Protocol Review and Monitoring System

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PROJECT SUMMARY (See instructions): The goals of the Protocol Review and Monitoring System (PRMS) are accomplished by the Clinical Research Committee (CRC) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). CRC reviews all new cancer protocols for scientific merit, methodology, adequacy of human resources, funding, and reasonableness of accrual goals before submission to the Institutional Review Board (IRB) of the University of Maryland School of Medicine at the University of Maryland-Baltimore (UMB). CRC ensures for all institutionally originated protocols that expert biostatistical planning has occurred, and monitors all protocols for early closure if accrual is not proceeding or if scientific or safety issues arise. CRC provides review as needed of Medicare coverage and PI determinations of research versus standard of care procedures. CRC works with disease groups to ensure proper prioritization for effort of proposed versus existing protocols. CRC considers the actual accrual of underserved minorities to UMGCC protocols on a periodic basis with Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program and community outreach liaison for clinical research, to ensure at least congruence with UMGCC's catchment demographic profile. CRC reviews the adequacy of the proposed Data Safety Monitoring (DSM) plan and stipulates the frequency and intensity of review by the DSM/Quality Assurance Committee. During calendar year (CY) 2009, CRC reviewed 61 protocols: 7 were approved as written; 42 were approved with minor modifications; 8 were approved with major modifications and required another review; 2 were deferred for reconsideration because of issues raised by the review process; and 2 were disapproved. An expedited review process exists for minimal risk non-interventional studies; that process approved nine studies in CY2009. The full CRC does not directly review technology-related protocols without treatment intent from Radiation Oncology. Such reviews are delegated to a specialized subcommittee of CRC, the Technology Research Review Committee. During CY2009, 113 trials were monitored for accrual, targeting for corrective action protocols that were not accruing at a rate suggesting successful completion within a 3- to 5-year time frame. Twenty three warning letters were issued. As of August 2010, CRC had closed eight protocols as a result of this process.