Learn how to use signal detection for EVDAS data.
About EVDAS Signal Detection
Safety Signal can perform signal detection on data from the EudraVigilance Data Analysis System (EVDAS), an EMA regulatory database.
EVDAS provides data in different formats. Safety Signal uses the following formats:
- 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 WWUID, to help identify Cases.
Your Admin loads the EVDAS eRMRs and line listings into Vault Safety for signal detection in Vault Safety Signal.
Prerequisite
Before you can perform signal analysis on EVDAS data in Safety Signal, your Admin must enable EVDAS data import and prepare EVDAS data for signal detection.
How Vault Links the EVDAS Line Listings to a Safety Case
After your Admin loads the EVDAS eRMRs and line listings into Vault Safety, Vault attempts to link each line listing case to a Case version in Vault Safety using the Worldwide UID (WWUID). The following scenarios occur depending on the matching parameters:
WWUID Matches a Single Case in Vault 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 Vault 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 Vault 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.