CLINICAL TRIALS SHARED RESOURCE

点击翻译按钮获取中文摘要

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.