FDA Report Formats

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

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.
  • 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
  • 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.