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.

GCP Renovation (ICH E8(R1) and ICH E6(R3))

Dec 6, 2023, 20:58 PM

Title : GCP Renovation (ICH E8(R1) and ICH E6(R3))

Course ID : 298

Acronym : CTCICH

Course Description

In January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8(R1) in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, ICH GCP (ICH E6(R3)) includes a complete rewrite of existing the guideline, triggering a paradigm shift in how companies approach these changes. While the majority of these changes are anticipated to be embraced by the industry as a means to modernize the regulatory landscape, some formidable challenges will need to be addressed. In this web seminar, we will delve into the subject matter in alignment with the intentions of the International Council for Harmonisation (ICH). We will explore how ICH E6 and E8 complement each other and discuss their implications for the industry’s evolving regulatory environment.

Learning Objectives

Describe the regulatory background that has led to the changes
Explain the changes within ICH E8(R1)
Explain the changes within ICH E6(R3)
Describe the concept of Quality by Design and its application to clinical development
Understand the role of risk management and measured quality in Quality by Design

Who Should Attend

Clinical Research Associates/Monitors
Clinical Trial Leads
Data Managers/Data Scientists
Statisticians
Regulatory Affairs Professionals
Pharmacovigilance Professionals
Executive Management

Instructor

Andy Lawton

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#: 0778-0000-25-036-L99-P. Released: 2/25.

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

Series :