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340.671.11
Topics in Management of Clinical Trials

Location
East Baltimore
Term
Summer Institute
Department
Epidemiology
Credit(s)
2
Academic Year
2014 - 2015
Instruction Method
TBD
Start Date
Monday, June 23, 2014
End Date
Friday, June 27, 2014
Class Time(s)
M, Tu, W, Th, F, 1:30 - 5:00pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Contact Name
Frequency Schedule
Every Year
Prerequisite

340.601 or 340.751

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 Objectives
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