NHLBI Pediatric Translational Consortium Administrative Coordinating Center

NHLBI 儿科转化联盟行政协调中心

• 批准号: 8424991
• 负责人: SHARON L TENNSTEDT
• 金额: $ 875.66万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8424991
• 关键词: Address; Advisory Committees; Area; Basic Science; Bioinformatics; Cardiac; Cardiology; Cardiovascular Diseases; Case Report Form; Certification; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communication; Complex; Conduct Clinical Trials; Congenital Heart Defects; Consent Forms; Data; Data Coordinating Center; Data Quality; Databases; Development; Electronic Mail; Electronics; Environment; Fostering; Funding; Genetic; Genomics; Goals; Heart; Human; Image; Information Systems; Instruction; Laboratories; Lead; Leadership; Mails; Maintenance; Methodology; Molecular; Monitor; National Heart, Lung, and Blood Institute; Pathway interactions; Persons; Physiological; Preparation; Principal Investigator; Probability; Procedures; Process; Program Development; Protocols documentation; Qualifying; Quality Control; Recording of previous events; Relative (related person); Reporting; Research; Research Personnel; Research Support; Resources; Role; Schedule; Scientist; Services; Sum; Teleconferences; Telephone; Training; Translational Research; Translations; Work; data management; design; experience; innovation; meetings; member; payment; programs; symposium; web site

DESCRIPTION (provided by applicant): The NHLBI Translational Program in Pediatric Cardiovascular Disease will encourage and facilitate translation of results from basic science to clinical research and to provide clinic input to needs for basic research. The Program will consist of the Pediatric Cardiac Genomics Consortium and the Cardiac Development Consortium supported by the Administrative Coordinating Center (ACC). Each Consortium will function independently but will interact with each other as well as with the NHLBI Pediatric Heart Network. Key areas of ACC responsibility and function include provision of logistical and support services; management and distribution of Consortia funds to support Research Cores; and provision of electronic information and communication services. In addition, study activities in the Pediatric Cardiac Genomics Consortium will be supported by the PHN DCC, i.e. harmonization of protocols and consent forms across the Consortium, development and programming of case report forms; training and certification of Research Center staff in conduct of Consortium studies, management of clinical research data, and quality control activities. NERI is uniquely qualified to serve as the ACC for this initiative. Most relevant, NERI has served most effectively as the Pediatric Heart Network Data Coordinating Center (PHN DCC) since its inception in 2001. NERI's contributions to the PHN have been significant and varies has encompass numerous administrative accomplishments that are highly relevant to the ACC, as well as other scientific, statistical, and technical accomplishments. The proposed leadership of the ACC consists of key investigators with the same leadership roles in the PHN DCC who will bring extensive, directly related, and highly complementary administrative, research and clinical experience in pediatric cardiology. NERI has a long history of coordinating center work (31 DCCs) that has allowed for greater efficiency and sharing of approaches for administrative procedures unique to clinical research networks as well as innovative data management, development of public and administrative websites, and methodologies for designing and analyzing clinical studies and trials and complex longitudinal data. In sum, NERI's scientific environment contributes substantially to the probability of successful completion of the activities of this Translational Program in Pediatric Cardiovascular Disease, including successful alignment with the Pediatric Heart Network. RELEVANCE (See instructions): The NHLBI translational program in pediatric cardiovascular disease consists of two research consortia whose work will lead to enhanced understanding of the molecular, cellular, and physiologic mechanisms responsible for healthy development and the relative contribution of genetic influences to the formation of cardiac defects in humans. Collaboration and integration of the work of the NHLBI Pediatric Heart Network will provide the pathway for the translation of research findings from these two Consortia to the conduct of clinical trials.

描述(由申请人提供)： NHLBI儿童心血管疾病翻译计划将鼓励和促进将基础科学成果转化为临床研究成果，并为基础研究的需求提供临床投入。该计划将由儿科心脏基因组学联盟和由行政协调中心(ACC)支持的心脏开发联盟组成。每个联盟将独立运作，但将相互互动，以及与NHLBI儿科心脏网络进行互动。行政协调会的主要职责和职能领域包括提供后勤和支助服务；管理和分配用于支助研究核心的财团资金；以及提供电子信息和通信服务。此外，儿科心脏基因组学联盟的研究活动将得到PHN DCC的支持，即协调整个联盟的方案和同意书，开发和编制病例报告表，培训和认证研究中心工作人员进行联盟研究，管理临床研究数据，以及质量控制活动。NERI是唯一有资格担任这一倡议的行政协调会的人。最重要的是，NERI自2001年成立以来一直是最有效的儿科心脏网络数据协调中心(PHN DCC)。NERI对PHN的贡献是巨大的，各有不同，涵盖了与行政协调会高度相关的许多行政成就，以及其他科学、统计和技术成就。拟议的ACC领导层由在PHN DCC中具有相同领导角色的关键调查人员组成，他们将在儿科心脏病学方面带来广泛的、直接相关的和高度互补的管理、研究和临床经验。NERI在协调中心工作方面有很长的历史(31个DCC)，这使得临床研究网络特有的管理程序以及创新的数据管理、公共和行政网站的开发以及设计和分析临床研究和试验以及复杂的纵向数据的方法能够更高效和共享。总而言之，NERI的科学环境对成功完成这项儿科心血管疾病翻译计划活动的可能性有很大贡献，包括与儿科心脏网络的成功对接。相关性(参见说明)：NHLBI在儿童心血管疾病中的翻译计划由两个研究联合体组成，他们的工作将有助于加深对导致健康发育的分子、细胞和生理机制的理解，以及遗传影响对人类心脏缺陷形成的相对贡献。NHLBI儿科心脏网络工作的协作和整合将为将这两个联盟的研究成果转化为临床试验提供途径。