Financial Disclosure by investigators

FORM FDA 3454: Certification: Financial Interests and Arrangements of Clinical Investigators
Download link: www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf
The FDA regulations require that the applicant submit one completed Form 3454 for all clinical investigators certifying to the absence of financial interests and arrangements. The applicant may append a list of investigator names to Form 3454 for those investigators certifying that those investigators hold none of the identifiable disclosable financial arrangements.

For any clinical investigator for whom the applicant does not submit the certification, the applicant must submit a completed Form 3455 disclosing the financial interests and arrangements and steps taken to minimize the potential for bias.