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Topics in Managment of Clinical Trials

June 17 - June 21, 2019
1:30 pm - 5:00 pm
2 credits

Course Number: 340.671.11

Course Instructor:


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, ethical and the U.S. Food and Drug Administration regulations, methods for randomization, treatment allocation, blinding, and drug distribution, safety and performance monitoring, adverse event reporting, and trial policies. Encourages discussion of current methods.

Student Evaluation: Practice exercises; refinement of an existing protocol and informed consent statement

Learning Objective:

Upon successfully completing this course, students will be able to:

  1. Apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials
  2. Develop strategies applicable at most participating centers in a multicenter setting including writing study policies and procedures
  3. Enhance skills to conduct randomized controlled trials

Prerequisite: 340.601 or 340.751

Grading Options: Letter Grade or Pass/Fail