ICH E6(R3) Guideline for Good Clinical Practice
Training Resources Available from Barnett

With the release of ICH E6(R3) (Annex 1), it is more important than ever for you and your clinical trial teams to implement an R3 training plan to ensure that all stakeholders are up to speed on the new requirements outlined in the ICH E6(R3) Guideline for Good Clinical Practice.

Barnett is here to assist with your clinical research compliance training needs during this transition, offering a variety of resources to ensure you're fully prepared, including:

Live, instructor-led training
Self-paced eLearning courses
ICH E6(R3)-focused publications

Course Customization

All of Barnett's ICH E6(R3) training can be customized for teams, and delivered virtually or in-person. For more details contact Barnett today!

Subject Matter Experts Leading ICH GCP E6(R3) Training

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Andy Lawton

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Shelia Russell McCullers, M.S., D.M.

Denise G. Redkar-Brown, MT

ICH E6(R3) FAQs

Is ICH E6(R3) implemented?
ICH E6(R3) final principles and Annex 1 were adopted in January 2025. Annex 2 is currently in draft form and currently open for public consultation.

What is new with ICH E6(R3) change?
The International Council for Harmonisation (ICH) has released the E6(R3) guidelines for Good Clinical Practice (GCP), introducing new terminology, revised principles and roles and responsibilities requirements, documentation and records guidance, and a new focus on data governance, all while maintaining a strong focus on participant safety and data integrity.

What are the key differences between ICH E6(R2) and ICH E6(R3)?
The key differences between ICH E6(R2) and ICH E6(R3) lie in the expanded focus on risk management, technology integration, and operational efficiency. While E6(R2) introduced a risk-based approach to clinical trials, emphasizing the identification, assessment, and mitigation of risks, E6(R3) takes this further by encouraging the use of advanced technologies. E6(R3) also places a stronger emphasis on patient-centered practices, flexible trial designs, and continuous quality management throughout the trial lifecycle. ICH E6(R3) also aligns more closely with global regulatory expectations and integrates new guidelines, aiming to streamline trial processes and improve collaboration among stakeholders.

Will ICH GCP(R3) impact my role within clinical research?
ICH GCP(E3) can impact you in several ways, depending on the specific role you have in clinical research. It’s important to understand the specific changes in the guidance and how they will affect the day-to-day execution of clinical trials and studies—along with how to integrate these changes into trial implementation.

How can Barnett International help me prepare for this transition?
Now is the time to implement your ICH GCP(R3) training plan. Barnett provides a wide range of resources that integrate the new guidance to help you navigate the ICH GCP(R3) transition:

An all-new GCP eLearning course that covers R3 content in detail, meeting the requirement for GCP training/refresher training.
Short courses covering key proposed changes, including the steps and processes clinical research organizations need to have in place.
Training on implementing RBQM and QbD programs that meet the expectations of R3.
An ICH E6(R3)-focused publication to clarify current interpretation and understanding of R3 requirements.
Customized ICH E6(R3) training for teams, delivered virtually or in-person.

ICH GCP E6(R3) Updates: Implementing Risk Management Approaches for Compliance

Oct 6, 2018, 18:23 PM

Title : ICH GCP E6(R3) Updates: Implementing Risk Management Approaches for Compliance

Course ID : 224

Acronym : CPL

Course Description

The ICH GCP E6(R3) updates introduce a refined, standardized approach to risk management that builds on previous revisions. A key shift in the updated guidelines is the emphasis on a comprehensive, risk-based approach to quality management, with a clear focus on critical process and data identification, risk evaluation, and mitigation strategies. While Risk-Based Quality Management (RBQM) is now standard practice, the R3 revision also ensures that risk assessment and mitigation plans are required across all clinical trials, regardless of RBQM adoption. This web seminar will explore these updated requirements, focusing on risk management principles, including risk identification, evaluation, control, and reporting. Practical strategies for implementing the updated guidelines, along with step-by-step methodologies for risk management, will be provided.

Learning Objectives

Define the three-way risk evaluation methodology introduced in the ICH GCP E6(R3) update
Distinguish between risk mitigation and risk acceptance, and understand their application in clinical trials
Describe the concept of “predefined tolerance limits” as part of risk-based management
Explain the role of centralized monitoring in risk management and quality assurance
Develop a best practice implementation process for risk management based on practical experience

Who Should Attend

Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
Study Managers/Project Managers, CRAs/Monitors (Centralized, On-site)
Business Process Owners

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Shelia Russell McCullers, M.S., D.M.

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-033-L99-P. Released: 4/25.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

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