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21 CFR Part 312 · Investigational New Drug Application

§ 312.60 General responsibilities of investigators

Subpart D - Responsibilities of Sponsors and Investigators Official text on eCFR Amendment history

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 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 312.60

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Bioresearch Monitoring).

  • FD-1572, protocol compliance 1,990
  • Informed consent 180

Warning letters citing § 312.60

54 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 312.60

Amendment history

Federal Register documents that created or amended this section.