Question: who has ultimate responsibility for an investigational product at the study site?
Answer: 1: “Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.” However, the sponsor is not off the hook, since the sponsor must ensure that the investigator is maintaining compliance with the regulations (21 CFR 812.40, 21 CFR 312.50), which of course, ...