Good Clinical Practice Training

Good Clinical Practice (GCP) is an international, ethical and scientific quality standard for the design, conduct, recording and reporting of 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 Feinberg School of Medicine require 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.:

To meet the GCP training requirement, you must complete one of the following:

If you are already trained by an outside resource and have a certificate of proof, please submit proof of training compliance to REDCap for review and tracking.

FAQ

How often do I need to be trained?

You need to participate in an initial training and then be recertified every three years. If you've already been trained, please submit proof of training compliance through REDCAP.

Does your Northwestern NetID/password link with your existing CITI account?

It should. If it doesn't, read these instructions for registering or linking your existing CITI account.

What does the ICH E6(R3) Guideline mean for Northwestern researchers?

On January 6, 2025, the International Council for Harmonisation (ICH) adopted the final version of the ICH E6(R3) Guideline for Good Clinical Practice (GCP). The updated guideline modernizes GCP expectations to reflect advances in clinical trial design, technology, and oversight while continuing to emphasize participant protection and data integrity.

GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants. Compliance with GCP helps ensure the rights, safety, and well-being of research participants and the credibility of clinical trial data. 

Northwestern University and the Feinberg School of Medicine requires Good Clinical Practice Training for investigators, co-investigators, and study personnel listed on a Northwestern IRB application who are involved in research that meets the NIH definition of a clinical trial. GCP Training is managed through the NUCATS Education Team.

·    GCP training completed under a previous version of the guideline (e.g., ICH E6(R2)) remains valid through the learner's current certification period.

·    There is no requirement to immediately retake GCP training solely because of the release of ICH E6(R3).

Additionally, per this CITI GCP ICH E6(R3) Announcement:

·    The updated ICH E6(R3) content has been incorporated into CITI Program GCP courses and will automatically be included in all new enrollments and renewals moving forward.

·    Individuals who would like to review the updated content before their current certification expires may voluntarily re-enroll in the updated CITI GCP modules.

Researchers should continue to follow institutional GCP training requirements and complete renewals as scheduled. Questions regarding GCP training requirements or course enrollment may be directed to NUCATS Education, nucats-ed@northwestern.edu.

Please note, the Northwestern University IRB Office does not oversee GCP requirements, and the completion of GCP training does not meet Human Research Protections Training requirements. Questions about human research protections (IRB) training may be directed to IRB Education, irbtraining@northwestern.edu.

If you have additional questions, please email nucats-ed@northwestern.edu.

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