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ICH E6(R3)

How to Prepare for ICH E6(R3) Guideline for Good Clinical Practice

 

Twenty years ago, the International Council for Harmonisation (ICH) drafted the Guideline for Good Clinical Practice (GCP), ICH E6, an international ethical and scientific quality standard for clinical trials. Since then, the complexity of clinical trials has increased significantly, and ICH E6 has been revised to reflect changes in emerging technology and evolving trial designs.

The latest revision, ICH E6(R3), published in January 2025, builds upon GCP by further emphasizing the importance of proactively fostering quality culture in clinical trials and drug development planning.

Learn more about fostering a culture of quality in this on-demand webinar:

The Three Pillars of Quality Management

Adoption Timeline

The European Medicines Agency (EMA) will adopt ICH E6(R3) effective July 23, 2025. Other regulators have yet to announce an official endorsement of these updated GCP guidelines, but the U.S. Food & Drug Administration (FDA) has published a draft guidance. Further regulatory adoption is expected soon, so it’s imperative that investigators prepare to transition from ICH E6(R2) to ICH E6(R3).

Implementation
Stay Compliant With ICH E6(R3) With Trial Interactive

Trial Interactive’s team of industry experts can guide you through the process and consult on advanced technology and services that address the evolving needs of your clinical trial. Our eClinical platform offers ICH E6(R3) compliance through:

  • Seamlessly connected solutions

  • Decide what data to migrate and when

  • Share your data—we handle the mapping and transfer

  • Review results with our team and go live with confidence

Learn More About Migration Services

What Your Team Should Know About Migrating to a New CTMS

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Webinars

Three Pillars Of Quality Management

Three Pillars Of Quality Management

Three Pillars Of Quality Management