10908. INVESTIGATIONAL PLAN

10908 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; 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. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10908