---
kind: "section"
citation: "21 C.F.R. § 812.43"
title: "21"
number: "812.43"
heading: "Selecting investigators and monitors."
url: "https://uscodex.org/cfr/21/812.43"
---

# §812.43. Selecting investigators and monitors.

- (a) **Selecting investigators.** A sponsor shall select investigators qualified by training and experience to investigate the device.
- (b) **Control of device.** A sponsor shall ship investigational devices only to qualified investigators participating in the investigation.
- (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 commitment to—**
    - (i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA;
    - (ii) Supervise all testing of the device involving human subjects; and
    - (iii) **Ensure that the requirements for obtaining informed consent are met.**
  - (5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under [part 54](/cfr/21/part54.md) of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. This information shall not be submitted in an investigational device exemption application, but shall be submitted in any marketing application involving the device.
- (d) **Selecting monitors.** A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable FDA regulations.

## Notes

### Amendments

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]

### Authority

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

### Amendments

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]