The regulations do not require that the investigator be a physician. Sponsors are required to select only investigators qualified by training and experience as appropriate experts to investigate the drug (21 CFR 312.53(a)). In the event the clinical investigator is a nonphysician, a qualified physician (or dentist, when appropriate) should be listed as a sub investigator for the trial and should be responsible for all trial-related medical (or dental) decisions.
