GCP Training

Investigators, Sponsors and IRBs must have a working knowledge of Good Clinical Practice (GCP) in order to assure the best protection of human subjects involved in research.

Copernicus Group IRB (CGIRB) looks to each group to be knowledgeable of GCP and adhere to GCP guidelines during the conduct of clinical trials. GCP training information may be obtained from one or more of the following sources:

  • Collaborative IRB Training Initiative (CITI)
    CITI is a web based training program with modules for Biomedical and Social & Behavioral Research. It is optional and available free of charge to non-institutionally affiliated Investigative Sites with protocols under CGIRB’s approval. To register for the CITI course under CGIRB:

    • Go to https://www.citiprogram.org.
    • In the top right corner of your screen, click “Register.” Upon clicking “Register,” a new page will appear.
    • In the section, “Select Your Organization Affiliation,” type into the search box “Copernicus Group IRB.”
    • Check the box, “I AGREE to the Terms of Service for accessing CITI Program materials.”
    • Click the “Continue to Step 2″ button.
    • Continue filling out the seven steps of the CITI Learner Registration until complete.

    The entire course takes approximately 6 hours. The CITI system allows you to take the training over several sessions. In order to pass and receive a certificate of training, you must have an overall score of at least 80%. Once you have passed, CGIRB will receive a copy of your training certificate from CITI. If you have questions about CGIRB’s requirements, please contact Sydney Douglas, Corporate Trainer for the CITI program. Technical issues should be addressed to citiisupport@med.miami.edu. [If interested, CITI also provides CME credits. To learn more, click here.]

  • Responsible Conduct of Research (DHHS)
    This Responsible Conduct of Research (RCR) educational program is offered by the Office of Research Integrity. The Office of Research Integrity (ORI) is part of the US Department of Health and Human Services.
  • Human Participant Protections: Education for Research Teams (NIH)
    The National Institutes of Health (NIH) offers an educational program entitled “Human Participant Protections Education for Research Teams”. This tutorial presents common concepts, principles, and issues related to protection of human participants, including principles of bioethics and basic legal standards. The course includes narrative text, case studies, and exercises to provide research teams with a multifaceted approach to human subjects protection.
  • Pharmaceutical Education & Research Institute (PERI)
    PERI is a not-for-profit organization that offers training for the pharmaceutical industry. Several types of courses are offered with levels from beginner to advanced. PERI also designates the target audience (e.g.: Investigators, Study Coordinators, and Sponsor representatives).
  • Barnett International
    Barnett International is a division of Parexel. Barnett offers conferences, seminars, and also provides publications.
  • Association of Clinical Research Professionals
    ACRP is a professional organization for the clinical research industry that offers educational conferences and seminars on an international level. The mission statement of ACRP is “The purpose of the Association is to provide global leadership for the clinical research profession by promoting and advancing the highest ethical standards and practices.”
  • Drug Information Association
    DIA is a professional organization for the pharmaceutical industry that offers educational conferences and seminars on an international level. The Vision of DIA is “DIA will develop and deliver, on a global scale, ‘best in class’ educational programs, training courses and curricula in selected professional interest areas to support career development within highly regulated health care and related industries.”