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Course Catalog

340.648.98 CLINICAL TRIALS MANAGEMENT

Department:
Epidemiology
Term:
2nd term
Credits:
3 credits
Academic Year:
2013 - 2014
Location:
Barcelona, Spain
Dates:
Thu 11/21/2013 - Sat 11/23/2013
Class Times:
  • Th F Sa,  8:30am - 6:00pm
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Judy Holzer
Course Instructor:
Frequency Schedule:
One Year Only

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Description:

Provides an overview of methods related to the day-to-day conduct of multicenter randomized clinical trials with an emphasis on the Coordinating Center perspective. Using case studies of multicenter clinical trials for illustration, emphasizes topics related to practical applications such as organizational models, use of standardization, and performance monitoring. Discussion of methods is encouraged, including alternatives to usual practice.

Learning Objectives:

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

  1. Apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials
  2. describe developing strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures
  3. conduct multicenter trials
Methods of Assessment:

Project, homework assignments, class discussion & participation

Instructor Consent:

Consent required for some students

Consent Note:

Full-time JHSPH students must obtain consent from Judy Holzer or Pam Davis is HPM prior to registering for this class.

For consent, contact:

jholzer@jhsph.edu