§ 312.60. General responsibilities of investigators.
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/us/cfr/t21/s§ 312.60·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]
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§ 312.60
General responsibilities of investigators.
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