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Clinical Trials Management

East Baltimore
4th term
3 credits
Academic Year:
2021 - 2022
Instruction Method:
Class Times:
  • Tu Th,  2:00 - 3:20pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor:
Ann Ervin

Students may take either 340.601 or 340.751, but they must also take 340.645. (n.b. Some concepts covered in this course are also covered in 340.660 offered 1st term.)


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 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. Describe developing strategies applicable at most participating centers in a multicenter setting including writing study policies and procedures
  3. Conduct multicenter trials
Methods of Assessment:

This course is evaluated as follows:

  • 50% Group Project(s)
  • 20% Homework
  • 15% Group Presentation
  • 15% Quizzes

Instructor Consent:

No consent required

Special Comments:

can substitute for 340.660 Practical Skills in Conducting Research for 2019-2020.