CLINICAL TRIALS SHARED RESOURCE

临床试验共享资源

• 批准号: 6990192
• 负责人: Jeffrey A Sosman
• 金额: $ 23.21万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-28 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990192
• 关键词: biomedical facility; clinical trials; data management; neoplasm /cancer

The Clinical Trials Shared Resource (CTSR) facilitates and enhances the efficiency of clinical trial conduct among the many elements of the VICC. It provides critical human resources and benefits including training for inexperienced and experienced investigators in the preparation of protocols for regulatory review and budget development. The major areas of responsibility of the CTSR include support for all regulatory requirements such as IRB submissions and annual reporting, IND submissions and annual reporting, as well as assistance with protocol submissions to the Scientific Review Committee, the GCRC and the NCI; assistance with budget development and contract negotiations and resolution of problems pertaining to resource allocations; data management for all SRC-approved clinical trials; and provision of research nursing support as required by the clinical protocol. In order to meet these goals, CTSR services are grouped into three categories: Shared Resource Services, Data Management Services, and Research Nursing Services. In sum, the primary mission of the CTSR is to assist VICC investigators in developing, activating, and completing scientifically meritorious clinical trials in an efficient, cost-effective, and technically sound manner. Dr. Jeffrey Sosman is the Medical Director of the CTSR. He is assisted by Kelly Willenberg, R. N., the Clinical Director, who is responsible for the day-to-day operations of the CTSR and David Browning, who handles protocol activation and implementation. A multitude of other staff provides support for the widely varying functions of the Clinical Trials Shared Resource.

临床试验共享资源 (CTSR) 促进并提高了 VICC 众多要素中临床试验实施的效率。它提供了关键的人力资源和福利，包括为缺乏经验和经验丰富的研究人员提供培训，以制定监管审查和预算制定方案。 CTSR 的主要职责领域包括支持所有监管要求，例如 IRB 提交和年度报告、IND 提交和年度报告，以及协助向科学审查委员会、GCRC 和 NCI 提交方案；协助预算制定和合同谈判以及解决与资源分配有关的问题；所有 SRC 批准的临床试验的数据管理；并根据临床方案的要求提供研究护理支持。为了实现这些目标，CTSR 服务分为三类：共享资源服务、数据管理服务和研究护理服务。总之，CTSR 的主要任务是协助 VICC 研究人员以高效、经济且技术可靠的方式开发、启动和完成具有科学价值的临床试验。 Jeffrey Sosman 博士是 CTSR 的医疗主任。他由负责 CTSR 日常运营的临床主任 Kelly Willenberg, R. N. 和负责方案激活和实施的 David Browning 协助。许多其他工作人员为广泛的工作提供支持 临床试验共享资源的不同功能。