Clinical Research Shared Services

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The Clinical Research Shared Service (CRSS) participates with members of clinical teams and investigators on all details of clinical trial design, review, implementation, and preparation for quality assurance monitoring, including interactions with the Institutional Review Board of the University of Maryland School of Medicine, the Clinical Research Committee (CRC) (or Protocol Review and Monitoring System) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC), and the Data Safety Monitoring/Quality Assurance Committee of UMGCC. In addition, CRSS participates in negotiating with sponsors to develop budgets for clinical trials in conjunction with the Office of Research and Development at the University of Maryland-Baltimore (UMB). CRSS utilizes and manages the Oncore¿ database for all patients¿completing case report forms for industry-sponsored studies and entering data into appropriate databases for Phase I or Phase 11 trials sponsored by the National Cancer Institute and cooperative group sponsored trials. Oncore¿ is also utilized for customized case report forms in investigator-initiated protocols. CRSS also collects information and forwards records of underserved minority accrual to clinical trials to Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program, to facilitate periodic reviews in conjunction with CRC. Dr. Ntiri serves as the liaison for clinical research community outreach. During fiscal year 2010 CRSS costs were $3,325,306, of which $280,124 were from the Cancer Center Support Grant and $358,876 were from other peer-reviewed grant support. During the latest 3-year grant period, 37 publications were supported by CRSS, serving the Hormone Responsive Cancers and Experimental Therapeutics Programs at UMGCC.