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 1) an administrative staff including the Shared Resource Director, an Associate Director, an Assistant Director, a financial manager, and a protocol assistant; 2) the Protocol-Specific Research Support staff, comprising a research pharmacist, a pharmacy technician, two research registered nurses, and 16 clinical research assistants / coordinators; 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 Dartmouth-Hitchcock Tumor Registry, staffed by three 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 for CCSG funding is for the more narrowly defined functions of this Shared Resource related to support 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 databases, and collecting and managing data. Prioritization of clinical trials is determined within the 12 NCCC Clinical Oncology Groups, with approval by the CCRC. The CRO acts as a checkpoint prior to activation of protocols to ensure that 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.
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