CFR section
21 CFR 812.43(c): Selecting investigators and monitors
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart C-Responsibilities of Sponsors
Key facts
| Citation | 21 CFR 812.43(c) |
|---|---|
| Section | Selecting investigators and monitors |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart C-Responsibilities of Sponsors |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes: (1) The investigator's curriculum vitae. (2) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience. (3) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination. (4) A statement of the investigator's… |
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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.