CLINICAL TRIALS MANAGEMENT Syllabus

340.648.01 | AY 2013-2014 - 4th Term | 3 Credit(s)
TTh 2:00:00 PM
  • Contact Information
    Faculty
    Roberta Scherer
    Aynur Unalp-Arida
  • 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
    • describe developing strategies applicable at most participating centers in a Multicenter setting including writing study policies and procedures
    • 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 practical applications such as organizational models, use of standardization, and performance monitoring. Discussion of methods is encouraged, including alternatives to usual practice.
  • Intended Audience
    Masters and doctoral candidates and other individuals involved in or expected to be responsible for running clinical trials.
  • Methods of Assessment
    Project, homework assignments, class discussion & participation
  • Prerequisites
    Students may take either 340.601 or 340.751, but they must also take 340.645.

    Additional Faculty Notes:
    Some concepts covered in this course are also covered in 340.660.01, which is offered first quarter. 

  • Required Text(s)

    Additional Faculty Notes:

    We strongly suggest purchasing the following book. It describes the regulatory processes well and has a number of useful templates. It should be available in the bookstore.

    Liu MB and Davis K. 2010. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. 2nd Edition

     

     

  • 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.

  • Welcome Message

    Welcome to Clinical Trials Management.  In this class you will learn about how to conduct a clinical trial.  Class will meet from 2:00 pm to 3:20 pm on Tuesday and Thursdays. the room will be announced later.

  • Contact Information(from old syllabus)

    Tsung Yu- TA
    Email: tsyu@jhsph.edu

  • 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.