Adaption: 21 CFR Part 50, End-to-End Physical AI Oncology Clinical Trial Unification

This adaption extends the original 21 CFR Part 50 – Protection of Human Subjects to address the end-to-end integration of Physical AI systems, advanced robotics, digital twins, and AI/ML agents into oncology clinical trials. The ECFR version accessed online established foundational protections for human subjects in clinical investigations regulated by the Food and Drug Administration. The original 21 CFR Part 50 document is in the public domain and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license. This current work is not endorsed or sponsored by CFR.