The goals of the Clinical Core are to optimize and support projects undertaken by the CORT Investigators, to enhance interdisciplinary research capabilities between laboratories, and to expedite human subjects research in a meaningful way. The Clinical Core will provide access to prospectively followed, well-characterized cohorts of Sjogren's Syndrome (SS) patients for CORT Jnvetlgators and other users. It will also provide help in finding and recruiting specified types of Sjogren's Syndrome patients and/or controls for CORT studies. Extensive clinical and demographic data on enrolled patients will be collected and recorded into an existing database. A sophisticated level of initial sample processing will also be provided (such as isolating serum, plasma, DNA, RNA, cell subsets, salivary gland biopsies, etc). By organizing and managing the large numbers of samples and extensive data that will need to be mobilized for these projects, this Core will help ensure success of the Oklahoma Sjogren's Syndrome Center of Research Translation (OSSCORT). The Clinical Core will be an integrated part of the research team, providing help with clinical study design, sample and data management and regulatory support. The specific goals of the Clinical Core include: 1. Facilitate human subject consent, recruitment and compliance. This includes consenting recruiting and obtaining samples from SS patients and controls for CORT projects, and assisting with regulatory reporting. The Clinical Core will also provide detailed clinical information as needed for each project. 2. Facilitate access to human samples and clinical data for research purposes. This goal includes serving as a central resource for CORT investigators to design human studies, and obtain appropriately collected, processed, and stored DNA, serum, cells, salivary gland biopsies, clinical and/or de-identifed data.
The Clinical Core will house the most valuable resource available to the OSSCORT: a repository of biological samples and extensive data collected from carefully characterized patients with Sjogren's Syndrome and controls. At the same time, it will guarantee protection to human subjects and adherence to existing regulations while facilitating the interdisciplinary nature of the project
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