NIH StrokeNet National Data Management Center (NDMC)

中风是一种致残性疾病，通常是致命的，影响所有年龄段的人，但主要是老年人。中风发病率 预计随着美国人口老龄化，这一数字将会上升。因此，它对公共卫生和卫生资源的影响 使用率将继续很高。中风进展审查小组和美国国家中风研究所 神经紊乱和中风(NINDS)已经确定了对中风临床试验中心网络的需求 为了确定优先顺序并有效地设计和实施探索性(第二阶段)临床试验和验证性试验 (第三阶段)确定和推进中风治疗的临床试验。NIH StrokeNet是一个多学科的 中风研究基础设施，包括国家临床协调中心、国家数据管理 国家发展和发展中心(NDMC)、25个区域协调中心和NINDS。它的使命是开发和测试新的 中风治疗、康复和预防的治疗方法可以减轻全球中风的负担。 国家发展和改革委员会的作用是与网络中涉及的所有各方建立合作关系，并 提供高效和标准化的中央数据管理，以产生高质量的数据和统计支持 在中风试验的计划和执行中。为此，医疗中心的数据协调股(DCU) 南卡罗来纳大学开发了基于Web的全面集成电子数据捕获和 临床试验管理系统WebDCU™，允许从参与的临床站点输入数据 广泛的数据质量控制，并提供有效管理业务活动的必要工具 对于并发的多项试验，同时确保符合NINDS公共数据元素和FDA 指导和规章。使用WebDCU系统，我们已经开发、实现和维护了一个 中央数据库，简化并最大限度地提高数据收集、处理、 以及监测临床、生物标志物和神经成像数据。此外，WebDCU™还包含试用版 为StrokeNet中的所有研究业务活动提供全面支持的管理信息系统。 NDMC的神经成像存储库包含需要集中审查的指定成像方案 所有StrokeNet试验。此外，还与该研究的首席调查员和 国家发改委生物统计学家StrokeNet：为创新和高效的方案制定作出贡献(包括 研究设计和病例报告表开发)；统计监测研究进展；生成报告 副秘书长和研究小组；进行中期和最终分析；通过演示和 出版物；以及创建公共使用数据集，以便在研究完成后共享数据。

Stroke is a disabling and often fatal disease that affects all ages, but mostly in the elderly. Stroke incidence is expected to rise in the US as its population ages. Therefore, its impact on public health and health resources utilization will continue to be significant. The Stroke Progress Review Group and the National Institute of Neurological Disorders and Stroke (NINDS) have identified a need for a network of stroke clinical trials centers in order to prioritize and efficiently design and conduct exploratory (Phase II) clinical trials and confirmatory (Phase III) clinical trials to identify and advance stroke treatments. The NIH StrokeNet is a multidisciplinary stroke research infrastructure that includes a National Clinical Coordinating Center, a National Data Management Center (NDMC), 25 Regional Coordinating Centers and the NINDS. Its mission is to develop and test new therapies for stroke treatment, recovery, and prevention that can decrease the global burden of stroke. The NDMC’s role is to establish a collaborative relationship with all parties involved in the Network and provide efficient and standardized central data management that yields high quality data and statistical support in the planning and execution of the stroke trials. To this end, the Data Coordination Unit (DCU) at the Medical University of South Carolina has developed a web-based comprehensive integrated electronic data capture and clinical trials management system, WebDCU™, that enables data entry from the participating clinical sites with extensive data quality control and that provides the necessary tools to efficiently manage operational activities for concurrent multiple trials, while ensuring compliance with the NINDS Common Data Elements and FDA guidance and regulations. Using the WebDCU system, we have developed, implemented and maintained a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical, biomarker and neuroimaging data. In addition, the WebDCU™ incorporates trial management information system that provides full support for all study operational activities in the StrokeNet. The neuroimaging repository at the NDMC houses protocol designated imaging that requires central review for all StrokeNet trials. In addition, in collaboration with the study Principal Investigator and other parties of the StrokeNet, the NDMC biostatisticians: contribute to the innovative and efficient protocol development (including study design and case report forms development); statistically monitor study progress; generate reports for the DSMB and the study teams; conduct interim and final analysis; disseminate study results via presentations and publications; and create public use data sets for data sharing when a study is completed.