Signal can support Product-Event Combinations (PECs) from the EudraVigilance Data Analysis System (EVDAS), an EMA regulatory database.
EMA provides data in the following formats available for download from the EVDAS portal:
- Electronic Monitoring Reports (eRMRs): This report includes statistical scores and report counts, for example, the total number of serious Cases.
- Line Listings: This table accompanies the eRMR and is a list of Individual Case Safety Reports (ICSRs) that contributed to the Case counts and statistical scores in the eRMR. Information also includes other important values, such as adverse event reactions and the Worldwide UID (WWUID), to help identify Cases.
Your Admin loads the EVDAS eRMRs and line listings into Safety for signal detection in Signal.
Prerequisites
Consider the following prerequisites:
- Before you can perform signal analysis on EVDAS data in Signal, your Admin must enable EVDAS data import and prepare EVDAS data for signal detection.
- To perform signal detection on EVDAS data in the same PEC with other supported data sources, your Admin must enable Multi-Source Signal Data Consolidation.
How Vault Links the EVDAS Line Listings to a Safety Case
After your Admin loads the EVDAS eRMRs and line listings into Safety, Vault attempts to link each line listing case to a Case version in Safety using the WWUID. The following scenarios occur depending on the matching parameters:
WWUID Matches a Single Case in Safety
If the EVDAS Line Listing WWUID matches a single Case, Vault sets the latest related Case Version and Case Number fields on the EVDAS Line Listing record.
WWUID Matches Multiple Cases in Safety
If the EVDAS Line Listing WWUID matches multiple Cases with different Case numbers, Vault chooses the latest Case version based on the Case record with the most recent creation date. Vault then sets the latest related Case Version and Case Number fields on the EVDAS Line Listing record.
WWUID Does Not Match
If the EVDAS Line Listing WWUID does not match any Case records, Vault does not link the EVDAS Line Listing case to any Case in Safety.
Next Steps: Create Safety Investigations from EVDAS eRMR Records
For Product-Event Combinations (PECs) that require further investigation, you can create a Safety Investigation from the EVDAS eRMR record.