FDA Report Formats | Veeva Vault Help

Vault supports compliant generation and submission of multiple FDA-specific formats, including:

Note: Vault generates only the FDA MedWatch 3500A form version configured by your Admin.

FDA MedWatch 3500A Data Mapping Considerations

The following list describes how Vault handles certain data while generating FDA MedWatch 3500A forms:

For events, diagnoses, indications, test names, and medical conditions, Vault Safety always populates the MedDRA Lowest Level Term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.

Note: Your Admin can configure your Vault to populate the MedDRA Preferred Term (PT) for adverse events instead of the LLT.

Dates are populated using the format dd-mmm-yyyy. Blank dates are populated as dashes (---).
Certain fields may be masked, depending on the blinding settings on the Case or masking settings on the Distribution.
Depending on your Admin’s configuration, open-label Products within blinded Studies may be unmasked.
When populating section C, Vault exports up to 20 suspect Case Products and 20 concomitant Case Products based on Rank. When Rank is blank, Vault uses the following priority order:
1. The earliest-created Company Products
2. The earliest-created External Products

Note: For FDA eMDR files, Vault exports up to 20 Case Products.

If a Case includes a Company Product with an unknown formulation, Vault determines the form sections to map to based on the Product Registrations within the Product Family:
- If all Registrations have a Registered As value of Drug, Vault considers the unknown formulation Product a drug and maps to section C
- If all Registrations have a Registered As value of Device, Vault considers the unknown formulation Product a device and maps to section D
- If Registrations have differing Registered As values, Vault maps to section C
Vault maps Case Products with an eligible Drug Role to form sections as follows:
- C. Suspect Products:
  - Company Products if the Product Type is not Device or OTC Device
  - Study Products if the Product Type is not Device
  - External Products if the Product Type is not Device
- D. Suspect Medical Device and H. Device Manufacturers Only:
  - Company Products if the Product Type is Device or OTC Device
  - Study Products if the Product Type is Device
  - External Products if the Product Type is Device
When generating the August 2024 version of the form, for Cases with Combination Products that have multiple device constituents:
- Vault populates the device constituent Case Product with the highest rank in section D and populates section D information for all other device constituents in the overflow pages. If Case Products are not ranked, Vault populates the earliest-created device constituent Case Product in section D.
- Vault considers all device constituents when populating section H.