D.C. Mun. Regs. tit. 22, r. 22-B10916

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10916 - SELECTING INVESTIGATORS AND MONITORS

10916.1

A sponsor shall select investigators qualified by training and experience to investigate the device.

10916.2

A sponsor shall ship investigational devices only to qualified investigators participating in the investigation.

10916.3

A sponsor shall obtain from each participating investigator a signed agreement that includes:

(a) The investigator's curriculum vitae;

(b) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience;

(c) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination;

(d) A statement of the investigator's commitment to:

(1) Conduct the investigation in accordance with the agreement, the investigational plan, this section and other applicable Department regulations, and conditions of approval imposed by the reviewing IRB or the Department;

(2) Supervise all testing of the device involving human subjects; and

(3) Ensure that the requirements for obtaining informed consent are met; and

(e) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 C.F.R., part 54. 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 one (1) year following completion of the study. This information shall not be submitted in an IDE application, but shall be submitted in any marketing application involving the device.

10916.4

A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable Department regulations.

D.C. Mun. Regs. tit. 22, r. 22-B10916

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.