Major Revisions to the Clinical Trials Registration and Reporting Policy

Overview

Effective January 9, 2026, the Clinical Trials Registration & Reporting Policy has been revised to align with evolving best practices for clinical trial transparency and stricter enforcement of federal requirements (e.g., FDA Amendments Act (FDAAA) and the NIH policy), enabling UCSF to demonstrate its commitment to upholding public trust and adhering to ethical research practices.

The revised policy contains several updates, including structural changes, revised definitions, clarified roles and responsibilities for principal investigators, sponsors, and other parties, burden-reducing provisions, and defined consequences for noncompliance.