OFFICE OF CLINICAL RESEARCH

临床研究办公室(OCR)协调审查、启动、实施和安全监测 在莫里斯棉花癌症中心进行的临床试验。OCR现在是临床试验的一个分支 达特茅斯医学院办公室(CTO)。OCR最近在订单方面经历了戏剧性的扩展 以更好地适应癌症中心内的临床研究需求。OCR的组件有(1) 行政工作人员，包括医务主任、行政主任、监管合规性 干事和临床业务协调员；(2)研究支助人员？研究药剂师， 药房技术员、6个研究RN和24个临床研究助理/协调员；(3)与 由临床肿瘤研究委员会(CCRC)组成的方案审查和监测系统 和安全和数据监测委员会(SDMC)；(4)机构资助的达特茅斯-希区柯克 肿瘤登记系统，由三个登记员组成；和(5)临床试验管理系统(VELOS EResearch)。 OCR维护当地达特茅斯医学院研究员发起的研究，达特茅斯研究员发起的研究 研究依赖于工作组注册地点、合作小组协议和 工业试验。它负责协助格式化协议、编写同意书、维护 机构审查委员会(CPHS)和SDMC记录，制定预算，评估对 机构资源、激活方案、评估资格、开发数据收集表格和临床 试验数据库，以及收集和管理数据。致力于研究和临床试验登记 支持已整合到目前达特茅斯-希区柯克医疗中心的扩建中 临床设施的区域网络。临床试验的优先顺序在11项NCCC临床试验中确定 肿瘤学小组，经中国证监会批准。OCR充当协议激活之前的检查点 确保完成审判的所有适当行政方面。OCR按存储容量使用计费策略 准确地反映使用情况，并基于患者对审查和批准的方案的应计费用。对于 截至2007年11月30日的CCSG财年，OCR支持了215项活动试验。这些试验代表了 为32个不同的PI提供服务。在此期间，对这些研究的支持包括484项新登记 之前登记的1,876名患者的患者和随访。关于我们的最新报告期 肿瘤登记在2006年，我们进入了2582名(1990年)患者中的487名进行治疗试验。在整个奖项中 在此期间，进入干预试验的患者中约有40%是机构试验。

The Office of Clinical Research (OCR) coordinates the review, initiation, conduct, and safety monitoring of clinical trials at the Morris Cotton Cancer Center. The OCR now functions as a branch of the Clinical Trials Office (CTO) of Dartmouth Medical School. The OCR has recently undergone a dramatic expansion in order to better accommodate clinical research needs within the Cancer Center. Components of the OCR are (1) Administrative staff, including the Medical Director, the Administrative Director, the Regulatory Compliance Officer, and the Clinical Operations Coordinator; (2) Research Support staff¿a research pharmacist, a pharmacy technician, six research RNs, and 24 clinical research assistants/coordinators; (3) interface with the Protocol Review and Monitoring System, consisting of the Clinical Cancer Research Committee (CCRC) and the Safety and Data Monitoring Committee (SDMC); (4) the institutionally funded Dartmouth-Hitchcock Tumor Registry, staffed by three registrars; and (5) a Clinical Trials Management System (Velos eResearch). The OCR maintains local Dartmouth Medical School investigator-initiated studies, Dartmouth investigatorinitiated studies relying on a consortia of working group enrolling sites, cooperative group protocols, and industrial trials. It is responsible for assisting in formatting protocols, writing consent forms, maintaining Institutional Review Board (CPHS) and SDMC records, developing budgets, assessing impact on institutional resources, activating protocols, assessing eligibility, developing data collection forms and clinical trials databases, and collecting and managing data. A commitment to research and clinical trial enrollment support has been integrated into the current expansion of the Dartmouth-Hitchcock Medical Center into a regional network of clinical facilities. Prioritization of clinical trials is determined within the 11 NCCC Clinical Oncology Groups, with approval by the CCRC. The OCR acts as a checkpoint prior to activation of protocols to ensure that all appropriate administrative aspects of trials are complete. Chargeback policies of the OCR accurately reflect usage and are based on patient accrual to reviewed and approved protocols. For the CCSG fiscal year ending November 30, 2007, the OCR supported 215 active trials. These trials represented service to 32 different Pis. Support of these studies during this period included the new registration of 484 patients and follow-up for 1,876 patients previously enrolled. For the most recent reporting period for our tumor registry in 2006, we entered 487 of 2,582 (1990) patients on therapeutic trials. Throughout this award period, approximately 40% of patients entered onto intervention trials were accrued to institutional trials.