Core--Clinical trials office

核心--临床试验办公室

• 批准号: 6396877
• 负责人: Barbara A. Murphy
• 金额: --
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-01 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6396877
• 关键词: biomedical facility; clinical trials; health science research support; neoplasm /cancer; oncology

The primary mission of the Clinical Trials Shared Resource (CTSR) is to assist Cancer Center investigators develop, activate and complete scientifically valid clinical trials in an organized, cost-effective and methodologically sound manner. To enhance the efficiency of clinical trials support staff, all institutional data managers, research nurses and clerical staff engaged in cancer clinical trials activity have been consolidated into a shared resource under the direction of Dr. Barbara Murphy and Ms. Debbie Wujcik, R.N., M.S.N.. This consolidation permits pooling of support dollars as well allowing for maximum utilization of such funding. The CTSR is designed to facilitate investigator- initiated research. The major areas of responsibility of the CTSR include: 1) protocol support services including protocol activation and monitoring, 2) provision of data management services and 3) provision of research nursing support. In order to provide these services in an organized and uniform manner, services have been grouped into three categories: Core Services, Data Management Services, and Research Nursing Services. The CTSR strives to facilitate scientifically sound research programs in specific areas of investigation. This is accomplished through disease-specific and modality-specific research teams which consist of physician investigators, data managers, nurses and associated staff with an interest in specific malignancy or category of malignancies (e.g. thoracic oncology). Research teams are responsible for: 1) protocol review and program development; 2) protocol activation through the IRB and scientific review committees; 3) identification, consent and registration of eligible patients; 4) data acquisition, data management and quality control; and 5) provision of protocol information to participating VCC investigators. With the assistance of CTSR staff, physician team leaders convene regular meetings during which there is review of protocol accrual information, data management activities and workload and adverse events. In addition, the teams review and evaluate new protocols, set program and study priorities, and make decisions regarding resource allocation.

临床试验共享资源(CTSR)的主要任务是帮助癌症中心的研究人员以有组织、有成本效益和方法合理的方式开发、激活和完成科学有效的临床试验。为了提高临床试验支持人员的效率，在Barbara Murphy博士和Debbie Wojcik女士，R.N.，M.S.N.的指导下，所有从事癌症临床试验活动的机构数据经理、研究护士和文书人员被整合为一个共享资源。这种合并还允许汇集支助资金，从而最大限度地利用这种资金。CTSR旨在促进调查人员发起的研究。CTSR的主要职责领域包括：1)协议支持服务，包括协议激活和监测；2)提供数据管理服务；3)提供研究护理支持。为了以有组织和统一的方式提供这些服务，服务被分为三类：核心服务、数据管理服务和研究护理服务。CTSR努力促进在特定调查领域开展科学合理的研究计划。这是通过特定疾病和特定模式的研究团队完成的，研究团队由对特定恶性肿瘤或恶性肿瘤类别(例如胸腔肿瘤学)感兴趣的医生调查人员、数据经理、护士和相关工作人员组成。研究团队负责：1)方案审查和计划开发；2)通过IRB和科学审查委员会激活方案；3)确认、同意和登记符合条件的患者；4)数据获取、数据管理和质量控制；以及5)向参与的VCC调查人员提供方案信息。在CTSR工作人员的协助下，医生团队负责人定期召开会议，在此期间审查方案应计信息、数据管理活动以及工作量和不良事件。此外，这些团队还审查和评估新的协议，设定计划和研究的优先顺序，并就资源分配做出决定。