Financial Disclosure by Clinical Investigators

The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

The latest form for Financial Disclosure by Clinical Investigators expires 2022-04-30 and can be found here.

Certification--54.4(a)(1) and (a)(2)--Form FDA 3454

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.