Core--Clinical trials office

核心--临床试验办公室

• 批准号: 6395768
• 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/6395768
• 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）的主要任务是协助癌症中心研究人员以有组织的，成本效益且方法上的合理方式开发，激活和完整的科学有效临床试验。 为了提高临床试验支持人员的效率，所有从事癌症临床试验活动的机构数据经理，研究护士和文职人员在Barbara Murphy博士和Debbie Wujcik，R.N. CTSR旨在促进研究人员发起的研究。 CTSR的主要责任领域包括：1）协议支持服务，包括协议激活和监视，2）提供数据管理服务和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，将服务分为三类：核心服务，数据管理服务和研究护理服务。 CTSR努力促进特定调查领域的科学合理研究计划。 这是通过特定于疾病的特定研究团队来实现的，这些研究团队由医师，数据经理，护士和相关人员组成，对特定的恶性肿瘤或类别的恶性肿瘤（例如胸部肿瘤学）有兴趣。 研究团队负责：1）协议审查和计划开发； 2）通过IRB和科学审查委员会激活协议； 3）合格患者的识别，同意和注册； 4）数据采集，数据管理和质量控制； 5）向参与的VCC调查人员提供协议信息。 在CTSR员工的协助下，医师团队负责人会议定期会议，在此期间，对协议应计信息，数据管理活动以及工作量和不良事件进行了审查。 此外，团队审查和评估新协议，设置计划和研究优先级，并就资源分配做出决定。