340.660.01 | AY 2013-2014 - 1st Term | 3 Credit(s)
TTh 10:30:00 AM
  • Contact Information
    Lisa Jacobson
    Carla Zelaya
  • Course Learning Objectives

    After completing this course, you should be able to:

    • identify the required components of a clinical research study
    • prepare an informed consent for a clinical research study
    • develop a recruitment strategy
    • develop data collection forms
    • develop quality assurance procedures
    • distinguish and identify reporting requirements for clinical studies
  • Course Description

    This course emphasizes the practical aspects of conducting and organizing a clinical research project.  The course focuses on developing skills to develop and manage a research protocol, monitor the data collection, manage the data, and disseminate results.  Lectures cover the basic components of a clinical research team, the components of good clinical research practice, the responsibilities, expertise and tasks that each research team member is expected to perform, and organizational, logistical and attitudinal issues that need to be addressed when creating an effective research group. Additionally, translational research and the kinds of issues that arise when multi-disciplinary teams are brought together are explored.

    Additional Faculty Notes:

    3 credits

    Meets Tuesdays and Thursdays 10:30-11:50 am in W2017 in the Wolfe Building

  • Intended Audience
    K-12 grant trainees, clinical research scholars,and doctoral students in Epidemiology

    Additional Faculty Notes:
    Other interested students

  • Methods of Assessment
    laboratory exercises, class participation

    Additional Faculty Notes:

     Class participation, midt-term take-home, and final take-home

  • Prerequisites
    340.752 Epidemiologic Methods II and 140.622 Statistical Methods in Public Health or 140.652 Methods in Biostatistics

    Additional Faculty Notes:


  • Required Text(s)

    Additional Faculty Notes:

    NO textbook is required for the course.

    The following textbooks will be placed on reserve for interested students in the Welch Library.

    1.Meinert C. Clinical Trials: Design, Conduct, and Analysis. Oxford University Press, USA. 1986.

    2.  Spilker B, Cramer JA. Patient Recruitment in Clinical Trials. Raven Press, NY, 1991.

    3.Kelsey JL, Whittemore AS, Evans AS, and Thompson WD. Methods in Observational Epidemiology. 2nd Ed. Oxford University Press, USA, 1996.

    4.Race & Research: Perspectives on Minority Participation in Health Studies. Beech BM & Goodman M (editors). American Public Health Association. 2004.

    5.Cook S. Clinical studies management: a practical guide to success. Boca Raton, FL. CRC Press LLC. 2004.

    6.Stone J. Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators and Investigators, Mountainside, MD Press, 2006.

    7.Gallin JI and Ognibene F. Principles and Practice of Clinical Research, 2nd edition. Academic Press, 2007.

  • 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 the course! If you have any questions, feel free to email Course Directors Lisa Jacobson (, Carla Zelaya ( or Michelle Silver (Student Course Coordinator) at

  • Course topics
    Ethical considerations in human subjects research Study organization, documentation, and costs Recruitment and retention of participants Data collection and management Quality assurance and quality control Issues in the conduct of clinical trials Reporting issues
  • Contact Information

    Joan Pettit, J.D., M.A., CIP
    Office: JHSPH IRB Office
    Tel: (410) 502-1999

    Sarah Poynton, PhD
    Tel: 410-502-5065

    Michelle Silver

    Lawrence Appel, MD, MPH

  • 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