The NCI requires that each Cancer Center have 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 Center.
While the centralized oversight is provided by the Protocol Review Committee (PRC), the Helen Diller Family Comprehensive Cancer Center provides for additional disease-specific input via the various Site Committees. These Site Committees are charged with the contextual review, feasibility assessment and prioritization of each new concept and protocol as it relates to the patient populations and research focus of each Site Committee. They consider relevant clinical programs, programmatic goals, expertise, and research interests in assessing both concepts and protocols. A protocol cannot move forward for review by the Protocol Review Committee (PRC) unless it has full approval from at least one Site Committee.
All studies reviewed by a Site Committee will be subject to:
- prioritization in relation to all other studies reviewed by the committee
- identifying competing protocols
- setting and justifying the accrual goals for each protocol
- monthly safety review (weekly for phase I, early phase, or other high-risk clinical trials)
- required review of all protocol amendments
- annual review for accrual
- possible closure for poor accrual.
Multiple Site Committees exist covering all disease areas, including one for supportive care and one for early phase trials.
- identify the patient population relevant to your protocol
- view the list of committees and select the committee that best matches your patient population (if your protocol attempts to alleviate a symptom of cancer as opposed to the cancer itself, use the Supportive Care site committee )
- contact the administrator for that committee. They will provide information on what is needed for submission as well as potential review dates.
Forms and Policies
> see Site Committee Forms
> for Site Committee review process policies see ITR Policies
This unit is supported by a National Cancer Institute Cancer Center Support Grant (P30CA082103). Any publications related to work done by this core should reference grant number P30CA082103 and must include a PMCID as required by the NIH. View instructions on how to acknowledge funding sources and how to obtain a PMCID.
For inquiries about Cancer Center Shared Resources, please email Benjamin Braun, MD, PhD.
For more information on the CCSG, please email Erin Bank, PhD.