ABSTRACT
Good Clinical Practices (GCPs) were created to encompass a collection of regulations, guidelines, ethical principles, and industry standards that would ensure that data derived from human clinical trials could be used to support marketing applications made to regulatory agencies for drugs, biologics, or medical devices. Unlike Good Manufacturing Practices, the GMPs, which are codified in 21 CFR 211: Current Good Manufacturing Practice For Finished Pharmaceuticals, there is no single regulation entitled “Good Clinical Practice.” To follow GCPs is to comply with a myriad of regulations, guidelines, and ethical standards. To conduct a clinical trial in compliance with GCPs means that the research at hand protects the safety and wellbeing of human subjects and provides that quality scientific data is derived from the research.
