Statistics and Data Management Center-CSCC

位于北卡罗来纳州教堂山的Rho Federal Systems部门，Inc.(RhoFED)提议继续服务 作为综合镰刀细胞中心(CSCC)的统计和数据管理中心(SDMC) 程序。国家临床医学中心将作为一个协调中心，支持协作性临床研究、当地基础和 临床研究和活动，促进CSCC参与者和NHLBI之间的最佳沟通 项目办公室。这些研究将集中在最有希望的镰状细胞疾病的治疗方式上。这个 协调中心的主要目标是作为以下机构日常活动的中心联络点 研究小组，在科学要素方面提供流行病学和统计合作，并提供 工具和支持，以确保临床站点生成的数据具有最高质量。RhoFED考虑 以下四个目标对于满足该项目的业务和科学要求至关重要： A)为公共部门提供数据管理、统计领导和临床业务管理支持 CSCC计划的临床方案； B)为CSCC计划内的所有研究项目提供统计支持； C)开发、实施和维护基于网络的信息技术，以促进各设施之间的交流 在CSCC计划内，为协作临床研究提供安全的数据输入和数据管理； D)维护、扩展和改进现有的CSCC方案共同患者数据库，重点放在 纳入关于患有镰状细胞病的社会和财政负担的数据以及与健康有关的数据 服务利用率、健康结果和生活质量。

Rho Federal Systems Division, Inc. (RhoFED), located in Chapel Hill, North Carolina, proposes to continue to serve as the Statistics and Data Management Center (SDMC) for the Comprehensive Sickle Cell Centers (CSCC) program. The SDMC will act as a coordinating center in support of collaborative clinical studies, local basic and clinical research, and activities to promote optimal communication among CSCC participants and the NHLBI Project Office. These studies will focus on the most promising therapeutic modalities for sickle cell disease. The primary goals of the coordinating center are to act as central point of communication for the day-to-day activities of the study group, provide epidemiological and statistical collaboration in the scientific elements, and provide the tools and support to ensure that the data generated by the clinical sites are of highest quality. RhoFED considers the following four aims to be essential in meeting the operational and scientific requirements of the project: a) Provide data management, statistical leadership, and clinical operations management support for common clinical protocols for the CSCC program; b) provide statistical support for all research projects within the CSCC program; c) develop, implement, and maintain web-based information technology to facilitate communication across facilities within the CSCC program and secure data entry and data management for the collaborative clinical studies; d) Maintain, expand, and improve the existing CSCC program common patient database with particular emphasis on incorporating data on the social and financial burden of living with sickle cell disease and data related to health services utilization, health outcomes, and quality of life.