TOPICS IN MANAGEMENT OF CLINICAL TRIALS Syllabus

340.671.11 | AY 2013-2014 - Summer Inst. Term | 2 Credit(s)
MTWThF 8:30:00 AM
  • Contact Information
    Faculty
    Aynur Unalp-Arida
    Roberta Scherer
    TA
    Erin Corless
  • Course Learning Objectives

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

    • Apply competencies gathered throughout this and other epidemiology or biostatistics courses on key components of multicenter clinical trials
    • Develop strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures
    • Enhance skills to conduct multicenter trials
  • Course 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 Good Clinical Practice, organizational models, applicable Institutional Review Board and the U.S. Food and Drug Administration regulations, methods for randomization and treatment allocation, adverse event reporting, safety and performance monitoring. Encourages discussion of methods, including alternatives to usual practice.
  • Intended Audience
    JHSPH students and Summer Institute participants
  • Methods of Assessment

    3 exercises

  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

  • Academic Ethics Code

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Disability Support Services
    If you are a student with a documented disability who requires an academic accommodation, please contact the Office of Student Life Services at 410-955-3034 or via email at dss@jhsph.edu.