ICH E6 (R2)

ICH E6 (R2) is a set of internationally accepted guidelines that ensure the quality, safety, and integrity of clinical trials involving human participants. It provides a framework for designing, conducting, recording, and reporting trials to protect participants and produce reliable results. The update emphasizes better planning, quality management, risk-based approaches, and improved collaboration among investigators, sponsors, and regulators. Overall, it helps ensure that clinical research is conducted responsibly, ethically, and consistently across different countries and institutions.