Clinical Research Policies
Site Committee
- Site Committee Membership Policy (Updated 1/27/2020)
- Site Committee Review Policy (Updated 11/18/2016)
- Site Committee Selection Policy (Updated 9/12/2019)
Protocol Review and Monitoring Committee
- Protocol Review and Monitoring Committee Membership Policy (Updated 06/22/2015)
- 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)
- DSMC Guidance for Notification of Mandatory Holds (v. 2 July 2015)
- Requirement for the Notification of the DSMC for SNC Reports (v. 05 May 2017)
- Guidance for OnCore eCRF Approval Prior to the Start of Enrollment
- Guidance for Completion of Baseline Conditions
Policies
- Policy for Obtaining Informed Consent of Potential Patients for Therapeutic and Non-Therapeutic Oncology Clinical Trials (v.8 July 2016)
- Policy for Fellows Obtaining Informed Consent
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Policy for Verbal Notification of New High-Risk Adverse Events (v.2, 21 Oct 2019)
- Policy for External Adverse Event Report Management ( v.1, 10OCT2019)
- Policy for External Monitoring Visits conducted at the HDFCCC (v.1 17Sept2019)
- Policy for Classification of CRCs as RSS in Therapeutic Industry Trials (v. 31Oct2014)
- Policy for Delegation of Authority Log (v. 2018Dec01)
- Policy for Centralized IND/IDE Management
- Policy on Minimum Standards for Partnerships with International Clinical Research Organizations (CROs) (v.1 07Dec2018)
- Policy for Protocol Development and Maintenance of Investigator-Initiated Trials at UCSF (v.1 10/23/2019)
- Policy for Cost Language in Informed Consent Forms (ICFs) (v.1 8.16.19)
- Policy for External Reviewer Request for Access to Electronic Medical Record (v. 2 24Sep2019)
- Policy for Facilitating FDA Inspections (v. 25 Mar 2020)
Expanded Access