D.C. Mun. Regs. tit. 22, r. 22-B10908

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

Rule 22-B10908 - INVESTIGATIONAL PLAN

10908.1

The investigational plan shall include, in the following order:

(a) The name and intended use of the device and the objectives and duration of the investigation;

(b) A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound;

(c) A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition;

(d) A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation;

(e) The sponsor's written procedures for monitoring the investigation and the name and address of any monitor;

(f) Copies of all labeling for the device;

(g) Copies of all forms and informational materials to be provided to subjects to obtain informed consent;

(h) A list of the names, locations, and chairpersons of all IRBs that have been or will be asked to review the investigation, and a certification of any action taken by any of those IRBs with respect to the investigation;

(i) The name and address of each institution at which a part of the investigation may be conducted that has not been identified in § 10908.1(h); and

(j) A description of records and reports that will be maintained on the investigation in addition to those prescribed in §§ 10927, 10928, and 10929.

D.C. Mun. Regs. tit. 22, r. 22-B10908

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.