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Pharmaceuticals, Medical Devices

Overview of the Clinical Research Process

About the Course

Clinical research is the testing of experimental drugs, biologics, and medical devices in humans. This research is based on extensive preclinical work and, in most cases, without authorization by national regulatory authorities (e.g., the US Food and Drug Administration (FDA). Only a small percentage of products that begin human testing are actually approved for marketing after the sponsor of the research demonstrates that the compound or device is adequately safe and effective for general use. All clinical research is governed by Good Clinical Practice (GCP)—ethical and scientific standards that are designed to protect both the rights and welfare of research participants and the integrity of the data produced by clinical trials. These standards are found in laws, regulations, guidelines and directives. GCP applies across the entire development process beginning with the planning and design of research, and continuing throughout the conduct, analysis and reporting of research results. This online course is intended to provide a basic overview of the clinical research process for those who are involved in any aspect of the development, research, marketing or sales of new drugs, biologics and devices. Participants receive training in GCP compliance.