Import EVDAS Data

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

Preparing EVDAS data for signal detection involves extracting the data in CSV (UTF-8) format from the EVDAS database and importing the data to Signal for:

After importing EVDAS data, Vault attempts to match each case listing to a Case in your Vault.

Prerequisites

Consider the following prerequisites:

Complete Routine Data Requests

To allow users to review EVDAS data at predetermined intervals, create routine Signal Data Requests for Signal Reporting Periods and import EVDAS data to these records:

  1. Follow your business processes to extract eRMR or line listing data from the EVDAS database in CSV (UTF-8) format for the required reference period.
  2. Navigate to the Reporting Periods tab and select the Signal Reporting Period to which you want to import the EVDAS data for routine review. 
  3. Expand the Data Requests section and select Create.
  4. In the Create Signal Data Request window, complete the applicable fields.
  5. From the Workflow State Change menu (Workflow-State-Button), select Change State to In Progress.
  6. In the left panel, select Request Files and then select Create.
  7. In the Create Signal Data Request File window, complete the following fields to import the eRMR or line listing:
    • Request Data Source: From the drop-down, select EMA - EVDAS. 
    • Import File Format: From the drop-down, select eRMR or Line Listing. 
    • Import File: Select the Upload icon or drag and drop the appropriate file to this field. 
  8. Select Save or Save + Create to create additional Signal Data Request Files for the Signal Data Request as needed.
  9. From the All Actions menu of the Signal Data Request, select Import EVDAS Data. If the import results in any errors or warnings, address them before proceeding. See the results to learn what happens after this action runs and the considerations when triggering this action.
  10. From the Workflow State Change menu, select Change State to Complete. 

After creating routine Signal Data Requests, learn more about performing signal detection on EVDAS data and configuring your Vault accordingly. 

Complete Ad-Hoc Data Requests

Users may submit ad-hoc requests for EVDAS data at any time, for example, as part of a Safety Investigation validation step. To import EVDAS data for ad-hoc Signal Data Requests:

  1. Navigate to the Data Requests tab, if configured, and select the Signal Data Request.
  2. In the applicable Signal Data Request, from the Workflow State Change menu, select Change State to In Progress.
  3. Follow your business processes to extract eRMR or line listing data from the EVDAS database in CSV (UTF-8) format for the given reference period.
  4. In the left panel, select Request Files and then select Create.
  5. In the Create Signal Data Request File window, complete the following fields to import the eRMR or line listing: 
    • Request Data Source: Vault populates this field based on the parent Signal Data Request.
    • Import File Format: From the drop-down, select eRMR or Line Listing. 
    • Import File: Select the Upload icon or drag and drop the appropriate file to this field. 
  6. Select Save or Save + Create to create additional Signal Data Request Files for the Signal Data Request as needed.
  7. From the All Actions menu of the Signal Data Request, select Import EVDAS Data. If the import results in any errors or warnings, address them before proceeding. See the results to learn what happens after this action runs and the considerations when triggering this action. 
  8. From the Workflow State Change menu, select Change State to Complete to let the user who sent the request know that the EVDAS data is ready for review.

After triggering the Import EVDAS Data action on the Signal Data Request, Vault creates an EVDAS eRMR Data record for each row in the eRMR file and an EVDAS Line Listing record for each row in the line listing file. For each imported eRMR file, Vault codes the MedDRA PTs using the active MedDRA version in your Vault. If there’s no match, Vault attempts to code the term using the latest version loaded to your Vault, followed by the highest version available. If Vault fails to autocode the PT, navigate to the EVDAS eRMR Data record and manually code the MedDRA Term.  

After triggering the Link EVDAS eRMRs and Line Listings action on the Signal Data Request, Vault links any eRMRs and line listings that match on the following fields:

  • The eRMR Active Substance and a line listing substance from the Suspect/Interacting Drug List or the Concomitant/Not Administered Drug List
  • The eRMR PT and the line listing Reaction List PT

Vault cross-links matching EVDAS eRMR Data records and EVDAS Line Listing records.

EVDAS Import Considerations

When triggering the Import EVDAS Data action, adding duplicate eRMR or line listing files to the Signal Data Request results in duplicate imports and record creation. Vault does not remove duplicate files. 

For eRMR and line listing files in the Error or Imported with Warning state, Vault creates a CSV for each file to capture the errors and warnings and attaches it to the Import File Log Data field on the respective Signal Data Request File. Consider the following scenarios that result in: 

  • Errors: 
    • Missing file data for required fields
    • The CSV cell data exceeds the object field character limit 
    • The data type does not match between a CSV cell and an object field, for example, the cell value is text and the corresponding field requires numbers 
  • Warnings: 
    • The line listing CSV includes truncated cells (fields ending in ellipses) for one of the following: 
      • Literature Reference
      • Reaction List PT
      • Suspect/interacting Drug List
      • Concomitant/Not Administered Drug List 
    • Vault cannot autocode the MedDRA PT for the eRMR

Vault uses the following logic to set the lifecycle state on both the Signal Data Request and the Signal Data Request Files after import:

  • Imported: There are no errors or warnings in the eRMR or line listing file.
  • Error: There is at least one error in the eRMR or line listing file.
  • Imported with Warning: There are no errors but there is at least one warning in the eRMR or line listing file.

Address Errors & Warnings

Errors or warnings may occur after importing eRMR and line listing files to a Signal Data Request or when attempting to link these corresponding records together. 

Address Import Errors & Warnings

To address the errors and warnings in eRMR and line listing files: 

  1. In the applicable Signal Data Request, delete the created EVDAS eRMR Data and EVDAS Line Listing records linked to the Signal Data Request File in Error or Imported with Warning state. 
  2. In the Request Files section, select the file in the Error or Imported with Warning state.
  3. From the Import File Log Data field, download and open the CSV file.
  4. To address errors and warnings: 
    • Errors: You can edit the file directly or delete the imported file if there is an issue with the CSV itself. 
    • Warnings: For line listing CSVs with truncated cells, navigate to the Individual Case Safety Reports (ICSRs) for the full list of drugs and terms and then edit the CSV cells as applicable; if you do not have access to the ICSRs, you may need to obtain this report from the FDA. For eRMR MedDRA coding issues, you can manually code the MedDRA Term. 
  5. For routine or ad-hoc Signal Data Requests, follow the steps to re-import the files and complete the data request.

For files in the Error or Imported with Warning state, re-importing files to the Signal Data Request resets the lifecycle state of the Signal Data Request and the Signal Data Request Files to Importing. 

Address Linking Errors

When Vault cannot link the eRMR and line listing after triggering the Link EVDAS eRMRs and Line Listings action, Vault sets the Signal Data Request to the Linking Error lifecycle state and attaches a CSV capturing the errors to the Attachments section. To address the linking errors: 

  1. In the Signal Data Request, expand the Attachments section.
  2. Download the CSV file. 
  3. Review and address errors as necessary. 
  4. For routine or ad-hoc Signal Data Requests, follow the steps to link corresponding eRMR and line listing files together.