CCTR 520. Fundamentals of Research Regulation. 2 Hours.

Semester course; 2 lecture hours. 2 credits. Focuses on the regulations that govern translational and clinical research. There will also be a series of discussions on the influence of international policies and research guidelines on the conduct of research. Topics include, but are not limited to, the history and current role of the FDA and the OHRP within the research arena; informed consent regulations relevant to federally funded research i.e., the common rule; informed consent regulations relevant to investigations conducted in support of a new drug application or an expanded marketing indication; good clinical practice guidelines; international conference on harmonization (ICH) conduction of research guidelines; HIPPA rules and regulations relevant to the conduction of research on human subjects; fiscal accountability/responsibility; and clinical trial registration and results reporting guidelines.