Core Elements and Scientific Focus Areas Coordination Component

迫切需要精心设计的研究来检验环境暴露对健康的影响 对儿童的影响。为了解决这些知识差距，环境对儿童健康的影响 结果(ECHO)计划承诺利用现有的儿科队列来测试新的假设 环境暴露影响儿科健康。杜克临床研究所(DCRI)建议 作为ECHO协调中心(ECHO CC)，为 管理、指导和全面协调所有共同的回声活动。DCRI独一无二地准备好 领导这一雄心勃勃的计划。作为世界上最大的学术研究机构，DCRI管理着近30个 积极的网络和行政协调中心的资助，并已成为儿科临床的领导者 研究。以促进针对科学假设量身定做的创新、严格的研究方案； 在儿科队列网络中实施方案；并提供研究支持，以确保高 高质量的研究操作并及时完成，DCRI将建立ECHO CC核心要素 和科学重点领域协调部分(SFA部分)。ECHO SFA组件将 领导回声范围和科学重点领域协议的开发和实施。这将是 由DCRI在1)儿科方案开发；2)数据协调；3)站点方面的丰富经验推动 培训；以及4)与范德比尔特大学合作，支持IRB的中央职能。为了实现这一愿景， SFA构成部分将设立三个小组，开发和实施创新研究 ECHO计划：1)研究设计团队将开发、审查和批准所有ECHO范围的和科学的 重点领域协议；2)研究启动小组将促进CIRB进程，监督现场培训，以及 与ECHO数据分析中心、生物库和CHEAR核心合作开展研究 样本收集、存储和测试的文件和计划；以及3)研究指导小组将 负责确保所有研究成果在预算范围内按时完成。

Well-designed research is urgently needed to examine the impact of environmental exposures on health outcomes in children. To address these knowledge gaps, the Environmental Influences on Child Health Outcomes (ECHO) program promises to leverage extant pediatric cohorts to test new hypotheses of how environmental exposures impact pediatric health. The Duke Clinical Research Institute (DCRI) proposes to serve as the ECHO Coordinating Center (ECHO CC) to provide the organizational framework for the management, direction, and overall coordination of all common ECHO activities. DCRI is uniquely poised to lead this ambitious initiative. As the world’s largest academic research organization, DCRI manages nearly 30 active network and administrative coordinating center grants and has emerged as a leader in pediatric clinical research. In order to facilitate innovative, rigorous study protocols tailored to the scientific hypotheses; implement protocols across a network of pediatric cohorts; and provide study support to ensure high quality study operations and timely completion, the DCRI will establish the ECHO CC Core Elements and Scientific Focus Area Coordination Component (SFA Component). The ECHO SFA Component will lead the development and implementation of ECHO-wide and Scientific Focus Area protocols. This will be facilitated by DCRI’s extensive experience in 1) pediatric protocol development; 2) data harmonization; 3) site training; and 4) collaborating with Vanderbilt University to support central IRB functions. To achieve this vision, the SFA Component will establish three Teams that will develop and implement innovative studies for the ECHO Program: 1) The Study Design Team will develop, review, and approve all ECHO-wide and scientific focus area protocols; 2) The Study Start-up Team will facilitate the cIRB process, oversee site training, and work alongside the ECHO Data Analysis Center, Biorepository, and CHEAR Cores to develop study documents and plan for sample collection, storage, and testing; and 3) The Study Conduct Team will be responsible for ensuring all study deliverables are completed on time and within the budget.