The Protocol Review and Monitoring System (PRMS) of the CRCH has been developed to evaluate the scientific merit, priority and progress of all clinical trials involving cancer patients. The PRMS is actually the second level of review, with the first being that of the Clinical Research Advocacy Board (CRAB). The CRAB is composed of community clinicians as well as Cancer Center investigators and has as its charge to evaluate the community interest and capability to enroll patients onto a given clinical trial. The CRAB review is important for this very decentralized clinical trial effort and provides the community clinicians feedback on accrual rates and potential new trials. Protocols can not be submitted to the various University and hospital IRBs until approved by both the CRAB and PRMS committees. A more limited subcommittee review is utilized for cooperative group protocols and pre-award, protocol concept review. The PRMS committee is also responsible for monitoring all of the active clinical trials, with reviews of annual reports for adverse events, accrual levels, and protocol modifications. Ten percent of all protocols are randomly selected for an audit each year. Appropriate criteria are in place for protocol termination, including inadequate accrual, excessive adverse events, and poor quality of the research conducted. The PRMS Committee is multidisciplinary in composition, drawing on active investigators from clinical oncology, biostatistics, nursing, and social science. The chair of the PRMS Committee, currently Dr. Brian Issell, is appointed by the Cancer Center Director. Appointments of the members are made for two year terms, with annual review. The PRMS committee meets monthly and the Center's Clinical Trials Unit serves as the administrative headquarters for the committee and all PRMS records.
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