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).
SUSAR Line Listing This report prints the Case listings for SUSAR (suspected unexpected serious adverse reaction) occurrences that match report criteria.

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

SAR Criteria

Vault uses the SAR Principal view to assess each Case. To qualify for the SAR report, each returned Case must meet the following criteria:

  • One (1) of the following are met:
    • Contains at least one (1) Product defined by the product filter in the SAR Principal view.
    • Contains at least one (1) Study defined by the study filter.
  • One (1) of the following are met:
    • Report Type is set to Study (E2B Code=2) and Study Type is set to Clinical Trial (E2B Code=1).
    • Report Type is set to Study (E2B Code=2), Study Type is left blank or is set to a non-valid E2B value, and Literature is not set to Yes.
  • Contains at least one (1) SAR. This is when at least one (1) event on the Case is serious and related to a Study Drug Role of IMP, Comparator, Placebo, or blank.

SUSAR Criteria

A SUSAR report provides a more specific subset of SAR data. To qualify for the SUSAR report, a Case must have at least one (1) Adverse Event that meets the following criteria:

  • Is unlisted: Vault does the following to determine listedness:
    1. Identifies the relevant datasheet for the Case by ensuring the values for the following fields match between the datasheet and the Case Adverse Event:
      • MedDRA Term
      • Active Start Date
      • Active End Date
    2. Identifies the Case as listed if at least one (1) MedDRA Term on the datasheet is expected. Vault identifies the Case as unlisted if all matching MedDRA Terms are unexpected.
  • Is serious: Vault identifies an event as serious when the Seriousness field on the Case Adverse Event record is populated.
  • Is related to the suspect Product: Vault identifies a Case Adverse Event as related to a Case Product when any Case Assessment Result for this pair has Causality Established set to Yes or blank.

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.