CORE--CLINICAL RESEARCH OFFICE

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The Clinical Research Office Shared Resource (CRO) oversees the review, initiation, conduct, and safety monitoring of clinical trials at the Norris Cotton Cancer Center. The CRO components are (l) an administrative staff including the Shared Resource Director, an Associate Director, an Assistant Director, and a Protocol Assistant; (2) the Protocol-Specific Research Support staff, comprising a research pharmacist, a pharmacy technician, two research registered nurses, and nine clinical research assistants; (3) the Protocol Review and Monitoring System, consisting of the Clinical Cancer Research Committee (CCRC) and the Safety and Data Monitoring Committee (SDMC); and (4) the Mary Hitchcock Memorial Hospital Tumor Registry, staffed by two registrars. Although DHMC and the NCCC have designated the CRO as the office responsible for administrative oversight of all aspects of clinical cancer research including the hospital tumor registry, our request is for CCSG funding of the more narrowly defined functions of this Shared Resource, as described in the CCSG proposal, which relate only to support of peer-reviewed clinical trials of cancer treatment and chemoprevention. The CRO maintains local Dartmouth Medical School studies, working group studies, cooperative group protocols, and industrial trials. It is responsible for assisting in formatting protocols, writing consent forms, maintaining Institutional Review Board and SDMC records, developing budgets, assessing impact on institutional resources, activating protocols, assessing eligibility, developing data collection forms, and collecting and managing data. Prioritization of clinical trials is determined within the 10 NCCC Disease Management Groups, with approval by the CCRC. The CRO acts as a checkpoint prior to activation of protocols to ensure all appropriate administrative aspects of trials are complete. Charge-back policies of the CRO accurately reflect usage and are based on patient accrual to reviewed and approved protocols.