Yes. Under 21 CFR Part 54 (Disclosure of Financial Interests by Clinical Investigators),
a person listed or identified as an investigator or sub investigator who is directly involved
in the treatment or evaluation of research subjects must submit financial disclosure
information to the sponsor. For purposes of this financial disclosure regulation, the term
investigator also includes the spouse and each dependent child of the investigator and
subinvestigator. (21 CFR 54.2(d) and 54.4). For additional information about financial
disclosure, see FDA’s Guidance for Industry Financial Disclosure by Clinical
Investigators.
