Clinical Research Shared Service

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Clinical Research Shared Service The Clinical Research Shared Service (CRSS) is the central set of personnel, resources, and processes that supports the design, development, and implementation of clinical protocols and interactions among review committees, including the University of Maryland School of Medicine's (UMSOM's) Institutional Review Board (IRB), for clinical investigators working in all programs at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). The Clinical Research Oversight Committee provides guidance on resources that are apportioned by CRSS. CRSS facilitates interactions between UMGCC's basic science investigators and clinical investigators. CRSS supports investigators in initiating the scientific review of their protocols, which is performed by UMGCC's Clinical Research Committee (CRC) before the protocol is submitted to the IRB. For protocols without an external Data Safety Monitoring (DSM) process, the CRSS also supports investigators in their interactions with UMGCC's DSM/Quality Assurance Committee (DSM/QAC). For Fiscal Year 2008 (FY08), the total projected budget for CRSS is $2,475,926: $581,315 (23 percent) from institutional support through UMGCC's funds; $764,213 (31 percent) from the University of Maryland Medical System; and $1,130,398 (46 percent) from peer-reviewed grants and industrial trials. The CRSS has been revised extensively since the last core grant application from UMGCC: installed new leadership; formalized a process for reviewing accrual to UMGCC protocols; revamped the DSM/QAC process that has been synchronized with reviews of the IRB; dedicated an effort to track and promote underserved minority participation in clinical trials; and acquired and implemented the Oncore¿ database to track demographics and milestones pertaining to adverse events and clinical trials. For FY07, UMGCC's portfolio of active and accruing protocols included 146 therapeutic trials and 65 nontherapeutic trials. CRSS uses the services of approximately 29.33 full-time equivalents, including 1 manager, 15 research coordinators, 5 data managers or data assistants, and 8.33 regulatory support staff. During FY07, 242 new patients were accrued to therapeutic trials; 704 new patients were accrued to nontherapeutic trials; and more than 2,000 patients were being followed as part of ongoing research studies.