Protocol Review Committee
Protocol Review Committee (PRC)
The NCI requires that each Cancer Center maintain a Protocol Review and Monitoring System (PRMS) to assess scientific merit and feasibility of all protocols studying subjects diagnosed with, or at risk for, cancer conducted at the Center, and to monitor for accrual and scientific relevance. NCI looks for centralized oversight across the entire Center; the Protocol Review Committee (PRC) serves as the centralized portion of this requirement (as opposed to the Site Committees).
The PRC is charged with review of the scientific rationale, study design, expected accrual rates, adequacy of biostatistical input, feasibility for completion within a reasonable time period, prioritization in terms of scientific merit and patient availability, and review of scientific progress including reasonable study goals and accrual rates. The PRC has final authority regarding protocol and amendment review and approval, accrual monitoring, and study closure. The UCSF IRB, the UCSF IRB, will not grant initial approval for any cancer-related study until the PRC has granted full approval or exemption, and may hold up approval of a protocol amendment if not reviewed by the PRC prior to IRB review.
All studies reviewed by the PRC will be subject to:
- prioritization score independent of that from the Site Committee
- required review of all protocol amendments
- annual review for scientific relevance and accrual
- closure due to lack of scientific relevance and/or poor accrual.
- Make sure you have a site committee review scheduled first – see Site Committees
Obtain an OnCore account:
- An OnCore account is required to apply for scientific review at the HDFCCC Protocol Review Committee (PRC). If you do not have an OnCore account, apply for one by completing the survey.
The survey will ask what role(s) you need -- you must have the PM role in order to apply for PRC review. If you will also be managing subject enrollments, placing orders in APeX, etc., then you also need the CRA role. Role definitions:
- Your OnCore account will not be activated until you complete the ePRMS training for PM role, as well as the OnCore Subject Enrollment training (if you need the CRA role). Training videos are available through the UC Learning Management System.
- Submit your study for PRC review in OnCore by following the instructions in the UCSF OnCore Wiki. If you have specific questions after reading the Wiki, contact the PRC Administrator or PRMS Manager for the quickest response, or email@example.com (please note, this email Inbox is not checked daily).
Email firstname.lastname@example.org with any questions.
- 2020 PRC Recommended Submit Dates
- 2020 PRC Meeting Schedule
- Site Committee Chairs and Administrators
- Protocol Review Committee roster
Forms and Policies