Pediatric Heart network DCC

儿科心脏网络 DCC

• 批准号: 8862520
• 负责人: Julie Elaine Miller
• 金额: $ 905.41万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-06 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8862520
• 关键词: Adolescent and Young Adult; Arrhythmia; Bioinformatics; Books; Budgets; Cardiology; Cardiovascular system; Case Report Form; Certification; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Code; Collaborations; Communication; Congenital Heart Defects; Contracts; Core Facility; Data; Data Coordinating Center; Data Quality; Data Set; Databases; Development; Diagnostic; Electronics; Event; Funding; Health; Heart; Heart Abnormalities; Heart Diseases; Image; Inflammatory; Information Systems; Journals; Laboratories; Leadership; Maintenance; Manuals; Manuscripts; Measurement; Medical; Medical center; Mission; Monitor; Myocardium; Myopathy; National Heart, Lung, and Blood Institute; New England; Occupational activity of managing finances; Online Systems; Operative Surgical Procedures; Pediatric cardiology; Performance; Persons; Pharmaceutical Preparations; Policies; Positioning Attribute; Preparation; Principal Investigator; Procedures; Process; Program Development; Publications; Quality Control; Quality of life; Reading; Reporting; Research; Research Design; Research Infrastructure; Research Institute; Research Personnel; Research Support; Resources; Role; Safety; Sample Size; Schedule; Science; Scientist; Services; Site; System; Teleconferences; Testing; Training; Translational Research; Writing; biobank; clinical research site; data acquisition; design; distributed data; improved; meetings; operation; payment; programs; protocol development; statistics; symposium; tool; web site

DESCRIPTION (provided by applicant): New England Research Institutes, Inc. (NERI) is applying to continue its 10-year role as the Data Coordinating Center (DCC) for the Pediatric Heart Network (PHN). The PHN will continue as a cooperative network of up to 8 Clinical Centers, 15 auxiliary sites, a DCC, a Network Chair, and NHLBI Project Scientists. The objectives of the PHN are to 1) provide an infrastructure for multi-center collaborative clinical research, and 2) to evaluate diagnostic, medical, interventional, and surgical therapies for congenital heart defects, inflammatory heart disease, heart muscle disease, and arrhythmias. As the DCC, NERI will continue to provide scientific and logistical support for the next cycle of the Network, with key responsibilities and functions for leadership in study design and statistics, overall study coordination and management of data acquisition; leadership in development activities for bioinformatics infrastructure and tools; electronic information and data systems; logistical and support services; and management and distribution of Network funds. A multiple PI leadership plan is proposed to continue the leadership roles shared by Dr. Sleeper (Clinical and Statistical Science) and Dr. Tennstedt (Network Operations), with clearly delineated roles and responsibilities for leading and directing the DCC, intellectually and operationally. Importantly, the DCC staff will be organized to include a Network Manager who is also the Manager for the NHLBI Bench to Bassinet Program. This will position the DCC to facilitate integration of the PHN as the clinical trials component of the B2B Program.

描述(由申请人提供)： 新英格兰研究所(NERI)正在申请继续其作为儿科心脏网络(PHN)数据协调中心(DCC)的10年角色。PHN将继续作为一个合作网络，由多达8个临床中心、15个辅助站点、一个DCC、一个网络教席和NHLBI项目科学家组成。PHN的目标是1)为多中心协作临床研究提供基础设施，2)评估先天性心脏病、炎症性心脏病、心肌疾病和心律失常的诊断、医学、介入和手术治疗。作为生物信息学中心，NERI将继续为网络的下一个周期提供科学和后勤支助，其主要职责和职能是领导研究设计和统计、总体研究协调和数据获取管理；领导生物信息学基础设施和工具的开发活动；电子信息和数据系统；后勤和支助服务；以及网络资金的管理和分配。提出了一个多PI领导计划，以继续Sleeper博士(临床和统计科学)和Tennstedt博士(网络运营)共享的领导角色，明确界定在智力和业务上领导和指导DCC的角色和责任。重要的是，DCC的工作人员将包括一名网络经理，他也是NHLBI板凳到摇篮计划的经理。这将定位DCC，以促进PHN作为B2B计划的临床试验组成部分的整合。