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Course Catalog

340.645.81 INTRODUCTION TO CLINICAL TRIALS

Cancelled

Department:
Epidemiology
Term:
3rd term
Credits:
3 credits
Academic Year:
2012 - 2013
Location:
Internet
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Janet Holbrook
Course Instructors:

Visit the CoursePlus site for this course

Description:

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:
jholbroo@jhsph.edu
Prerequisite:

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