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 number of Cases that match report criteria. Vault generates tables for both initial and follow-up reports. |
| Appendix: Non-Primary Suspect Product Report | This report prints the number of Cases that match 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 NDA, ANDA, or BLA held by the applicant. |
| Appendix: List of Death Cases | This report prints the number of Cases that match report criteria.
This report lists all cases that were transmitted to the FDA during the reporting period as a 15 or non-15 day report, where the patient has died. |
You can also include nullified and voided Cases in 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:
- Navigate to Workbench > Ad-Hoc Reports.
- Select Create.
- 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 (
) icon to use filters and refine your search.
- Set up Workbench Report filters, layout, and advanced options (standard templates) as needed.
- Select Save.
- Run and download the PADER.
Note: For the PADER Summary of ADR from Postmarketing Sources report output, if a Case has multiple LLT Adverse Events that fall under the same PT, Vault counts the PT only once.