Pediatric Heart Network: Data Coordinating Center

此应用程序将新英格兰研究所(NERI)的角色描述为建议的数据 儿童心脏病临床研究网络(PHN)延续协调中心。这个 PHN的具体目标是高效地进行多中心临床研究(包括但不限于 随机临床试验)，并评估新的和现有的治疗和管理方法 患有结构性先天性心脏病、炎症性心脏病、心肌病和 心律不齐。NERI自PHN成立以来一直担任PHN数据协调中心，并 为网络的科学成就做出了贡献，并制定和实施了 该网络实施的行政、数据管理、统计和技术程序， 目前包括7个临床中心和7个辅助中心。作为PHN DCC，NERI将继续 协调所有公共卫生网络委员会的活动，维护和加强安全的网络和公共网站， 为研究设计和数据分析(包括临床、替代和成本)提供统计专业知识 结果)，监测患者安全，监督监管要求，并提交监管/安全报告 视需要而定。NERI还将增强其专有的基于Web的数据管理系统Adet (高级数据输入和协议跟踪)，为适应新的研究，执行以下程序 选择和实施多个核心实验室进行网络学习，实践高质量 通过对诊所工作人员的集中培训、现场访问和专门的实验室规程，确保技术。在 在续约期内，NERI还将利用其现有的基础设施，因为它拥有几个NIH网络的经验 管理临床中心的病人护理资金，并传播PHN研究成果。奈里会的 在作为PHN DCC的现有系统的基础上构建并利用其经验丰富的管理数据 管理和规划、统计和临床/监管团队完成3项正在进行的PHN研究 并在新的资助期内启动至少3项新的研究。 儿科心脏病临床研究网络将对该领域的进展产生直接影响 通过提供资源，以多中心的方式进行研究，从而促进儿科心脏病学的发展 提供足够的患者来评估有关管理和治疗的重要假设 并迅速将这些发现传播到儿科和心脏病界。

This application describes the role of New England Research Institutes (NERI) as the proposed Data oordinating Center for continuation of the Pediatric Heart Disease Clinical Research Network (PHN). The specific aim of the PHN is to efficiently conduct multi-center clinical studies (including but not limited to randomized clinical trials), and to evaluate new and existing treatments and management approaches for children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, and arrhythmias. NERI has served as the PHN Data Coordinating Center since the inception of the PHN and has contributed to the scientific accomplishments of the network as well as developed and implemented administrative, data management statistical, and technical processes for the conduct of this network, which currently includes 7 clinical centers and 7 auxiliary centers. As the PHN DCC, NERI will continue to coordinate the activities of all PHN committees, maintain and enhance secure network and public websites, provide statistical expertise for study design and data analysis (including clinical, surrogate, and cost outcomes), monitor patient safety and oversee regulatory requirements and submit regulatory/safety reports as needed. NERI will also enhance the its proprietary Web-based data management system, ADEPT (Advanced Data Entry and Protocol Tracking), to accommodate new studies, execute procedures for the selection and implementation of multiple core laboratories for network studies, and practice good quality assurance technique via central training of clinic staff, site visits, and specialized laboratory protocols. In the renewal period, NERI will also utilize its existing infrastructure due its experience with several NIH networks to administer patient care funds to clinical centers and disseminate the results of PHN research. NERI will build upon the systems already in place as the PHN DCC and utilize its experienced Administrative, Data Management & Programming, Statistical, and Clinical/Regulatory Teams to complete 3 ongoing PHN studies and initiate at least 3 new studies in the new grant period. The Pediatric Heart Disease Clinical Research Network will have a direct impact on advances in the field of pediatric cardiology by providing the resources to conduct studies in a multi-center fashion, which will provide sufficient patients to evaluate important hypotheses regarding management and therapy in this patient population and prompt dissemination of these findings to the pediatric and cardiology communities.