21 CFR 312.50: General responsibilities of sponsors
Requires sponsors to select qualified investigators, give them needed information, monitor studies, ensure conduct follows the IND plan and protocols, maintain an effective IND, and promptly inform FDA and investigators of significant new risks.
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 312.50, from the 483s we hold.
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.Most used
Cited over time
483s citing 312.50, 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 312.50
- Abbisko Therapeutics Co., Ltd. · Pudong New Area, ChinaFailure to ensure the study is conducted in accordance with the protocol and/or… Mar 20, 2026
- Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200 · Brisbane, CaliforniaFailure to provide investigators with the information needed to conduct the study… Mar 2, 2026
- BeOne Medicines USA, Inc. · Pennington, New JerseyFailure to ensure the study is conducted in accordance with the protocol and/or… Feb 17, 2026
- BioEclipse Therapeutics, Inc. · —Failure to ensure proper monitoring of the study and ensure the study is conducted… Mar 25, 2025
- Genentech, Inc. · South San Francisco, CaliforniaFailure to ensure proper monitoring of the study and ensure the study is conducted… Mar 12, 2024
The regulation text
§ 312.50 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.
Questions
What does 21 CFR 312.50 require?
Requires sponsors to select qualified investigators, give them needed information, monitor studies, ensure conduct follows the IND plan and protocols, maintain an effective IND, and promptly inform FDA and investigators of significant new risks.
How do FDA investigators word a 312.50 observation?
The most common opening is: “Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.”
Which sections are cited alongside 312.50?
In the same 483s, investigators most often also cite 312.20 (Requirement for an IND), 312.57 (Recordkeeping and record retention), 312.60 (General responsibilities of investigators), 312.62 (Investigator recordkeeping and record retention).