Fund of Clinical Trials II

(3 Credits)

The second course in the Clinical Trials sequence, Fundamentals of Clinical Trials II is a more advanced treatment to the design, conduct, and analysis of clinical trials. Topics include the FDA and US regulatory authorities, pharmaceutical research and industry, drug development and discovery, toxicology testing, pre-clinical requirements for human testing, safety reporting in clinical trials, phases of clinical trial development and design, IRB and ethics committees, trial monitoring, and multi-center trials.