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Course Catalog

340.671.11 TOPICS IN MANAGEMENT OF CLINICAL TRIALS

Department: Epidemiology
Term: Summer Inst. term
Credits: 2 credits
Contact: Ayesha Khan
Academic Year: 2014 - 2015
Course Instructors:
Description:

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.

Learning Objective(s):
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
Develop strategies applicable at most participating centers in a multicenter setting including writing study policies and procedures
Enhance skills to conduct randomized controlled trials

Methods of Assessment: One short paper
Location: East Baltimore
Class Times:
  • Mon 06/23/2014 - Fri 06/27/2014
  • Monday 1:30 - 5:00
  • Tuesday 1:30 - 5:00
  • Wednesday 1:30 - 5:00
  • Thursday 1:30 - 5:00
  • Friday 1:30 - 5:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

340.601 or 340.751

Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail