FDA Report Formats

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

• FDA MedWatch 3500A (August 2024 Version)
• FDA MedWatch 3500A (October 2015 Version)
• FDA eMDR
• FDA E2B(R3)
• FDA VAERS E2B(R3)
• FDA E2B(R2)

FDA MedWatch 3500A Data Mapping Considerations

When generating FDA MedWatch 3500A forms, Vault populates certain data as follows:

• For coded events, diagnoses, indications, test names, and medical conditions, Vault populates the MedDRA Lowest Level Term (LLT). Otherwise, Vault populates the reported term.

• Dates appear in dd-mmm-yyyy format. Blank dates appear 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

August 2024 Version Device Data Mapping

When generating the August 2024 version of the form:

• If the Case Product on the Transmission is a device, Vault exports data for that product to sections D and H. If the Case includes any other devices, Vault exports each to separate FDA MedWatch 3500A forms.
  • For section G, if the Case is for a clinical trial Study, Vault populates fields G.4 and G.5 using the following priority:
    1. The Investigational New Drug (IND) Study Registrations with the FDA. If multiple IND registrations exist, Vault populates information from the earliest-created Study Registration.
    2. The Product Registration related to the Case Product on the Transmission.
• If the Case Product on the Transmission is blank:
  • Vault populates the device Case Product with the highest rank in section D, and populates section D information for all other devices in the overflow pages. If Case Products are not ranked, Vault populates the earliest-created device Case Product in section D.
  • 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.