NIH StrokeNet National Data Management Center (NDMC)

NIH StrokeNet 国家数据管理中心 (NDMC)

• 批准号: 9574341
• 负责人: Yuko Y Palesch
• 金额: $ 110.19万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9574341
• 关键词: Acute; Address; Affect; Age; American Heart Association; American Stroke Association; Applications Grants; Award; Case Report Form; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Common Data Element; Conduct Clinical Trials; Data; Data Collection; Data Quality; Data Set; Databases; Development; Devices; Disease; Elderly; Emergency Care; Enrollment; Ensure; Funding; Goals; Grant; Guidelines; Health Resources; Image; Individual; Industry; Information Management; International; Intervention; Leadership; Management Information Systems; Medical; Methods; Mission; Monitor; National Institute of Neurological Disorders and Stroke; Network Infrastructure; Neurosciences; Online Systems; Patients; Peer Review; Pharmacologic Substance; Phase II Clinical Trials; Phase III Clinical Trials; Population; Prevention; Principal Investigator; Process; Progress Review Group; Protocols documentation; Public Health; Publications; Quality Control; Recovery; Recurrence; Registries; Regulation; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Risk; Role; Scientist; Societies; South Carolina; Standardization; Stroke; Stroke prevention; StrokeNet clinical trials; StrokeNet trials; Study Subject; System; Testing; Therapy Clinical Trials; Time; TimeLine; United States National Institutes of Health; Universities; Work; base; clinical biomarkers; clinical implementation; clinical research site; data management; data sharing; design; electronic data; improved; innovation; multidisciplinary; neuroimaging; novel therapeutics; protocol development; recruit; repository; stroke clinical trials; stroke incidence; stroke rehabilitation; stroke treatment; stroke trials; tool; treatment effect; trial design

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.

中风是一种致残且常常致命的疾病，影响所有年龄段，但主要是老年人。中风发生率 随着人口老龄化，美国的这一数字预计将会上升。因此，它对公共卫生和卫生资源的影响 利用率将继续显着。中风进展审查小组和国家卒中研究所 神经疾病和中风 (NINDS) 已确定需要建立中风临床试验中心网络 为了优先考虑并有效地设计和进行探索性（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、国家数据管理中心 中心 (NDMC)、25 个区域协调中心和 NINDS。其使命是开发和测试新的 中风治疗、恢复和预防的疗法可以减轻中风的全球负担。 NDMC 的作用是与网络中涉及的所有各方建立协作关系， 提供高效、标准化的中央数据管理，产生高质量的数据和统计支持 中风试验的规划和执行。为此，医疗中心的数据协调单位（DCU） 南卡罗来纳大学开发了一种基于网络的综合集成电子数据采集和 临床试验管理系统 WebDCU™，可以通过以下方式从参与的临床中心输入数据： 广泛的数据质量控制，并提供有效管理运营活动所需的工具 用于并行多项试验，同时确保符合 NINDS 通用数据元素和 FDA 指导和法规。使用WebDCU系统，我们开发、实施和维护了一个 中央数据库，简化数据收集、处理、管理的管理并最大限度地提高效率 以及临床、生物标志物和神经影像数据的监测。此外，WebDCU™ 还包含试用版 管理信息系统，为 StrokeNet 中的所有研究运营活动提供全面支持。 NDMC 的神经影像存储库包含协议指定的影像，需要中央审查 所有 StrokeNet 试验。此外，与该研究的首席研究员和其他各方合作 StrokeNet，NDMC 生物统计学家：为创新和高效的协议开发做出贡献（包括 研究设计和病例报告表格开发）；统计监测研究进展；生成报告 DSMB 和研究团队；进行中期和最终分析；通过演示传播研究结果 出版物；并在研究完成后创建公共使用数据集以进行数据共享。