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FDA is proposing to revise the responsibilities of sponsors and investigators for the conduct of clinical investigations of human drug and biological products in 21 CFR Part 312 subpart D, and to make conforming changes. This rule would update the Agency's requirements for sponsors and investigators to reflect the modern clinical trial ecosystem with a focus on clinical trial quality.  This would improve FDA's ability to ensure the rights, safety, and welfare of trial participants and the reliability of results, while supporting innovation and efficiency in clinical trial conduct.  The proposed updates also would align FDA's requirements with those of our global regulatory counterparts, helping to ensure that sponsors are not incentivized to conduct clinical trials outside of the United States and that studies of drugs and biological products submitted for FDA review are representative of the U.S. population the products are intended to treat.