21 CFR 312.60: General responsibilities of investigators
Requires clinical investigators to conduct studies per the signed statement, investigational plan, and regulations, protect subjects' rights, safety, and welfare, control the investigational drug, and obtain informed consent from each subject.
Part 312, Investigational New Drug Application · Subpart D, Responsibilities of Sponsors and Investigators
How FDA words it
The opening lines investigators use most when they cite 312.60, from the 483s we hold.
An investigation was not conducted in accordance with the investigational plan.Most used
An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Cited over time
483s citing 312.60, by yearMost citations in 2026 so far. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2026.
Recent 483s citing 312.60
- Prithviraj Bose, M.D. M.D. Anderson Cancer Center, Department · Houston, TexasAn investigation was not conducted in accordance with the signed statement of… Apr 30, 2026
- Form 483 · FEI 3043365433 · Saginaw, MichiganAn investigation was not conducted in accordance with the investigational plan… Apr 24, 2026
- Form 483 · FEI 3042366712 · Phoenix, ArizonaAn investigation was not conducted in accordance with the signed statement of… Mar 13, 2026
- Dennis J. Hsu, M.D · Pittsburgh, PennsylvaniaAn investigation was not conducted in accordance with the signed statement of… Mar 3, 2026
- Prof. Bernardo Leon Rapoport · Johannesburg, South AfricaAn investigation was not conducted in accordance with the investigational plan… Jan 29, 2026
The regulation text
§ 312.60 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall obtain the informed consent of each human subject to whom the drug is administered, in accordance with part 50 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.
[88 FR 88248, Dec. 21, 2023]
Questions
What does 21 CFR 312.60 require?
Requires clinical investigators to conduct studies per the signed statement, investigational plan, and regulations, protect subjects' rights, safety, and welfare, control the investigational drug, and obtain informed consent from each subject.
How do FDA investigators word a 312.60 observation?
The most common opening is: “An investigation was not conducted in accordance with the investigational plan.”
Which sections are cited alongside 312.60?
In the same 483s, investigators most often also cite 312.62 (Investigator recordkeeping and record retention), 312.66 (Assurance of IRB review), 50.20 (General requirements for informed consent), 312.64 (Investigator reports).