Oversight and Project Management Component

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OVERSIGHT AND PROJECT MANAGEMENT COMPONENT ABSTRACT 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 and new 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 >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 Oversight and Project Management Component. The specific aims of the Oversight and Project Management Component, led by Drs. Brian Smith and Linda Adair, are to 1) oversee development and implementation of a standardized ECHO Cohort Protocol 2) monitor progress of the ECHO Cohort and individual Cohort Study Sites; and 3) coordinate diversity, equity, inclusion, and accessibility activities across the ECHO Program. The Oversight and Project Management Component will include two teams: the Study Development and Implementation Team and the Site Activation and Progress Team. The Study Development and Implementation Team will be responsible for facilitating the refinement, review, and monitoring of the ECHO Cohort Protocol, specifically incorporating the new preconception section and any subsequent protocol amendments. The Site Activation and Progress Team will be responsible for ECHO Cohort Study Site partnerships; site management and monitoring; and central IRB support.