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Course Catalog

340.645.01 INTRODUCTION TO CLINICAL TRIALS

Department: Epidemiology
Term: 2nd term
Credits: (3 credits)
Contact: Janet Holbrook
Academic Year: 2012 - 2013
Course Instructors:
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.
Student Evaluation: assignments and final exam
Learning Objective:

Present the scientific rationale for conducting clinical trials • Acquaint students with various clinical trial designs • Provide an understanding of randomization and of the principle of analysis by assigned treatment • Familiarize students with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials • Illustrate topics with examples of clinical trials
Location: Baltimore
Class Times:
  • Monday 1:30 - 2:20
  • Wednesday 1:30 - 2:20
  • Friday 1:30 - 2:20
Enrollment Minimum: 15
Enrollment Maximum: 75
Instructor Consent: Consent required for all students

If auditing if prerequisite not met
For consent, contact: jholbroo@jhsph.edu
Prerequisite:

340.601 or 340.751
Auditors Allowed: Yes, with instructor consent
Grading Restriction: Letter Grade or Pass/Fail
Catalog Subcommittee Actions: Required, RequiredNote, FrequencySchedule, CourseLocation, AuditorsAllowedId, CourseOfferRationaleNote, ClassroomNeeds, ClassroomNeedsNote, ContactPerson2, ContactEmail2, StartingOfferYear, RepeatableRetakable, ScheduleTypeId, LabScheduleTypeId, CPInstructor, .11/11/2011;