Key changes include: 

1. Revised and expanded definitions to enhance clarity and ensure consistency across the policy
2. Policy Enhancements

• Clarified Applicability Requirements: Specified conditions for clinical trial registration and results reporting, including NIH and CMS registration mandates.
• Secondary ID Requirement: Added to ensure compliance with NIH monitoring requirements.
• Record Maintenance: Required regular updates to ClinicalTrials.gov records to maintain accuracy and adherence to regulatory guidelines.
• Results Reporting Requirements: Expanded details on submission timeframes for FDA and NIH trials and added requirements for uploading supporting documents such as protocols, statistical analysis plans, and consent forms.
• Data Sharing Statement: Mandated adherence to ICMJE publication standards through the inclusion of a data sharing statement. 

3. Federal Compliance and Enforcement Updates 

• Expanded Federal Requirements: Incorporated NIH and CMS registration and results submission mandates alongside FDA guidelines.
• Enforcement Mechanisms and Penalties: Detailed NIH and FDA enforcement processes, including civil monetary penalties, notices of noncompliance, denial of Medicare claims, funding suspension, and publication restrictions. 

4. Consequences of Noncompliance 

Escalation Pathways: Added UCSF-specific approaches for addressing noncompliance, including department leadership involvement and potential disciplinary actions. 

5. Revised Summary of Responsibilities 

If you have questions or comments about this proposed policy, please respond via this feedback form by November 10, 2025.