple dosage info for same drug or vaccine
̶ Possible to capture 25 AEFI core variables

 Possible to capture causality assessment results from


different methods:
̶ WHO-UMC causality; Naranjo; WHO AEFI; The French method

 Direct access to VigiLyze


Additional features in VigiFlow

Manual data entry Interface and Import and export Different access Online form for
medical of xml files for levels that will data entry for
terminology in exchange of ICSRs enable multiple PV pharmaceutical
Direct reporting for English, French, between the NC centers to report industries and
patients and Portuguese and and other ICSRs directly into public health
healthcare Spanish stakeholders (e.g. the national programs
professionals pharmaceutical database
(eReporting) industries)

* Features are under development and will be implemented in the upcoming months
Standardized terminologies in VigiFlow

MedDRA is the only medical terminology available in VigiFlow. It can be used to add
adverse reactions, drug indication, medical history, cause of death, test names and
diagnosis. For further information about MedDRA, go to https://www.meddra.org/.

WHODrug is the dictionary embedded in VigiFlow for finding drug names or active
substances. For further information about WHODrug, go to https://who-
umc.org/whodrug/whodrug-portfolio/.

Both terminologies are automatically updated whenever a new version is released.


How to access VigiFlow

• Recommended web browser: Google Chrome

• Web address: https://vigiflow.who-umc.org

• Questions: [email protected]
Login page
Terms and Conditions for the use of VigiFlow

At the first login, the user will be prompted to read and accept the Terms and Conditions
for using VigiFlow to be able to use the system.
Main screen – Report List

After logging into VigiFlow, you get directly into the Report List
Information displayed at the top bar
The name of your country´s national
The name of the page in pharmacovigilance centre The name of the person
which you are current located logged into VigiFlow
Information displayed at the bottom bar

UMC logo is clickable and will If your computer is enabled, by By clicking Help, you will be directed
MedDRA version currently
direct you to the UMC website clicking Contact a blank e-mail to VigiFlow page at the UMC
implemented in VigiFlow
(www.who-umc.org) message will open up automatically website, where you can find
directed to [email protected]. technical documents and training
You can use this e-mail address for materials.
any inquiries regarding VigiFlow.
Language settings

By clicking in the username, it is possible to change the language in VigiFlow.


Choosing the language

Choose the language you want to use


NOTE! The same language is set for the interface and medical terminology, which means
that it is not possible to have the system in one language and use MedDRA in a different
language.
eReporting
eReporting: add-on to VigiFlow

eReporting is a standardized online ADR reporting form developed by the UMC


to facilitate electronic reporting from patients and healthcare professionals
▪ Reports go directly into VigiFlow without delay
▪ Information is automatically placed in the corresponding fields
▪ Minor manual data entry left for the PV centre
eReporting fields (1/3)
eReporting fields (2/3)
eReporting fields (3/3)
Connection between eReporting and
VigiFlow

When a new case is reported in eReporting, it automatically shows in the list of


reports as seen below.
If the drug names are recognized by the WHODrug dictionary, they are
automatically coded.

Reaction is blank
Drug name is auto-mapped
Auto-mapping of information entered in
eReporting

Reports received through eReporting require less manual data entry because
information entered in the eReporting online form are automatically transferred to the
corresponding field in VigiFlow.
Identifying reports received via eReporting –
Search filters

These reports are also identifiable through the Means of reporting, available
as a search filter and a column in the Excel export.
Identifying reports received via eReporting –
Excel export

These reports are also identifiable through the Means of reporting, available
as a search filter and a column in the Excel export.

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