Clinical investigator

The definition is used to decide whose financial interests the applicant must certify or disclose under 21 CFR 54, and it includes spouses and dependent children. It is narrower than the general term investigator.

Clinical investigator means only a listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator.

21 CFR, 54.2