The end-to-end physical ai oncology clinical trial unification guidance is a replacement draft to the International Council for Harmonisation (ICH) E6(R3) Guideline for Good Clinical Practice (GCP). This new adaption incorporates scalable AI and robotics workflows into clinical trials. The original ICH E6(R3) document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license, as detailed in Legal Notice. This current work is not endorsed or sponsored by ICH.
Kevin Kawchak (2026) studied this question.