PREV 602 MANAGEMENT OF CLINICAL TRIALS
This course emphasizes the practical application of organizing, managing, and conducting clinical trials. An overview of clinical trials theory and design characteristics provides the background necessary to conduct single center and multicenter studies. Topics encompass essential management functions and responsibilities by primarily focusing on the role of the research coordinator in enrollment, randomization, follow-up visits, timely reporting of adverse drug reactions and events, and study close-out. The role and function of specialized committee structures in multicenter trials are demonstrated. There are presentations and discussions on applied methodology using examples from several recent and ongoing clinical studies.