Bridging the Gap from ICH GCP E6 R2 to R3

ICH GCP E6(R3) ONLINE UPDATE COURSE

Understand the changes introduced by ICH Good Clinical Practice E6(R3) and what they mean for the design, conduct, management and oversight of clinical trials.

Created by experienced clinical research and compliance professionals, this online ICH GCP E6(R3) training course provides a practical comparison of E6(R2) and E6(R3), helping you identify what has changed and how the revised expectations affect your role.

The course is suitable for individual clinical research professionals and organisations that need to update teams previously trained in ICH GCP E6(R2).

Current Status

Not Enrolled

Price

£39.99

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KEY FEATURES OF OUR ONLINE ICH GCP E6(R3) TRAINING COURSE

  • 100% online and available on demand
  • Learn anywhere, at your own pace
  • Developed by experts with more than 35 years of clinical research experience
  • Focused on the transition from ICH GCP E6(R2) to E6(R3)
  • Interactive content, practical examples and knowledge checks
  • Certificate awarded upon successful completion
  • Available for individuals and corporate teams
  • Course content available in 32 languages

Course Content

Bridging the gap from ICH GCP E6 R2 to R3

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PRACTICAL ICH GCP E6(R3) TRAINING DEVELOPED BY CLINICAL EXPERTS

ICH E6(R3) is the latest revision of the internationally recognised Good Clinical Practice guideline for clinical trials involving human participants.

The ICH E6(R3) Principles and Annex 1 were adopted in January 2025, introducing a more flexible, proportionate and risk-based framework for the design and conduct of clinical trials. Annex 2 was subsequently adopted in June 2026, completing the revised guideline and providing additional considerations for decentralised elements, pragmatic elements and the use of real-world data.

Our online ICH GCP E6(R3) update training course explains how the new guideline differs from E6(R2) and, importantly, what those differences mean in practice.

You will explore changes relating to participant protection, quality by design, risk-based quality management, sponsor and investigator responsibilities, data governance, monitoring, essential records and the use of technology and modern clinical trial approaches.

Rather than simply listing the differences between R2 and R3, the course uses practical explanations, realistic examples and knowledge checks to help you understand how the revised principles should influence clinical trial activities, processes and decision-making.

Important: This is an update course for professionals who already have a foundation in ICH GCP E6(R2). It does not replace comprehensive or accredited Good Clinical Practice training where required by an employer, sponsor, institution or regulator.

The adoption dates above reflect the current consolidated ICH guideline published in 2026. Official ICH E6(R3) update

WHO SHOULD COMPLETE ICH GCP E6(R3) UPDATE TRAINING?

This course is designed for people who are already familiar with ICH GCP E6(R2) and need to understand the transition to E6(R3), including:

  • Clinical research professionals
  • Clinical Research Associates and monitors
  • Clinical Trial Managers
  • Clinical Research Coordinators
  • Principal investigators and study-site personnel
  • Clinical trial sponsors
  • CRO employees and consultants
  • Regulatory affairs professionals
  • Quality assurance and compliance teams
  • Clinical operations personnel
  • Clinical data management professionals
  • Medical and scientific affairs teams

The course is particularly suitable for professionals who completed their original Good Clinical Practice training under E6(R2) and now need focused, practical training on the changes introduced by E6(R3).

ICH GCP E6(R3) TRAINING FOR INDIVIDUALS AND CLINICAL RESEARCH TEAMS

INDIVIDUAL LEARNERS

Training for individuals

Individual professionals gain immediate online access and can complete the ICH GCP E6(R3) update training at a time, location and pace that suits you.

CORPORATE TEAMS

Corporate training

Our multiple licence options help you provide consistent training across your teams while improving training and simplifying course admin and oversight.

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WHAT WILL I LEARN FROM THIS BRIDGING THE GAP FROM ICH GCP R2 TO R3 TRAINING COURSE?

Explain the key differences between ICH GCP E6(R2) and E6(R3), including changes in terminology, structure and key principles.

Describe how the R3 emphasis on risk-based quality management, critical-to-quality factors and proportionate oversight affects clinical trial activities.

Apply the updated R3 expectations for monitoring, data governance, participant protection and documentation to clinical trial processes.

Identify how modern trial approaches, including decentralised and digital methods, are addressed within E6(R3) and how these changes may affect clinical research responsibilities.

FREQUENTLY ASKED QUESTIONS ABOUT THE ICH GCP E6(R2) TO E6(R3) UPDATE COURSE

WHO IS THIS ICH GCP E6(R3) UPDATE COURSE FOR?

This update course is designed for clinical research professionals who already understand ICH GCP E6(R2) and need focused training on the transition to E6(R3).

It is suitable for Clinical Research Associates, investigators, study coordinators, Clinical Trial Managers, sponsor and CRO personnel, regulatory professionals, quality teams, data management professionals and others whose previous GCP training was based on E6(R2).

WHAT IS THE DIFFERENCE BETWEEN THIS UPDATE COURSE AND THE FULL ICH GCP E6(R3) COURSE?

This course focuses specifically on what has changed between ICH GCP E6(R2) and E6(R3). It assumes that learners already understand the foundations of Good Clinical Practice and concentrates on the revised principles, terminology, responsibilities and expectations introduced by R3.

Our full ICH GCP E6(R3) course provides comprehensive Good Clinical Practice training and is more suitable for new clinical research professionals, learners without current GCP training or anyone requiring complete E6(R3) training rather than an update.

SHOULD I TAKE THE E6(R3) UPDATE COURSE OR THE FULL GCP COURSE?

Choose this update course if you have previously completed comprehensive ICH GCP E6(R2) training and need to understand how E6(R3) differs.

Choose the full ICH GCP E6(R3) course if:

  • You are new to clinical research
  • You have not previously completed comprehensive GCP training
  • Your previous training or certificate is no longer accepted
  • Your employer or sponsor requires complete E6(R3) training
  • You need a full explanation of Good Clinical Practice rather than an R2-to-R3 comparison

If you are uncertain which option meets your organisation’s requirements, contact us before purchasing.

WHAT CHANGES FROM ICH GCP E6(R2) TO E6(R3) DOES THE COURSE COVER?

The course explores significant changes introduced by E6(R3), including its revised structure and principles, quality by design, critical-to-quality factors, proportionate risk management, sponsor and investigator responsibilities, service-provider oversight, monitoring, data governance and essential records.

It also explains how E6(R3) reflects technological developments and modern clinical trial approaches, helping learners understand how the revised guideline may affect their everyday responsibilities and processes.

DOES THIS UPDATE COURSE REPLACE FULL OR ACCREDITED GCP TRAINING?

No. This is a focused update course designed to supplement existing ICH GCP E6(R2) knowledge. It does not replace comprehensive or accredited Good Clinical Practice training where this is required by an employer, sponsor, institution or regulatory authority.

Learners and organisations should confirm their specific training requirements before purchasing. Anyone requiring complete GCP training should take our full ICH GCP E6(R3) course.

If this course isn’t right for you, take a look at our other online clinical courses.