Clinical Research Policies
Site Committee
- Site Committee Membership Policy (Updated 12/12/2022)
- Site Committee Review Policy (Updated 11/18/2016)
- Site Committee Selection Policy (Updated 8/30/2021)
Protocol Review and Monitoring Committee
- Protocol Review and Monitoring Committee Membership Policy (Updated 08/06/2021)
- Protocol Review and Monitoring Committee Review Policy (Updated 5/02/2019)
- Amendment Submission Policy (Updated 11/23/2020)
- Amendment Review Policy (Updated 10/27/2020)
- Protocol Closure Policy (Updated 12/04/2018)
Study Conduct
Guidelines
- PPM Guidance for Notification of Voluntary Enrollment Holds (v. 28 July 2015)
- Guidance for OnCore eCRF Approval Prior to the Start of Enrollment
- Guidance for Completion of Baseline Conditions
Policies
- Policy on Clinical Research Policies (17 Sept 2021)
- Clinical Research Policy Template and Style Guide (7 Dec 2021)
- DSMC Mandated Hold on Enrollment Policy (20 Jan 2022)
- Requirement for the Notification of the DSMC for SNC Reports (27 Oct 2021)
- Clinical Research Activation Policy for Industry Trials (16 Dec 2021)
- Policy for Obtaining Informed Consent of Potential Participants for Oncology Research (30 Aug 2023)
- Policy for External Adverse Event Report Management (10 Oct 2019)
- Policy for External Monitoring Visits conducted at the HDFCCC (22 Sept 2023)
- Policy for Classification of CRCs as RSS in Therapeutic Industry Trials (31 Oct 2014)
- Policy for Delegation of Authority Log (01 Dec 2018)
- Policy for Centralized IND/IDE Management (06 May 2022)
- Policy on Minimum Standards for Partnerships with International Clinical Research Organizations (CROs) (09 Sep 2021)
- Policy for Protocol Development and Maintenance of Investigator-Initiated Trials at UCSF (23 Oct 2019)
- Policy for Facilitating FDA Inspections (06 Feb 2023)
- Policy for Investigator Training (05 Sept 2023)
Expanded Access
- Policy for Single and Multi-Patient Expanded Access Treatment (20 March 2022)