ICH E6(R3): 10 FAQ On What Changed And What It Means For Your Trials

With the finalization of the ICH E6(R3) guideline, the world of clinical research is undergoing a significant transformation. This industry change represents a fundamental shift from a rigid, checklist-based mentality to a flexible, risk-proportionate framework. The new guidance is designed to modernize every aspect of a trial, from protocol design and data governance to the use of decentralized technologies and patient consent. It emphasizes building quality from the start, ensuring that trial processes are proportionate to the risks involved, and prioritizing participant safety above all else.

Ultimately, ICH E6(R3) aims to make clinical trials more efficient, adaptable, and patient-centric, while upholding the highest standards of scientific and ethical integrity. Read on to discover the 10 most critical changes and what they mean for the future of clinical research.