Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 312 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 312 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 — Unit 2.3.1 |
| Scope | HM |
| Document part | § 312.60 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, Safety, Investigator, FDA |
Content
§ 312.60 General responsibilities of investigators.
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.
