Clinical and Data Management Core

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SUMMARY (CORE C) The Clinical and Data Management Core (Core C) will be instrumental in 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, the Core will coordinate the compilation of clinical data and the distribution of samples available from the P01 Program dengue studies in Nicaragua and Takeda vaccine trial sites. 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 select 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 dedicated data manager at UC Berkeley 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. Third, the Core will design and maintain a web-based database system for the entry and management of immunological data generated through the Projects 1-3 and Core B. P01 investigators will be able to upload data to and download data from the database, facilitating the flow of information across all P01 Program partners. Finally, the Core will provide statistical expertise to the individual projects and use advanced statistical methods to integrate data from all Projects. Basic as well as advanced modeling methods will be used to examine relationships between immune response, covariates, and outcomes. This will include a dedicated study statistician as well as support from both the Core Leader and biostatistics consultants. 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. Aim 3 is to create and manage a database system for immunological data generated through the P01 Projects and Cores using state-of-the-art, open source, web-based information systems for data collection and sharing. Aim 4 is to provide statistical support to the Projects and integrate results from all Projects into statistical models. 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.