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