340.671.11 TOPICS IN MANAGEMENT OF CLINICAL TRIALS

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.

Upon successfully completing this course, students will be able to apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials; practice developing strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures; enhance skills to conduct multicenter trials.