Stroke Trials Network National Data Management Center (NDMC)

中风试验网络国家数据管理中心 (NDMC)

基本信息

批准号：
8720182
负责人：
Yuko Y Palesch
金额：
$ 142.14万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
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/8720182
关键词：
Affect Age Biological Markers Biometry Case Report Form Cessation of life Clinical Clinical Trials Clinical Trials Design 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 Emergency treatment 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 Neurological emergencies Online Systems Patients Phase Phase III Clinical Trials Population Positioning Attribute Prevention Principal Investigator Procedures Process 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 Stroke Stroke prevention Study Subject System Therapy Clinical Trials Training Universities Work base 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 tool treatment trial web site

项目摘要

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）：中风是一种致残且常常致命的疾病，影响所有年龄段，但随着人口老龄化，中风发病率预计会在美国上升；因此，中风对公共卫生和卫生资源的影响预计会增加。中风进展审查小组和 NINDS 已确定需要一个中风临床试验中心网络，以便优先考虑并有效地设计和进行转化和探索性早期 I/II 期临床试验和大型 III 期临床试验。 NINDS 中风试验网络是一个多学科中风研究基础设施，由一个国家临床协调中心、一个国家数据管理中心 (NDMC) 和 25 个区域协调中心组成。与网络中涉及的所有各方建立协作关系，并提供高效、标准化的中央数据管理，为卒中试验的规划和执行提供高质量的数据和统计支持。南卡罗来纳医科大学 (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站点进行分布式数据输入，并进行广泛的数据质量控制，并提供必要的工具来有效地使用 WebDCU 管理多项试验的操作活动，同时确保遵守 NINDS 通用数据元素和 FDA 法规。系统，我们将开发、实施和维护一个中央数据库，以简化临床、生物标志物和神经影像数据的数据收集、处理和监测的管理并最大限度地提高效率。此外，WebDCU”将纳入试验管理信息系统。 NDMC 的神经影像核心将与研究首席研究员和中风试验网络的其他各方合作，为中风试验网络的所有研究运营活动提供全力支持。生物统计学教师将：促进创新和高效的方案开发（包括研究设计和病例报告表格开发）；为 DSMB 和研究团队生成报告；最后，作为神经急症治疗试验 (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。