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Good Clinical Practice (GCP) Certification and ICH E6(R3)

August 5, 2026

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.

What does this mean for Northwestern University researchers?

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.

Sincerely,

Northwestern University Clinical & Translational Sciences Institute (NUCATS) Education, nucats-ed@northwestern.edu

&

Northwestern University Institutional Review Board (IRB) Office, irb@northwestern.edu