Core Elements and Scientific Focus Areas Coordination Component

核心要素和科学重点领域协调部分

• 批准号: 10015362
• 负责人: Phillip Brian Smith
• 金额: $ 896.55万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10015362
• 关键词: Address; Air Pollution; Area; Biological; Budgets; Child; Child Health; Childhood; Climate; Clinical Research; Collaborations; Data Analyses; Development; Doctor of Philosophy; Elements; Ensure; Environmental Exposure; Environmental Impact; Goals; Grant; Health; Institutional Review Boards; International; Intervention; Knowledge; Lead; National Institute of Child Health and Human Development; Outcome; Pediatric cohort; Process; Protocols documentation; Research; Research Design; Research Institute; Site; Testing; Time; Training; Universities; Vision; Work; biobank; data harmonization; experience; exposed human population; innovation; novel marker; operation; programs; protocol development; sample collection

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.

迫切需要精心设计的研究来检查环境暴露对健康的影响 儿童的成果。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 环境暴露影响儿童健康。杜克临床研究所（DCRI）建议， 作为ECHO协调中心（ECHO CC），为 管理、指导和全面协调欧共体人道处的所有共同活动。DCRI是独一无二的， 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赠款，并已成为儿科临床的领导者 research.为了促进创新，严格的研究协议量身定制的科学假设; 在儿科队列网络中实施方案;并提供研究支持，以确保 质量研究操作和及时完成，DCRI将建立ECHO CC核心要素 科学重点领域协调部分（SFA部分）。欧洲共同体人道处SFA部分将 领导ECHO范围内和科学重点领域协议的制定和实施。这将是 DCRI在1）儿科方案制定; 2）数据协调; 3）研究中心 培训;以及4）与范德比尔特大学合作，支持中心IRB职能。为了实现这一愿景， 国家林业局将成立三个小组，负责开发和实施创新研究， ECHO计划：1）研究设计团队将制定、审查和批准所有ECHO范围内的科学计划， 重点领域方案; 2）研究启动团队将促进cIRB流程，监督研究中心培训，以及 与ECHO数据分析中心、生物储存库和CHEMICAL核心一起开展研究 样本采集、储存和检测的文件和计划;以及3）研究实施团队将 负责确保所有研究可交付成果在预算范围内按时完成。