M410- Clinical Research Study Management and Compliance (CRSMC)

One of the main goals of the Master’s in Clinical and Translational Cancer Research is to train researchers to apply their understanding of biomedical science and analytical and critical thinking skills to solve challenging clinical problems. However, these skills are not sufficient to conduct successful clinical cancer research. Clinical scientists must also possess thorough knowledge of the management, regulatory, and compliance practices necessary to implement clinical research projects. This course aims to fulfil these training needs by focusing on the practical aspects of executing clinical trials in a Good Clinical Practice (GCP) and Human Subject Research (HSR) regulatory compliant fashion. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; managing relationships with external academic and industry partners, and the roles and responsibilities of investigators, sponsors, monitors, and auditors. The course will also provide an overview of regulatory affairs in relation to three key areas of therapeutic development: drugs, biologics, and medical devices. Throughout the course, practical issues facing researchers as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed. Through expert advice and groups discussions, this course will enhance the foundational knowledge that students gain during the CITI online modules and allow them to provide these lessons to their own research.