Stroke Trials Network National Data Management Center (NDMC)

中风试验网络国家数据管理中心 (NDMC)

• 批准号: 9322342
• 负责人: Yuko Y Palesch
• 金额: $ 106.99万
• 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 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9322342
• 关键词: Affect; Age; Biometry; Case Report Form; Cessation of life; Clinical; Clinical Trials; Clinical Trials Network; Collaborations; Common Data Element; Communication; Conduct Clinical Trials; Data; Data Collection; Data Coordinating Center; Data Quality; Data Set; Databases; Development; Disease; Elderly; Ensure; Environment; Faculty; Goals; Health Resources; Health Sciences; Human Resources; Incidence; Individual; Information Systems; Intervention; Leadership; Management Information Systems; Medical; Methods; Monitor; National Institute of Neurological Disorders and Stroke; Network Infrastructure; Neurological emergencies; Online Systems; Patients; Phase; Phase III Clinical Trials; Population; Positioning Attribute; Prevention trial; Principal Investigator; Procedures; Progress Review Group; Protocols documentation; Public Health; Publications; Quality Control; Recovery; Recruitment Activity; Recurrence; Regulation; Reporting; Research; Research Design; Research Infrastructure; Risk; Role; Scientist; Site; Societies; South Carolina; Standardization; Stroke; Stroke prevention; Study Subject; System; Therapy Clinical Trials; Training; Universities; Work; base; clinical biomarkers; clinical research site; data management; data sharing; design; disability; distributed data; electronic data; experience; implementation trial; innovation; member; multidisciplinary; neuroimaging; operation; protocol development; public health relevance; quality assurance; repository; statistics; stroke treatment; tool; treatment trial; trial design; web site

DESCRIPTION (provided by applicant): 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 NINDS have identified a need for a network of stroke clinical trials centers in order to prioritize and efficiently design nd conduct translational and exploratory early Phase I/II clinical trials and large Phase III clinical trials to identify and advance stroke treatments. The NINDS Stroke Trials Network is a multidisciplinary stroke research infrastructure that consists of a National Clinical Coordinating Center, a National Data Management Center (NDMC), and 25 Regional Coordinating Centers. 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 en, the Data Coordination Unit (DCU) at the Medical University of South Carolina has developed a web-based comprehensive integrated data and project management system, WebDCU", that enables distributed data entry from the participating clinical sites with extensive data quality control and also provides the necessary tools to efficiently manage operational activities for multiple trials, while ensuring compliance with the NINDS Common Data Elements and FDA regulations. Using the WebDCU� system, we will develop, implement and maintain 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" will incorporate trial management information system that will provide full support for all study operational activities in the Stroke Trials Network. The Neuroimaging Core of the NDMC will create neuroimaging repository for the stroke trials. In collaboration with the study Principal Investigator and the other parties of the Stroke Trials Network, the DCU biostatistics faculty members will: 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 and dissemination of study results via presentations and publications; and create public use datasets for data sharing. Finally, as the Statistics and Data Management Center for the Neurological Emergencies Treatment Trials (NETT) Network, the DCU offers unique advantage of seamless collaboration between the NETT and Stroke Trials Networks.

描述（由申请人提供）：中风是一种致残性疾病，往往是致命的，影响所有年龄段，但主要是在老年人。随着人口老龄化，美国的卒中发病率预计将上升;因此，其对公共卫生和卫生资源利用的影响将继续显着。卒中进展审查小组和NINDS已经确定了对卒中临床试验中心网络的需求，以便优先考虑和有效地设计和实施转化和探索性早期I/II期临床试验和大型III期临床试验。 试验以确定和推进中风治疗。NINDS卒中试验网络是一个多学科卒中研究基础设施，由国家临床协调中心、国家数据管理中心（NDMC）和25个区域协调中心组成。 NDMC的职责是与网络中的所有参与方建立合作关系，并提供高效和标准化的中央数据管理，从而在卒中试验的计划和执行中产生高质量的数据和统计支持。为此，南卡罗来纳州医科大学的数据协调单位（DCU）开发了一个基于网络的综合集成数据和项目管理系统“WebDCU”，该系统能够从参与的临床研究中心进行分布式数据输入，并进行广泛的数据质量控制，还提供了必要的工具来有效管理多项试验的操作活动，同时确保符合NINDS通用数据元素和FDA法规。使用WebDCU系统，我们将开发，实施和维护一个中央数据库，简化和最大限度地提高数据收集，处理和监测临床，生物标志物和神经影像数据的管理效率。此外，WebDCU”将纳入试验管理信息系统，为卒中试验网络中的所有研究操作活动提供全面支持。NDMC的神经影像核心将为卒中试验创建神经影像库。与研究主要研究者和卒中试验网络的其他各方合作，DCU生物统计学教员将：（包括研究设计和病例报告表开发）;统计监测研究进展;为DSMB和研究团队生成报告;进行中期和最终分析，并通过介绍和出版物传播研究结果;创建供公众使用的数据集，以供数据共享。最后，作为神经系统紧急情况治疗试验（NETT）网络的统计和数据管理中心，DCU提供了NETT和中风试验网络之间无缝协作的独特优势。