Skip Navigation

Course Catalog

340.613.11 DESIGN AND CONDUCT OF CLINICAL TRIALS

Cancelled

Department: Epidemiology
Term: Summer Inst. term
Credits: 3 credits
Contact: Ayesha Khan
Academic Year: 2012 - 2013
Course Instructor:
Description:

Introduces issues in the design, organization, and operation of randomized controlled clinical trials, emphasizing long-term multicenter trials. Topics include ethical issues in trial design; concepts of controls, masking, and randomization; data collection; ongoing monitoring for evidence of adverse or beneficial treatment effects; organizational structure and data analysis principles.

Learning Objective(s):

Students will become familiar with the design, organization and operating procedures for clinical trials; Define the concepts and principles underlying trials; Be able to distinguish good and bad design by examples; Have a working knowldege of key scientific, political, and practical issues in the design and analysis of trials; Develop a detailed understanding of concepts of randomization and masking.


Methods of Assessment: Student evaluation is based upon laboratories, assignments, and an examination.
Location: East Baltimore
Class Times:
  • Monday 1:00 - 5:00
  • Tuesday 1:00 - 5:00
  • Wednesday 1:00 - 5:00
  • Thursday 1:00 - 5:00
  • Friday 1:00 - 5:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

340.601

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