The Research Product Review Committee (RPRC) reviews study team management of medical devices, wearables (watches, step monitors, sleep monitors, etc.) as well as select DEA regulated drug studies to ensure proper management of the products utilized in the study.
This includes, but is not limited to: any instrument, machine, contrivance, implant, in vitro reagent that is intended to treat, cure, prevent, mitigate, diagnose disease in humans; including mobile medical apps as well as approved/on label use of medical devices. Also included are devices that are used as part of a behavior modification and/or physiology study.
An Investigational Product Management Plan (IPMP) will be required of the study team.