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 Program/Disease 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 Committee on Human Research (CHR), 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 CHR review.
All studies reviewed by the PRC will be subject to: