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。CTSR汇集了关键的人力资源，有助于确保所有关键研究人员的培训标准化，包括医生、研究护士、数据管理和监管人员。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提交方案。此外，CTSR还协助制定预算、进行合同谈判和解决与资源分配有关的问题。根据临床方案的要求，CTSR还提供所有临床试验和研究护理支持的数据管理。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。 乔丹·伯林博士是CTSR的医务主任。他得到了执行主任黛布拉·亚当森的协助，她负责CTSR的日常运作。许多其他工作人员为这一共享资源的广泛不同功能提供支持。

The Clinical Trials Shared Resource (CTSR) facilitates and enhances the efficiency of clinical trial conduct among the many elements of the VICC. The CTSR brings together critical human resources that help ensure standardization of training of all key research personnel including physicians, research nurses, data management and regulatory staff. The major areas of responsibility of the CTSR include support for all of the 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. In addition, the CTSR provides assistance with budget development, contract negotiations, and resolution of problems pertaining to resource allocations. The CTSR also provides data management for all clinical trials and research nursing support as required by the clinical protocol. 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. Jordan Berlin is the Medical Director of the CTSR. He is assisted by Debra Adamson, M.S., the Executive Director, who is responsible for the day-to-day operations of the CTSR. A multitude of other staff provides support for the widely varying functions of this Shared Resource.