CLINICAL TRIALS AND INFORMATION MANAGEMENT SUPPORT

本合同的目的是在临床试验概念和研究的发展过程中为CTEP和CCCT专业人员提供评估、协调和监督方面的支持。承包商还将参与获取、审查和分析CTEP赞助的外部临床研究产生的数据和信息，提供项目管理支持以确保CTEP赞助的试验得到及时审查和启动，并为指导委员会会议、工作组和工作组会议、概念评估和临床试验规划会议(CTPM)的协调和监督提供行政支持。 癌症治疗评估计划(CTEP)负责管理、协调和科学审查由癌症治疗和诊断部(DCTD)支持的大多数外部临床试验。这些计划包括DCTD临床试验合作小组计划、早期药物开发计划合作协议和合同持有人、研究人员发起的赠款和与癌症治疗有关的合作协议的接受者以及研究试剂的接受者。此外，CTEP正在实施国家癌症咨询委员会临床试验工作组(CTWG)提出的建议，以重组NCI的临床试验企业，以实现分子肿瘤学在21世纪的前景。NCI临床试验协调中心(CCCT)指导CTWG建议的实施。CTEP与CCCT合作，领导实施科学指导委员会，以提高临床试验的科学质量和优先顺序。

The purpose of this contract is to provide support to the CTEP and CCCT Professional Staff in the evaluation, coordination and oversight of clinical trial concepts and studies as they develop. The Contractor will also be involved with the acquisition, review and analysis of data and information which result from CTEP-sponsored extramural clinical research, providing project management support to ensure that CTEP-sponsored trials are reviewed and activated in a timely manner, and providing administrative support for the coordination and oversight of steering committee meetings, task force and working group meetings, concept evaluations, and Clinical Trials Planning meetings (CTPMs). The Cancer Therapy Evaluation Program (CTEP) is responsible for the administration, coordination, and scientific review of most of the extramural clinical trials supported by the Division of Cancer Treatment and Diagnosis (DCTD). These programs include the activities of the DCTD Clinical Trials Cooperative Group Program, the Early Drug Development Program cooperative agreement and contract holders, the recipients of investigator-initiated grants and cooperative agreements relating to cancer treatment and the recipients of investigational agents. In addition, CTEP is implementing recommendations made by the National Cancer Advisory Board's Clinical Trials Working Group (CTWG) to restructure the NCI's clinical trials enterprise to realize the promise of molecular oncology in the 21st century. NCI's Coordinating Center for Clinical Trials (CCCT) guides the implementation of the CTWG recommendations. CTEP collaborates with CCCT in leading the implementation of Scientific Steering Committees to enhance scientific quality and prioritization of clinical trials.