NHLBI Pediatric Translational Consortium Administrative Coordinating Center

描述（由申请人提供）： NHLBI儿科心血管疾病转化项目将鼓励和促进基础科学成果向临床研究的转化，并为基础研究的需求提供临床投入。该计划将由行政协调中心（ACC）支持的儿科心脏基因组学联盟和心脏发育联盟组成。每个联盟将独立运作，但将相互作用，以及与NHLBI儿科心脏网络。行政协调会责任和职能的关键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联合会资金;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，即联盟内方案和知情同意书的协调、病例报告表的开发和编程、研究中心工作人员开展联盟研究的培训和认证、临床研究数据管理和质量控制活动。NERI是唯一有资格担任这一倡议的行政协调会。最重要的是，NERI自2001年成立以来一直是儿科心脏网络数据协调中心（PHN DCC）。NERI对PHN的贡献是显著的，包括许多与ACC高度相关的行政成就，以及其他科学，统计和技术成就。ACC的拟议领导层由在PHN DCC中具有相同领导角色的关键研究者组成，他们将带来儿科心脏病学方面广泛、直接相关和高度互补的行政、研究和临床经验。NERI在协调中心工作（31个DCC）方面有着悠久的历史，可以提高效率，共享临床研究网络特有的行政程序方法，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纵向数据的方法。总之，NERI的科学环境大大有助于成功完成儿科心血管疾病转化计划活动的可能性，包括与儿科心脏网络的成功对齐。相关性（参见说明）：儿科心血管疾病的NHLBI翻译计划由两个研究财团组成，其工作将导致对健康发育的分子，细胞和生理机制以及遗传影响对人类心脏缺陷形成的相对贡献的进一步了解。NHLBI儿科心脏网络工作的合作和整合将为这两个联盟的研究结果转化为临床试验提供途径。

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.