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Course Catalog

340.648.01 CLINICAL TRIALS MANAGEMENT

Department: Epidemiology
Term: 4th term
Credits: 3 credits
Contact: Bobbi Scherer
Academic Year: 2013 - 2014
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 practical applications such as organizational models, use of standardization, and performance monitoring. Discussion of methods is encouraged, 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
describe developing strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures
conduct multicenter trials

Methods of Assessment: Project, homework assignments, class discussion & participation
Location: East Baltimore
Class Times:
  • Tuesday 2:00 - 3:20
  • Thursday 2:00 - 3:20
Enrollment Minimum: 5
Enrollment Maximum: 35
Instructor Consent: No consent required
Prerequisite:

Students may take either 340.601 or 340.751, but they must also take 340.645.

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