21 CFR Part 54 - Financial Disclosure by Clinical Investigators

What it says

Applicants submitting a marketing application that includes clinical studies must submit certification or disclosure of financial interests and arrangements between the sponsor and the clinical investigators, such as compensation tied to the outcome of the study or significant equity interests. Investigators must provide the information to the sponsor, and sponsors must keep records and update disclosures when needed.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The aim is to let FDA assess whether financial interests might bias a study.
• Investigators need to be asked for the information at the start and for a period after the study.
• Disclosure covers arrangements that could affect the study, not only large payments.

What FDA inspectors look for

• Whether financial information was collected from each investigator.
• Whether certification and disclosure forms are complete.
• Whether records are retained for the required period.

Related regulations