Clinical Research

临床研究

• 批准号: 6989460
• 负责人: RAYMOND P PEREZ
• 金额: $ 8.77万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-02 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6989460
• 关键词: biomedical facility; clinical research; neoplasm /cancer

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.

临床研究办公室共享资源（CRO）负责监督Norris Cotton癌症中心临床试验的审查、启动、实施和安全性监测。CRO组成部分包括：1）行政人员，包括共享资源总监、副总监、助理总监、财务经理和方案助理; 2）方案特定研究支持人员，包括研究药剂师、药房技术员、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;和4）达特茅斯-希区柯克肿瘤登记处，由三名登记员组成。虽然DHMC和NCCC已经指定CRO作为负责临床癌症研究所有方面（包括医院肿瘤登记）的行政监督的办公室，但我们对CCSG资金的要求更狭窄。 此共享资源的定义功能与支持癌症治疗和化学预防的同行评审临床试验有关。CRO负责维护当地达特茅斯医学院研究、工作组研究、合作组方案和工业试验。其负责协助格式化方案、撰写知情同意书、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、激活方案、评估合格性、制定数据收集表以及 数据库，收集和管理数据。临床试验的优先顺序由12个NCCC临床肿瘤组确定，并得到CCRC的批准。CRO在方案启动前充当检查点，以确保试验的所有适当管理方面均已完成。CRO的收费政策准确反映了使用情况，并基于审查和批准的方案的患者应计费用。