Preparing for ICH GCP E6(R3) implementation

The long-awaited updated guidance for the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) marks a transformative shift in global clinical trials and regulatory affairs, including significant changes to both the structure and content. As we move into Step 4 of the ICH Procedure (adoption), sponsors and stakeholders must undertake a comprehensive analysis and comparison between E6(R2) and (R3) to assess and implement changes, update procedures, systems and working practices, as needed.

ICON’s Regulatory Affairs experts have conducted a comprehensive, line-by-line analysis of the ICH E6(R3) changes, identifying key impacts and developing strategic, cross-functional solutions. Our cross-functional team delivers insights on ICH GCP E6(R3) implementation, risk management and change management strategy in clinical trials to support sponsors in maintaining the integrity and credibility of clinical trial data.

Download the whitepaper to learn:

• The purpose and scope of the E6(R3) updates
• Key structural and content changes, including the top five most impacted areas
• Risk impact insights from ICON Regulatory Affairs’ in-depth analysis
• Change management strategies to guide your compliance journey

The guidance also reinforces ethical standards, aligning Good Clinical Practice principles and broader ethical guidelines for clinical research to ensure the highest clinical trial ethical standards and the safety and well-being of trial participants.