Create Workbench SAR Reports

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

About Workbench SARs

Vault Safety Workbench provides Serious Adverse Reactions (SAR) authoring and table generation capabilities.

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

Tabulation Description
SAR Line Listing This report prints the Case listings for SAR occurrences that match report criteria.
SAR Tabulation by PT This report prints the Case listings for SAR occurrences that match report criteria, organized by the MedDRA Preferred Term (PT).
SAR Tabulation by SOC, PT This report prints the Case listings for SAR occurrences that match report criteria, organized by the MedDRA System Organ Class (SOC) and then by the Preferred Term (PT).

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

Prerequisites

To generate Workbench SAR reports, you must contact Veeva Support and your Admin must configure Workbench SAR reports.

Create a Workbench SAR Report

To create a Workbench SAR report:

  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 SAR view from the drop-down or use the Advanced Search (binoculars-icon) icon to use filters and refine your search.
  4. Set up Workbench Report filters, layout, and advanced options (standard templates) as needed.
  5. Select Save.
  6. Run and download the SAR report.