The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice (GCP) was adopted by regulatory members of the ICH Assembly on January 6, 2025. The final version of the updated guideline, which aims to foster a culture of quality as technologies and methods evolve, is now recommended for adoption by regulatory authorities in ICH regions, which include the U.S., Europe, and Japan.
“Although the latest guideline was adopted on January 6, stakeholders are not expected to implement all changes immediately,” notes Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University. “While the guideline offers a global standard, each country’s regulatory body can decide what to adopt based on its own needs.”
“A phased approach allows for impacts to be fully understood across the study lifecycle, and to enable stakeholders to do things ‘right the first time,’” says Fritter. “Impacts on existing processes, standard operating procedures, and policies should be evaluated, with stakeholders considering a more flexible, risk-based approach to position themselves for improved efficiency, quality, and compliance.”
“ICH E6(R3) builds on earlier guidelines, including ICH E6(R2) and ICH E8(R1), by further emphasizing quality factors, and reinforcing the importance of proactive quality management and risk-based approaches,” states Leslie Sam, BA, CSSBB, CQIA, President of Leslie Sam and Associates, LLC. “However, in some cases, we are still in the process of defining how this standard of quality should be demonstrated in practice.”
ICH E6(R3) reminds stakeholders of the need for maintaining quality oversight of work delegated to service providers such as contract research organizations, according to Sam. “Effective oversight requires critical thinking, as the most suitable approach will vary depending on the specific situation. There is no universal, ‘one-size-fits-all’ solution.”
Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice
Join Leslie and Jessica at ACRP 2025 [April 24-27; New Orleans, La.], for a discussion on the principles described within ICH E6(R3), the changes from ICH E6(R2), the implications for GCP, and more. View complete schedule.
The updated guideline also reframes the concept of risk, expanding its definition to encompass hazards and harms related to participant protection and data reliability. Fritter explains, “Protecting data as technology advances is a high priority, with a focus on data governance, accountability, validation, and transparency.”
“Looking ahead, the industry will need to continue to gain even more clarity and understanding on what constitutes ‘good’ quality, from both sponsor and service provider perspectives,” says Sam. “Successful implementation of these updates requires stakeholders to balance both strategic oversight and operational execution. If adopted effectively, ICH E6(R3) has the potential to advance clinical research by fostering adaptability in response to evolving science and technologies.”
Edited by Jill Dawson
