Clinical Core

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SUMMARY/ABSTRACT The Clinical Core will be responsible for patient recruitment, sample acquisition, clinical data collection, and regulatory compliance for both of the research projects in the HIPC Center entitled “Systems immunology profiling of respiratory viral infections in vulnerable populations”. The Clinical Core has three Specific Aims. In Specific Aim 1, the Clinical Core will identify, recruit, and follow a pediatric cohort with asthma and an adult cohort with rheumatoid arthritis before and after acute respiratory viral infection. In Specific Aim 2, the Clinical Core will manage the acquisition, processing, and distribution of biologic specimens with associated clinical information. In Specific Aim 3, the Clinical Core will ensure regulatory compliance and the protection of human subjects. To accomplish these aims, the Clinical Core will leverage the existing infrastructure of the Childhood Asthma in Urban Settings (CAUSE) Network and the Benaroya Research Institute at Virginia Mason (BRI). For Research Project 1, the Clinical Core will recruit children with asthma, children with allergic sensitization, and healthy children with no personal history of asthma or allergic sensitizations. For Research Project 2, the Clinical Core will recruit adults with rheumatoid arthritis and healthy adults with no personal or family history of autoimmune disease. The Clinical Core will also be responsible for longitudinal sampling of peripheral blood, nasal swabs, and sputum collected at four in-patient clinic visits: baseline, during acute respiratory viral infection (ARVI; 4-6 days post start of ARVI), 4 weeks post ARVI, and 12 months post baseline. Nasal swabs will also be collected at home at the start and end of ARVI. The Clinical Core will also collect demographic and clinical data using the HIPC clinical characterization template. Samples and linked clinical data will be tracked in the BRI Sample Repository database where datasets can easily be queried for sample selection and provided to research scientists for samples upon unblinding, or to the Data Management & Analysis Core for bioinformatics analysis. The Clinical Core will also be responsible for sample processing as well as sample distribution to each of the Research Projects, the Genomics Core, and the Adaptive Phenotyping Core. The Clinical Core will ensure regulatory compliance and the protection of human subjects by developing and managing registry and study documents including clinical protocols, IRB applications, and informed consent forms. Thus, the Clinical Core has an essential role in ensuring the HIPC Center achieves its scientific objectives.