Learn how Vault generates the FDA MedWatch 3500A form from a Case. Depending on your Admin’s configuration, Vault generates FDA MedWatch 3500A forms using either the August 2024 or October 2015 version. Review the following articles to learn how Vault maps information to generate FDA MedWatch 3500A forms:
- FDA MedWatch 3500A (August 2024 Version) Generation Mapping
- FDA MedWatch 3500A (October 2015 Version) Generation Mapping
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
- Case Products with a Drug Role of Suspect, Interacting, or Drug Not Administered are mapped 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.