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 summary report includes the active substance, and 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.
As part of routine signal surveillance, your Admin can create a Signal Data Request to import EVDAS data for a Signal Reporting Period. As part of an ad-hoc review, you can create a Signal Data Request for a Safety Investigation.
Prerequisites
Consider the following prerequisites:
- Before you can perform signal analysis on EVDAS data in Signal, your Admin must enable EVDAS data import and import 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.
Request EVDAS Data
To review EVDAS data outside of a routine schedule, for example, as part of a Safety Investigation validation step, create an ad-hoc Signal Data Request from a Safety Investigation:
- Navigate to the Safety Investigations tab and select the Safety Investigation to which you want to import EVDAS data for an ad-hoc review.
- Expand the Data Requests section and select Create.
- In the Create Signal Data Request window, complete the applicable fields.
- From the Workflow State Change menu (
), update the Signal Data Request lifecycle state to Open. - After your Admin completes your request and imports EVDAS data, you can review it from the Safety Investigation.
After EVDAS data import, Vault attempts to match each case listing to a Case version in your Vault.
Signal Data Request Fields
The following fields may be available:
| Field | Description |
|---|---|
| Safety Investigation | When creating the Signal Data Request from a Safety Investigation, Vault populates this field. Otherwise, select a Safety Investigation from the drop-down or select the Advanced Search ( ) icon to use filters and refine your search. |
| Reporting Period | When creating the Signal Data Request from a Signal Reporting Period, Vault populates this field. Otherwise, select a reporting period from the drop-down or select the Advanced Search icon to use filters and refine your search. |
| Request Purpose | Select the purpose for your request from the picklist. |
| Request Priority | Select the priority of this request from the picklist. |
| Reference Period Start Date | When you populate the Reporting Period field, Vault populates the start date of the Signal Reporting Period. For ad-hoc requests, enter the search criteria start date. |
| Reference Period End Date | When you populate the Reporting Period field, Vault populates the end date of the Signal Reporting Period. For ad-hoc requests, enter the search criteria end date. |
| Request Data Source | Select EMA - EVDAS from the drop-down. |
| Due Date | Select the date this request is due from the calendar or enter the date manually. |
| Request Summary | Provide additional details about the data request as needed, for example, if you are requesting either or both eRMR data and case line listing data, or specific MedDRA terms. |
Note: Vault supports automated Signal Data Requests for the EVDAS database only. Support for additional data sources will be available in a future release.
How Vault Links the EVDAS Line Listings to a Safety Case
After your Admin imports EVDAS line listings to Signal, Vault attempts to link each case listing to a Case version in your Vault 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.