Guideline for Good Clinical Practice ICH E6 (R3)
The ICH E6 (R3) Guideline reached Step 4 of the ICH process on 06-Jan-2025.
This marks a major milestone in the evolution of clinical trials, emphasizing risk management and quality by design across all stages of a study.
The E6 (R3) introduces a proportionate, risk-based approach, allowing trial activities to align with the complexity and specific objectives of each study. This not only enhances efficiency but also strengthens the protection of participants and data integrity (key pillars of ethical research).
What is more, the updated guideline integrate technological and methodological innovations, ensuring they remain relevant in a rapidly advancing landscape of clinical research.
The global implementation will vary by region, but it is critical for all clinical research professionals to become familiar with these changes and adapt their practices to meet the new standards.
