Financial disclosure by clinical investigators (21 CFR 54.1-54.6).

Part 54 of Title 21 of the Federal Code of Regulations defines the financial disclosure by clinical investigators in terms of administrative procedures regarding the clinical studies aimed to determine whether the applications are approvable under the statutory requirement (also for biological products and including the potential increase in the value of the interest if a specific product is approved).
The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications under the terms of this Regulation.