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.
Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Course Description
The premise behind RBQM is that monitoring quality can be improved by leveraging existing data. The development of quality and risk management metrics involves identifying the values of an organization, and this web seminar will focus on developing measures to assess meeting those goals, building infrastructure to capture data to support the metrics, and establishing adequate and timely responses to drive improvement. As the industry’s utilization of risk-based monitoring continues to increase along with the development and expansion of RBQM, the need for integrating these two concepts is necessary.
Learning Objectives
- Describe the principles of QbD and new regulatory requirements for risk-based monitoring
- Provide an overview of GCP regulations and recent ICH GCP E6 and E8 revisions and their impact on QC/QA process and RBQM systems
- Develop relevant metrics as quality and performance indicators for RBQM systems and effective Corrective and Preventive Action (CAPA) Plans
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
- Identify and manage risks of clinical trials
- Perform cause-effect analysis for risks and develop mitigation strategies
Who Should Attend
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates
- Project Managers and Medical Monitors
- Regulatory Affairs Professionals
- Clinical Principal Investigators and Research Coordinators
- IRB Administrators and Members
Instructor
Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC
Click here for complete trainer biographies
Registration Fees
$735*
*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 1.5 hours (0.15 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#: 0778-0000-24-043-L99-P. Released: 9/24.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
- Clinical Trials & Translational Medicine
- Clinical Research
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Drug Safety
- Nursing
- Project Manager
- Study Site Compliance
- Training
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