21 CFR 312.60
§ 312.60 General responsibilities of investigators.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 312.60, § 312.60 General responsibilities of investigators, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86293
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.