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

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.