Create Workbench PADER Aggregate Reports

Learn about PADER aggregate reports in Safety Workbench and how to generate them.

About Workbench PADERs

Vault Safety Workbench provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.

The following table summarizes the PADER tabulations that Safety Workbench generates:

Tabulation Description
15 Day and Non-15 Day Summary Reports This report prints the number of Case Adverse Events that match report criteria. Vault generates tables for both initial reports and follow-up reports.
Summary of ADR from Postmarketing Sources This report prints the number of Case Adverse Events that match report criteria.
Interval Line Listings This report prints the Case listing that matches report criteria. Vault categorizes Case listings by initial and follow-up reports, seriousness, listedness, and whether the report was expedited.
Cases Submitted under other NDA's This report prints the Case listing that matches report criteria.

This report is a summary listing of the Adverse Events in which the drug or biological Product was listed as one (1) of the suspect Products, but the report was filed to another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA) held by the applicant.

You can also include nullified and voided Cases in Workbench PADER aggregate reports.

If at least one (1) reportable Product Registration on the Case matches that of the Aggregate Reporting Group, Vault includes this Case in one (1) of the following reports:

  • 15 Day and Non-15 Day Summary Reports
  • Summary of ADR from Postmarketing Sources
  • Interval Line Listings

If the Product Registration on the Case does not match that of an Aggregate Reporting Group, Vault includes the Case in the Cases Submitted under other NDA’s report. For more information about how Vault identifies Cases as submitted under another NDA, ANDA, or BLA, see Configure Workbench PADER Aggregate Reports.

Prerequisites

To generate Workbench PADERs, you must contact Veeva Support and your Admin must configure Workbench PADER aggregate reports.

Create a Workbench PADER

To create a Workbench PADER:

  1. Navigate to Workbench > Ad-Hoc Reports.
  2. Select Create.
  3. Complete the following information:
    • Name: Enter a name for this report.
    • Workbench View: Select a PADER view from the drop-down or use the Advanced Search (saf-binoculars-icon) icon to use filters and refine your search.
  4. Set up Workbench Report filters, layout, and advanced options (standard templates) as needed.
    For PADERs, you must set a value for the Aggregate Reporting Group filter to define the Product Registrations and Study Registrations that will be included on the Workbench aggregate report. For more information about Aggregate Reporting Groups, contact your Admin.
  5. Select Save.
  6. Run and download the PADER.