340.645.81 INTRODUCTION TO CLINICAL TRIALS
- 3rd term
- 3 credits
- Academic Year:
- 2012 - 2013
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.
- 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:
Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses.