CLINICAL TRIALS SHARED RESOURCE

临床试验共享资源（CTSR）在VICC的许多要素中促进和提高临床试验实施的效率。它提供了关键的人力资源和福利，包括为经验不足和经验丰富的研究人员提供培训，以准备监管审查和预算制定的方案。CTSR的主要职责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的主要使命是协助VICC研究者以高效、经济和技术合理的方式开发、启动和完成具有科学价值的临床试验。Jeffrey Sosman博士是CTSR的医学总监。他是由凯利威伦伯格，R。N.，负责CTSR日常运营的临床总监和负责方案激活和实施的大卫布朗宁。许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.