Learn how to prepare EVDAS data to perform signal detection in Safety Signal.
About EVDAS Signal Detection
With Safety Signal, you can load the adverse event data downloaded from the EudraVigilance Data Analysis System (EVDAS), an EMA regulatory database, for signal detection.
You can load this data into Vault Safety in the form of electronic Reaction Monitoring Reports (eRMRs) and line listings.
For more information, see Signal Detection Using EVDAS Data.
Prerequisite
To perform signal analysis on EVDAS data in Safety Signal, you must first enable EVDAS data import for signal detection.
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 Vault Safety
After obtaining the data from the EVDAS database, follow the sections below to prepare and load the data into Vault 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 Vault 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 Vault 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.
Consider the following when loading the EVDAS eRMR and line listings:
- For Object Type, select one (1) 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
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