FAERS & VAERS Reconciliation

Vault can generate Case listings to identify cases that are present in the FAERS or VAERS database and missing from Safety.

About FAERS and VAERS Reconciliation

Case linking and reconciliation reports help synchronize your pharmacovigilance (PV) database (Safety) with external databases, such as the FDA Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS). This process allows case data that was analyzed in external databases to be included in signal detection.

The reconciliation reports compare cases between Safety and the FAERS or VAERS database to ensure that applicable cases sent to the FDA from sources other than Safety also exist in your Safety Vault. To complete this comparison, Vault performs case linking, which links Cases in your Safety Vault with cases in FAERS and VAERS. If any cases are missing from your Safety Vault, you can generate a Workbench Report to identify them in a Case listing.

Prerequisites

You must have a Veeva Safety Workbench license to use this feature. After obtaining a license, your Admin must assign you to the Workbench Management security profile.

Generate Case Listings

To reconcile cases between Safety and FAERS or VAERS, you can generate Case listings from:

• Workbench Report Sets
• Ad-hoc Workbench Reports

Generate Case Listings from Workbench Report Sets

Workbench Report Sets use the following Workbench Report Definitions to generate Case listings for reconciliation:

• FAERS Case Reconciliation Summary (Excludes Cases found in Safety Database)
• VAERS Case Reconciliation Summary (Excludes Cases found in Safety Database)

These report definitions are managed by Veeva and cannot be edited. To generate Case listings for reconciliation:

1. Create a Workbench Report Set and add one (1) of the above definitions.
2. FAERS and VAERS reconciliation report definitions include predefined filters. Enter filter values according to your business needs using the following guidance:
   • For FAERS reconciliation reports, you must enter the following filter values in lowercase:
     • Substance Name
     • Brand Name
     • Generic Name
   • For VAERS reconciliation reports:
     • You must enter the following filter values in uppercase:
       • Vaccine Name
       • Manufacturer
       • Vaccine Type Code
     • You must enter the Manufacturer filter value exactly how it appears in the VAERS database.
     • If you enter a Vaccine Type Code filter value, this value must match the Vaccine Code as published in the VAERS Data Use Guide.
3. Generate reports from the Workbench Report Set. We recommend generating reports from Workbench Report Sets as opposed to standalone Workbench Report Definitions so these reports can be automatically scheduled.

Generate Case Listings from Workbench Reports

You can run ad-hoc Workbench Reports to generate Case listings for reconciliation. To do this, set up a Workbench Report using the following safety views and then run the report:

• Signal FAERS - Case Listing Principal View
• Signal VAERS - Case Listing Principal View

How Vault Performs Reconciliation

When you generate Case listings for reconciliation, Vault queries the FAERS or VAERS database for matching cases. For Vault to link a FAERS or VAERS case with a Safety Case, the following criteria must be met for:

FAERS

• The FAERS case receipt date (receiptdate) matches a Safety Case New Info Date.
• One (1) of the following matches must be found:
  • The FAERS case number (safetyreportid) matches any Case Identifier (Reference Number) of a Safety Case.
  • The FAERS case company number (companynumb) or authority number (authoritynumb) matches one (1) of the following on a Safety Case:
    • Worldwide UID (WWUID)
    • UID
    • External System UID
    • Case Identifier (Reference Number)

VAERS

• One (1) of the following matches must be found:
  • The VAERS case number (vaers_id) matches any Case Identifier (Reference Number) of a Safety Case.
  • The VAERS case company number (splttype) matches one (1) of the following on a Safety Case:
    • Worldwide UID (WWUID)
    • UID
    • External System UID
    • Case Identifier (Reference Number)

Matching is case-sensitive, for example, a WWUID of US-001-01USA001 will not match a case company number of us-001-01usa001.

After Vault generates a Case listing for reconciliation, you can review this output.