Statistics and Data Management Center-CSCC

统计数据管理中心

• 批准号: 6504666
• 负责人: Ronald W. Helms
• 金额: $ 465万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6504666
• 关键词: clinical research; computer program /software; cooperative study; data collection methodology /evaluation; data management; health care referral /consultation; health care service utilization; health economics; health science research support; informatics; outcomes research; patient care management; quality of life; sickle cell anemia; social support network; statistics /biometry

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 位于北卡罗来纳州教堂山的 Rho Federal Systems Division, Inc. (RhoFED) 建议继续担任综合镰状细胞中心 (CSCC) 计划的统计和数据管理中心 (SDMC)。 SDMC 将充当协调中心，支持合作临床研究、当地基础和临床研究以及促进 CSCC 参与者和 NHLBI 项目办公室之间最佳沟通的活动。 这些研究将重点关注镰状细胞病最有前途的治疗方式。 协调中心的主要目标是充当研究组日常活动的沟通中心，提供科学要素方面的流行病学和统计协作，并提供工具和支持以确保临床中心生成的数据具有最高质量。 RhoFED 认为以下四个目标对于满足该项目的操作和科学要求至关重要： a) 为 CSCC 项目的通用临床方案提供数据管理、统计领导和临床运营管理支持； 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 CSCC 计划内各机构之间的通信，并确保协作临床研究的数据输入和数据管理的安全； d) 维护、扩展和改进现有的 CSCC 计划通用患者数据库，特别强调纳入有关镰状细胞病患者社会和经济负担的数据以及与卫生服务利用、健康结果和生活质量相关的数据。