ICH GCP E6 (R3) Update Training

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Author: MHC Research Integrity Department

Background

On January 6, 2025, the International Council for Harmonisation (ICH) released the final version of ICH GCP E6(R3), updating the 2016 E6(R2) standard. The revised guideline reflects modern approaches to clinical research, including decentralized trials, electronic systems, and risk-based oversight. This revision introduces significant changes affecting the responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs). The U.S. Food and Drug Administration (FDA) officially published the guideline on September 9, 2025, signaling its availability for U.S. investigators and sponsors.

MHC HRPP’s Approach

MHC HRPP will integrate these updates into our existing training process without requiring additional or early training for staff. While the McLaren IRB encourages all research personnel to complete ICH GCP training, formal certification is required only when specified by the sponsor or the individual study protocol.

  • Training Requirements: unless mandated by the study sponsor or NIH, researchers are not required to retake GCP training early solely due to ICH E6(R3).
  • Renewal Cycle: GCP training remains on a three-year renewal cycle.
  • Updated Content: Beginning with upcoming renewals, all GCP training through the CITI Program will reflect the ICH E6(R3) updates.

Optional Early Access:

Option A: Updated CITI GCP Modules

As of July 23, 2025, the CITI Program has updated all relevant GCP and related content to reflect the ICH E6(R3) Guideline for Good Clinical Practice. These updates have been automatically applied to affected modules except the GCP FDA Basic and Refresher courses which will be updated on October 15, 2025, to align with the new ICH E6(R3) Guideline

for Good Clinical Practice. The updated courses reflecting E6(R3) will also meet the minimum criteria for mutual recognition established by TransCelerate Biopharma.

  • New learners enrolling in GCP courses will receive the updated content.
  • Returning learners may re-complete previously completed modules at any time to access the revised material. Instructions are available directly through the CITI Program. GCP ICH E6(R3) Announcement Summary

Option B: New Standalone Course – “ICH GCP E6(R3): An Introduction”

McLaren Health Care has added a new course to its CITI Program library titled: “ICH GCP E6(R3): An Introduction” This course provides an overview of the updated guideline and highlights key changes from E6(R2).

To register:

  1. Log into your CITI Program account and click View Courses under Institutional Courses.
  2. Scroll to the bottom of the page and locate the box labeled Learner Tools for McLaren Health Care Corporation.
  3. Click the hyperlink titled Add a Course.
  4. On the enrollment questionnaire, scroll to Question 5 and select: ICH GCP E6(R3): An Introduction
  5. Scroll down and click Submit.
  6. Return to your course dashboard, scroll to the newly added course, and click Start Now to begin.

If you have any questions, please contact the IRB Office at 248-484-4950.

Best regards,

Research Integrity Department

McLaren Health Care

Resources

For those who would like to explore the ICH E6(R3) updates:

ACRP Comparison Table – outlines key changes between ICH E6(R2) and E6(R3)

Guidelines and Regulations Resource Center - ACRP – the Association of Clinical Research Professionals (ACRP) have prepared webinars, guidance documents, articles and other handouts to clarify the changes.

CITI - Collaborative Institutional Training Initiative – updated GCP training modules reflecting E6(R3) are now available.

FAQ’s

What is ICH GCP E6(R3)? It’s the revised international guideline for Good Clinical Practice, released in January 2025. It modernizes standards for clinical trials, including decentralized models, digital tools, and risk-based oversight.

Has the FDA adopted E6(R3)? Yes. The FDA published the final guidance on September 9, 2025, making it officially available in the U.S.

Do I need to retake GCP training now? No. You are not required to retake GCP training early unless your sponsor specifically requests it.

When will I see the updated content? All CITI Program GCP modules now reflect E6(R3). You’ll see the updates automatically during your next scheduled renewal.

Can I access the new material early? Yes. You may voluntarily re-enroll in the updated CITI modules or take the new standalone course: “ICH GCP E6(R3): An Introduction”

Who can I contact with questions? Please reach out to the IRB Office at 248-484-4950 or email the Research Integrity Department at [email protected]