NHLBI Pediatric Translational Consortium Administrative Coordinating Center

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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.