Protocol Review and Monitoring Committee

Protocol Review and Monitoring Committee (PRMC)

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 and Monitoring Committee (PRMC) serves as the centralized portion of this requirement (as opposed to the Site Committees).

The PRMC 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 PRMC has final authority regarding protocol and amendment review and approval, accrual monitoring, and study closure. The UCSF IRB will not grant initial approval for any cancer-related study until the PRMC has granted full approval or exemption, and may hold up approval of a protocol amendment if not reviewed by the PRMC prior to IRB review.

All studies reviewed by the PRMC 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.

To apply:

1. Make sure you have a site committee review scheduled first – see Site Committees
2. Obtain an OnCore account:
   • An OnCore account is required to apply for scientific review at the HDFCCC Protocol Review and Monitoring Committee (PRMC). If you do not have an OnCore account, apply for one here.
   • The form will ask what role(s) you need -- you must have the Protocol Manager role in order to apply for PRMC review. If you will also be managing subject enrollments, placing orders in APeX, etc., then you also need the Research Coordinator role. Role definitions: 
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   • Your OnCore account will not be activated until you complete the ePRMS training for the Protocol Manager role, as well as the OnCore Subject Enrollment training (if you need the Research Coordinator role).  Training videos are available through the UC Learning Management System.
3. Submit your study for PRMC review in OnCore by following the instructions in the UCSF OnCore Wiki. 
   • If you experience problems connecting to the Wiki, please consult this troubleshooting page. You may need to contact Wiki Administration for help.
   • If you have specific questions after reading the Wiki, contact the PRMS Administrator for the quickest response, or [email protected] (please note, this email Inbox is not checked daily).