CFR section
21 CFR 312.60: General responsibilities of investigators
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.60 |
|---|---|
| Section | General responsibilities of investigators |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | 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… |
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