340.648.01 CLINICAL TRIALS MANAGEMENT

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 practical applications such as organizational models, use of standardization, and performance monitoring. Discussion of methods is encouraged, including alternatives to usual practice.

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.