CORE C: Clinical and Data Management

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CORE C: Clinical and Data Management Core (UC Berkeley, University of Michigan, Sustainable Sciences Institute) SUMMARY The Clinical and Data Management Core (Core C) will be instrumental for the success of the P01 Program. First, the Core will continue to conduct the Pediatric Dengue Cohort Study in Managua, Nicaragua. This cohort study is the longest continuous cohort study of dengue and as such is an invaluable source of samples and clinical data from children with natural repeat dengue virus (DENV) infections. Both retrospectively and prospectively collected samples and data will be available to the P01 Projects. Core C will oversee all aspects of running the Cohort Study including enrollment, sample collection and storage, data collection and management, quality control, provision of medical care, and human subjects documentation. Second, Core C will coordinate the compilation of clinical data and the distribution of samples available from the P01 Program dengue studies in Nicaragua and the Philippines, where a cohort study of children vaccinated with the Dengvaxia® dengue vaccine is ongoing. To this end, the Core will design, maintain, update and oversee the P01 Program databases, which will include clinical data, sample characteristics and availability. Core C will provide tailored data sets and assist in selection of analysis-specific biological specimens, ensuring efficient data sharing and sample distribution through the implementation of high levels of quality control. This will include having a data manager at the University of Michigan (UM) who will compile the data from the clinical sites and use it to assemble data sets, including the creation of any necessary variables for P01 Program sites. Core C personnel at UC Berkeley will be responsible for receiving samples from Nicaragua, maintaining an inventory, and distributing the samples to P01 Projects in response to requests and in coordination with the data manager at UM. Third, the Core will maintain a copy of immunological data generated through the Projects 1-3 and Core B and will deposit data into ImmPort. P01 investigators will be able to submit data for upload to and download data from the database, facilitating the flow of information across all P01 Program partners. Aim 1 is to continue conducting the community-based prospective Pediatric Dengue Cohort Study in Managua, Nicaragua. Aim 2 is to coordinate clinical data compilation, integration and distribution, and shipment of clinical samples, and to perform phylogenetic sequencing. Aim 3 is to manage data generated through the P01 and to deposit immunological data generated through the P01 Projects and Cores into ImmPort. Taken together, the Clinical and Data Management Core will play an essential role in the P01 Program by providing data and samples to scientific Projects for the ultimate purpose of identifying both natural and vaccine-induced immune correlates of protection against dengue disease.