ICH GCP E6(R3): What CRAs Need to Know

The International Council for Harmonisation (ICH) released a revision of its Good Clinical Practice guideline—E6(R3). This update introduces changes with a strong focus on quality by design, critical thinking, and risk-based approaches throughout the clinical trial lifecycle.

This webinar is designed specifically for Clinical Research Associates (CRAs) and will explore how the upcoming E6(R3) revision will impact the CRA role in practice. We’ll cover what’s new, what’s changing, and what this means for monitoring activities, sponsor oversight, and interactions with sites.

Topics will include:

• Reason for the revision
• Key concepts introduced in ICH E6(R3) and main changes
• CRA’s role in Clinical Trials
• How quality by design and risk-proportionate approaches affect CRA responsibilities
• Enhancing CRA contributions to data quality and participant safety
• Shifting from checklist-based monitoring to critical thinking and risk-focused oversight
• Supporting investigator sites in building and sustaining a quality culture
• Preparing for the change: what CRAs can do now

The presentation will be followed by a live Q&A session to discuss practical scenarios, clarify common questions, and share experiences from the field.