CFR section
21 CFR 812.110(d): Specific responsibilities of investigators
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart E-Responsibilities of Investigators
Key facts
| Citation | 21 CFR 812.110(d) |
|---|---|
| Section | Specific responsibilities of investigators |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart E-Responsibilities of Investigators |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (d) Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. |
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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.