Required FSM Good Clinical Practice (GCP) Training

Northwestern University and the Feinberg School of Medicine

Good Clinical Practice (GCP) is an international, ethical, and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Northwestern University and the Feinberg School of Medicine will require, as of January 1, 2017, GCP training for all investigators, co-investigators and study personnel listed on the Northwestern University IRB application and involved in research defined as follows by the NIH clinical trial definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

All investigators, Co-Investigators and study personnel have until January 1, 2017 to come into compliance with this policy.

Accepted training to meet the GCP training requirement will include one of the following:

  • ACRP Good Clinical Practice: An Introduction to ICH GCP Guidelines through the MyHR Learn system
    • Navigate to MyHR Learn
    • Type "GCP" in the search bar in the upper right hand corner
    • Select the course title listed above
  • ACRP GCP for the Experienced CRC (recommended as a refresher course)
    • Navigate to MyHR Learn
    • Type "GCP" in the search bar in the upper right hand corner
    • Select the course title listed above
  • ACRP GCP for the Experienced Investigator (recommended as a refresher course)
    • Navigate to MyHR Learn
    • Type "GCP" in the search bar in the upper right hand corner
    • Select the course title listed above
  • NUCATS Institute CRC Basic Training Course
  • CITI Good Clinical Practice (GCP) Course
    • Access course information
    • Please note that the CITI Human Subjects Protections course does not fulfill the GCP Training requirement
  • NIH Clinical Research Training online from the Office of Clinical Research Training and Medical Education
  • NIH Good Clinical Practice for Social and Behavioral Research
  • Industry sponsored GCP Training approved by TransCelerate

Investigators, co-investigators and study personnel who have taken an accepted training program on or after January 1, 2014 do not need to participate in initial training, but should notify of the previously received training by sending in a copy of your certificate through REDCap in order to verify prior training. You should also select a Northwestern University approved recertification option and complete it within 3 years of your most recent training. If training is completed through the NIH or another external institution, you must follow the same notification process to the IRB office.

New investigators, co-investigators and study personnel (or those who have not had any GCP training since January 1, 2014) will be required to participate in one of the accepted training options by January 1, 2017.

GCP Training Facts

  1. What is Good Clinical Practice?
    Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. While human subjects protections training requirements are one part of GCP, those training requirements do not meet the full spectrum of competencies GCP training requires.
  2. Who does this new training requirement apply to?
    Investigators, co-investigators and study personnel listed on the IRB application involved in research defined as follows by the NIH clinical trial definition:
    A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
  3. How often do I need to be trained?
    You need to participate in an initial training and then be recertified every 3 years. Individuals trained from January 1, 2014 through January 1, 2016 do not need to participate in initial training but when their current training expires they should re-certify using one of the Northwestern University approved options.
    Initial Training Date Date for Initial Certification or Recertification Training
    Available

    Prior to January 1, 2014
    or
    First Time Training

    January 1, 2017

    Accepted Training

    • ACRP Good Clinical Practice: An Introduction to ICH GCP Guidelines (extended 5-hour course)
    • NUCATS CRC Basic Training Course
    • CITI Good Clinical Practice (GCP) Course
    • NIH Clinical Research Training online from the Office of Clinical Research Training and Medical Education
    • NIH Good Clinical Practice for Social and Behavioral Research
    • Industry sponsored GCP Training approved by TransCelerate (please submit certificate to REDCap to be added to your training profile)

    January 1, 2014 and ongoing

    Recertify every 3 years beginning on January 1, 2017.

    Accepted Training

    • ACRP Good Clinical Practice: An Introduction to ICH GCP Guidelines (extended 5-hour course)
    • ACRP GCP for the Experienced CRC
    • ACRP GCP for the Experienced Investigator
    • NUCATS CRC Basic Training Course
    • CITI Good Clinical Practice (GCP) Course
    • NIH Clinical Research Training online from the Office of Clinical Research Training and Medical Education
    • NIH Good Clinical Practice for Social and Behavioral Research
    • Industry sponsored GCP Training approved by TransCelerate (please submit certificate to REDCap to be added to your training profile)
  4. Does your Northwestern NetID/password link with your existing CITI account?

    If not, then read these instructions for registering or linking your existing CITI account.

  5. If I would like to take one of the ACRP Good Clinical Practice (GCP) courses through MyHR Learn, what information do I need to login?

    Log In using your Northwestern University issued NetID and password.

    If you are unable to login with you NetID or cannot access the GCP course, you must submit an email to consultant@northwestern.edu .

    If you are not a current Northwestern University Employee or Student, a POI ID may be required in order to access and complete training in the MyHR Learn system. In these cases, a form will be provided for you to complete to request a POI. Please note that persons other than active University faculty, staff, or students must have a University sponsor to assist them in gaining the affiliate credentials needed to access MyHR Learn.

  6. Who should I contact if I have additional questions?

    If you would like to speak with someone regarding any additional questions, please email gcptraining@northwestern.edu.