Policies

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 Committee Membership Policy (Updated 06/22/2015)
• Protocol Review 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
• 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

• Policy for Single and Multi-Patient Expanded Access Treatment (v.3 10/09/2019)