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Course Catalog

340.645.81 Introduction to Clinical Trials


3rd term
3 credits
Academic Year:
2014 - 2015
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Janet Holbrook
Course Instructors:

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses. Acceptance into the FDA COHORT


Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase I-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; data analysis principles; monitoring of accumulating safety and efficacy data; and use of data from randomized trials.

Learning Objectives:

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

  1. Present the scientific rationale for conducting clinical trials
  2. Assess various clinical trial designs
  3. Discuss randomization and the principle of analysis by assigned treatment
  4. Discuss ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
  5. Illustrate topics with examples of clinical trials
Methods of Assessment:

assignments and final exam

Enrollment Restriction:

Restricted to FDA Fellows in approved program

Instructor Consent:

Consent required for all students

Consent Note:

Consent of instructor is required.

For consent, contact:

Special Comments:

The third term course is restricted to and offered only to students preselected into a special program limited to Food and Drug Administration employees. No one else is permitted to take this section of this course. There are no exceptions granted.