Core Elements and Scientific Focus Areas Coordination Component

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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.