Background On January 6, 2025, the International Council for Harmonisation (ICH) released the final version of ICH GCP E6(R3), updating the 2016 E6(R2) standard. The revised guideline reflects modern approaches to clinical research, including decentralized trials, electronic systems, and risk-based oversight. This revision introduces significant changes affecting the responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs). The U.S. Food and Drug Administration (FDA) officiall...