CFR section
21 CFR 312.53(c)(1): Selecting investigators and monitors
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.53(c)(1) |
|---|---|
| Section | Selecting investigators and monitors |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (1) A signed investigator statement (Form FDA-1572) containing: (i) The name and address of the investigator; (ii) The name and code number, if any, of the protocol(s) in the IND identifying the study(ies) to be conducted by the investigator; (iii) The name and address of any medical school, hospital, or other research facility where the clinical investigation(s) will be conducted; (iv) The name and address of any clinical laboratory facilities to be used in the study; (v) The name and address… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.