Clinical Trials & Post-market Surveillance.

Catalog description

Students explore the design, management, and regulatory requirements of clinical trials to ensure the safety and efficacy of new medical products. Topics may include clinical trial phases from preclinical studies through Phase I, II, III, and post-market Phase IV evaluations. Students apply principles of trial design such as randomization, blinding, sample size determination, and ethical protections including informed consent and patient safeguarding. Students assess post-market surveillance systems that monitor continued product safety and effectiveness, including adverse event reporting, risk management, and FDA oversight of product recalls. Prerequisite: ABMS 5301 , ABMS 5302 , ABMS 5303 & ABMS 5304 .