Prepare EVDAS Data for Signal Detection

Perform signal detection on EudraVigilance Data Analysis System (EVDAS) data by extracting and loading the adverse event data in the form of electronic Reaction Monitoring Reports (eRMRs) and line listings. 

Prerequisites

Consider the following prerequisites:

• To perform signal analysis on EVDAS data in Signal, you must first enable EVDAS Data Import for Signal Detection.
• To perform signal detection on EVDAS data in the same PEC with other supported data sources, you must enable Multi-Source Signal Data Consolidation.

Extract Data from the EVDAS Database

Before you can prepare EVDAS data for signal detection in Safety Signal, you must follow your business processes to extract eRMR and line listing data from the EVDAS database.

Load EVDAS Data to Safety

After obtaining the data from the EVDAS database, follow the sections below to prepare and load the data into Safety for signal detection.

Prepare Data

Before loading the EVDAS eRMR and line listings data, you must do the following:

• Ensure the active substance in the eRMR and line listings exists in the Safety Substance library.
• Configure a Signal Reporting Period record for the Product Family that aligns with the substance in the eRMR and line listings. To do this, navigate to the Reporting Period tab and select Create. Ensure the Start Date and End Date fields match the eRMR and line listings reporting period.
• In both the eRMR and line listings file, add a first column, Signal Reporting Period ID. Populate this column using the applicable ID field value from the newly created reporting period.

Load EVDAS eRMR and Line Listings Data

To load EVDAS eRMR and line listings data to Safety, navigate to Business Admin (Quick Acess) > Load to use Vault Loader. Follow the steps in Vault Loader: Create, Update & Delete Object Records to load each file and consider the following when loading the EVDAS eRMR and line listings:

• For Object Type, select one of the following depending on the file you are loading:
  • EVDAS eRMRs (evdas_ermr_data__v)
  • EVDAS Line Listings (evdas_line_listing__v)
• For Action Type, select Create.
• Ensure the Signal Report ID in the eRMR and line listing file is mapped to the related reporting period ID field value.
• Ensure all remaining fields in the eRMR and line listing file are mapped to the corresponding fields in Vault.

Results: EVDAS eRMR

Vault imports the EVDAS eRMR and creates a new EVDAS eRMR Data record. Using the mapped Signal Report ID from the file, Vault sets the following fields on the EVDAS eRMR Data record:

• Signal Reporting Period
• Product Family or Aggregate Reporting Group

Results: EVDAS Line Listings

Vault imports the EVDAS line listings and creates a new EVDAS Line Listing record. Using the mapped Signal Reporting Period ID from the file, Vault sets the following fields on the EVDAS Line Listing record:

• Signal Reporting Period
• Product Family or Aggregate Reporting Group

Update the MedDRA Term

If you plan to run Signal Calculations on EVDAS data, you must set the appropriate MedDRA term on the EVDAS eRMR Data records: 

1. Navigate to EVDAS eRMRs > [EVDAS eRMR Data]. 
2. Select Edit.
3. In the MedDRA Term field, select an option from the drop-down or select the Advanced Search () icon to use filters and refine your search.

To update MedDRA terms in bulk, contact your Veeva Representative.

Next Steps

After preparing the EVDAS data, see the following resources:

• To learn about how Vault links EVDAS line listing cases to Safety Case versions, see Signal Detection Using EVDAS Data. 
• To learn about running calculations, creating Statistical Data records, and running alerts on EVDAS data, see the Signal Detection Overview. To perform these actions on EVDAS data, the EVDAS eRMR Data records must include a Reporting Period associated with a Product Family or Aggregate Reporting Group and a MedDRA Term.