Entering and structuring data in reports

How to code, link, record, enter, and document data in VigiFlow.

Creating parent-child reports

Parent-child reports include additional fileds for parent information.

Linking related reports

It is possible to link two or more reports if they concern the same patient or a cluster of cases.

Recording information for reports from studies and clinical trials

Use the "Study information" tab.

Attaching additional documents to a report

Addtional documents must be of one of the supported file types and less than 15 MB.

Using the reporter address book

If the same reporter sends multiple reports, use the “Reporter address book”.

Recording patient information

Patient information is found primarily in the “Patient” section of reports.

Coding adverse event information

Coding adverse event information with MedDRA enables users to find reports in searches and queries and allows for computer processing of cases

Entering dechallenge and rechallenge information

Where and how to enter dechallenge and rechallenge information.

Coding drug information with WHODrug

Coding drugs and vaccines with WHODrug enables users to find reports in searches and queries and allows for computer processing of cases.

Documenting causality assessments

Casuality assessments can be documented in VigiFlow using several different methods.