Clinical Research

临床研究办公室共享资源(CRO)监督诺里斯·科顿癌症中心临床试验的审查、启动、实施和安全监测。CRO的组成部分是1)行政人员，包括共享资源主任、副主任、助理主任、财务经理和礼宾助理；2)专门针对方案的研究支持人员，包括一名研究药剂师、一名药房技师、两名研究注册护士和16名临床研究助理/协调员；3)方案审查和监测系统，由临床癌症研究委员会(CCRC)和安全和数据监测委员会(SDMC)组成；以及4)达特茅斯-希区柯克肿瘤登记中心，由三名登记人员组成。虽然DHMC和NCCC已经指定CRO作为负责临床癌症研究所有方面的行政监督的办公室，包括医院肿瘤登记，但我们对CCSG的资助请求是为了更狭隘的范围 这一共享资源的明确功能与支持同行评审的癌症治疗和化学预防临床试验有关。CRO维护当地达特茅斯医学院的研究、工作组研究、合作小组协议和工业试验。它负责协助格式化方案、撰写同意书、维护机构审查委员会和SDMC记录、制定预算、评估对机构资源的影响、启动方案、评估资格、编制数据收集表格和 数据库，以及收集和管理数据。临床试验的优先顺序是在12个NCCC临床肿瘤学小组中确定的，并得到CCRC的批准。CRO在启动方案之前充当检查站，以确保完成试验的所有适当行政方面。CRO的按存储容量使用计费政策准确地反映了使用情况，并基于患者对已审查和批准的方案的应计费用。

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.