CLINICAL TRIALS SHARED RESOURCE

临床试验共享资源(CTSR)在VICC的许多元素中促进和提高临床试验的进行效率。它提供重要的人力资源和好处，包括对缺乏经验和有经验的调查员进行培训，使他们能够拟定监管审查和预算编制程序。CTSR的主要职责领域包括支持所有监管要求，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提交协议；协助预算制定和合同谈判，解决与资源分配有关的问题；为SRC批准的所有临床试验进行数据管理；以及根据临床协议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。总而言之，CTSR的主要任务是协助VICC研究人员以高效、成本效益和技术健全的方式开发、激活和完成具有科学价值的临床试验。杰弗里·索斯曼博士是CTSR的医学主任。他得到了临床主任Kelly Willenberg和David Browning的协助，Kelly Willenberg是临床主任，负责CTSR的日常操作，David Browning负责方案的激活和实施。众多其他工作人员为广泛的 临床试验共享资源的不同功能。

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.