ICH GCP (Good Clinical Practice) E6(R3) Implementation: What You Must Be Doing Now In-house Training

Course overview

The long-awaited ICH GCP E6(R3) guideline has now been released, and with implementation from July 2025, clinical research teams must move from awareness to action. This one-day course provides a clear, practical understanding of the new requirements and how they affect day-to-day clinical research activities.

The course covers all core elements of ICH GCP E6(R3), including the updated expectations for digital technologies, automated systems and algorithmic/AI-enabled tools used in clinical trials. Participants will gain practical clarity on how R3 applies to modern data systems, proportional risk-based approaches, documentation, and oversight obligations. Regulators will increasingly expect organisations to demonstrate alignment with the updated principles - meaning preparation is essential.

E6(R3) represents the most significant shift in GCP in more than a decade, bringing stronger emphasis on Critical-to-Quality (CtQ) factors, quality-by-design thinking, enhanced data integrity requirements, and clearer shared responsibilities across sponsors, investigators, and service providers.

Rather than focusing on theory alone, this course uses real-world examples and practical scenarios to show how R3 should influence trial design, conduct, monitoring, vendor management, and inspection readiness. Whether your organisation has already begun transitioning or is just starting to implement, this course provides the insight, structure, and direction needed for smooth and compliant implementation.

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Benefits of attending

• Understand the key changes in ICH GCP E6 (R3) and why they matter now that implementation is underway
• Learn what regulators will expect to see as evidence of transition and readiness
• Gain clarity on risk-based, proportional approaches and how to integrate them into daily trial practices
• Strengthen your understanding of revised sponsor, investigator, and service provider responsibilities
• Improve documentation and data governance processes to align with the new standard
• Reduce the likelihood of inspection findings by ensuring your processes reflect E6(R3)

Who should attend

This course is ideal for clinical research professionals who need to understand and apply the new E6(R3) requirements in their daily work, including:

• Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs)
• Clinical Trial Managers (CTMs) and Project Managers
• Quality Assurance professionals
• Regulatory Affairs and compliance specialists
• Investigators and study site staff
• Sponsors, CRO teams, and service providers involved in trial oversight
• Anyone responsible for ensuring alignment with ICH GCP E6 (R3)