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
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. See Enable Export Product (Reported) to CIOMS I and FDA 3500A for details on setting the default value for export.
- 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. Generate Masked Distributions describes the fields that may be masked.
- Open-label Products within blinded Studies may be unmasked, depending on your Admin’s configuration of Show Unmasked Open-Label Products on Blinded Forms
- When populating Section C. Suspect Products, 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:
- The earliest-created Company Products
- 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. Suspect Products
- If all Registrations have a Registered As value of Device, Vault considers the unknown formulation Product a device and maps to Section D. Suspect Devices
- If Registrations have differing Registered As values, Vault maps to Section C. Suspect Products
- Vault maps Case Products with an eligible Drug Role to form sections as shown in the following table:
| Case Product Type | Product Type | Sections |
|---|---|---|
| Company Product |
|
D. Suspect Medical Device H. Device Manufacturers Only |
| Company Product |
|
C. Suspect Products |
| External Product | Device | D. Suspect Medical Device H. Device Manufacturers Only |
| External Product | Any type other than Device | C. Suspect Products |
| Study Product | Device | D. Suspect Medical Device H. Device Manufacturers Only |
| Study Product | Any type other than Device | C. Suspect Products |
Optional Configuration
To evaluate Case Products with the Drug Role of Drug Not Administered as suspect, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Vault evaluates only Case Products with a Drug Role of Suspect or Interacting as suspect.