Navigating the Future of Clinical Trial Monitoring

Insights from ICH Draft Revision E6(R3), Risk-Based Approaches, and Quality Systems in GCP Compliance

Senior Vice President and Chief Quality Officer at Beaufort John R. Wilson Jr., Ph.D.
Authored by: John R. Wilson Jr., Ph.D.
Senior Vice President and Chief Quality Officer

The International Council on Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline was first finalized in 1996 and described the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, sponsors, and Institutional Review Boards (IRBs). Subsequent revisions encouraged the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, and recording and reporting, while continuing to ensure human subject protection and reliability of trial results.

On May 19, 2023, the ICH released draft revision E6(R3) with updated regulatory and quality standards for a more modernized and adaptive risk-based approach to planning, designing, conducting, recording, and reporting clinical trials. The major areas of focus in ICH E6(R3) Draft remain concise:

“Fostering a quality culture and proactively (versus retrospectively) designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.”

Beaufort is adept at advising sponsors in the application of GCP guiding principles throughout the clinical trial process

Beaufort is adept at advising sponsors in the application of GCP guiding principles throughout the clinical trial process. Our team has thoroughly reviewed E6(R3) and was asked to be a contributing author to the 2024/2025 edition of Barnett’s Good Clinical Practice: A Question and Answer Reference Guide.

Our team addressed over 70 questions related to Study Sponsors and Investigator Site Monitoring, and below are several key takeaways and important issues covered:

What are the key messages for Monitoring of Trials (Section 3.11.4) in ICH GCP E6(R3) Draft?

Should sponsors have their site monitors monitor against the FDA’s GCP regulations/guidelines or the ICH GCP guideline, or both?

What is Adaptive Monitoring?

Is there any guidance on how risk-based monitoring plans should be developed and what elements should be included?

How should sponsors determine monitoring frequency for clinical studies?

FDA compliance officials increasingly are speaking about the importance of sponsors’ quality systems in clinical research, and of the shifting expectations for sponsor’s clinical trial oversight, to a quality risk management approach in trial oversight. What do they mean by this?

What implications does the FDA’s “fitness for use” definition and approach to high-quality data have for clinical trial monitoring, acceptable error rates, source data verification, and related issues?

What kinds of alternate monitoring practices exist if a sponsor is not going to conduct 100% verification through extensive on-site visits?

How Beaufort can Help

As the clinical research landscape continues to evolve with ICH E6(R3) Draft, Beaufort stands as a trusted partner, bringing a wealth of GCP expertise to meet the latest industry standards. Our team is dedicated to guiding sponsors through the intricacies of risk-based monitoring, ensuring a proactive approach to quality in clinical trials. Beaufort’s provides a seamless integration of cutting-edge strategies, compliance assurance, and a commitment to unlocking the full potential of your research programs.

Contact us today to learn more.

Contact Us

View all news & insights