Data Coordinating Center for the Pediatric Heart Network

儿科心脏网络数据协调中心

基本信息

批准号：
9973166
负责人：
Julie Elaine Miller
金额：
$ 439.18万
依托单位：
NEW ENGLAND RESEARCH INSTITUTES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9973166
关键词：
Advocacy Agreement Biometry Budgets Caring Childhood Clinical Research Clinical Trials Data Monitoring Committees Collaborations Communication Conflict of Interest Data Data Analyses Data Coordinating Center Data Files Data Reporting Data Set Development Enrollment Ensure Ethics European Evidence based treatment Expenditure Family Funding Good Clinical Practice Health Health Policy Heart Information Dissemination Information Systems Infrastructure Institutional Review Boards Investigational New Drug Application Leadership Logistics Maintenance Medicine Methodology Mission Monitor National Heart, Lung, and Blood Institute Network Infrastructure New England Outcome Patients Periodicity Pharmaceutical Preparations Protocols documentation Publications Quality Control Reporting Request for Proposals Research Research Design Research Institute Research Personnel Research Support Resources Role Running Safety Sample Size Scientist Services Site Site Visit System Technology TimeLine Training Travel United States Food and Drug Administration United States National Institutes of Health Update Writing clinical center congenital heart disorder data acquisition data management data quality electronic data capture system experience improved innovation investigator training meetings member novel operation payment protocol development quality assurance recruit remote monitoring statistics symposium tool web site webinar

项目摘要

PROJECT SUMMARY/ABSTRACT New England Research Institutes, Inc. (NERI) is applying to continue its 15-year role as the Data Coordinating Center (DCC) for the Pediatric Heart Network (PHN). The PHN is a cooperative network of Core and Auxiliary Clinical Centers, a DCC, and National Heart, Lung and Blood Institute (NHLBI) Project Scientists. The objectives of the PHN DCC are to 1) manage study development, launch, and dissemination of results; 2) manage core PHN operations; and 3) coordinate logistics and other support services. As the DCC, NERI will provide robust scientific oversight and proven logistical support for the next cycle of the Network, with key responsibilities and functions for leadership in project management of the Network, overall study coordination and efficient management of data acquisition; leadership in development and deployment of innovative infrastructure and tools; electronic information and data systems; logistical and support services; novel study design and statistical methodologies; and management and distribution of Network funds. Our proposed approach presents a strong experienced NERI team, which builds upon decades of successful close collaboration with NHLBI, and ensures efficient scientific and administrative support to the PHN, using 21st century technologies. A multiple PI leadership plan is proposed to continue the leadership roles shared by Ms. Miller (Network Operations) and Dr. Stark (Statistics), with clearly delineated roles and responsibilities for leading and directing the DCC.

项目概要/摘要新英格兰研究机构 (NERI) 正在申请继续其作为数据中心 15 年的角色儿科心脏网络 (PHN) 协调中心 (DCC)。 PHN是Core的合作网络和辅助临床中心、DCC 和国家心肺和血液研究所 (NHLBI) 项目科学家。 PHN DCC 的目标是 1) 管理研究开发、启动和结果传播； 2）管理核心 PHN 运营； 3) 协调物流和其他支持服务。作为 DCC，NERI 将为网络的下一个周期提供强有力的科学监督和经过验证的后勤支持，其中关键领导网络项目管理、整体研究协调的职责和职能数据采集的有效管理；开发和部署创新的领导力基础设施和工具；电子信息和数据系统；后勤和支持服务；小说研究设计和统计方法；网络资金的管理和分配。我们提出的 NERI 团队拥有一支经验丰富、经验丰富的团队，该团队建立在数十年成功关闭经验的基础上与 NHLBI 合作，利用 21st 技术确保为 PHN 提供高效的科学和行政支持世纪科技。提出了多项 PI 领导计划，以继续由 Miller 女士（网络运营）和斯塔克博士（统计），明确划分领导和指导的角色和职责 DCC。