2.0

credits

Average Course Rating

Provides an overview of methods related to the day-to-day conduct of multicenter randomized clinical trials with an emphasis on the Coordinating Center perspective. Using case studies of multicenter clinical trials for illustration, emphasizes topics related to Good Clinical Practice, organizational models, applicable Institutional Review Board and the U.S. Food and Drug Administration regulations, methods for randomization and treatment allocation, adverse event reporting, safety and performance monitoring. Encourages discussion of methods, including alternatives to usual practice.