CLINICAL CORE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Specific Aims: The Clinical Core will provide the projects of this application with human samples and patient evaluations performed by an experienced clinical team. We will make use of our active cohorts of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients and a unique translational infrastructure that was built with NIH funding in 2003 to provide central clinical services for appropriate applications in this COBRE at a modest funding level. The goals are: a.) to ensure that human subject recruitment, clinical assessments and sample donation procedures meet rigorous standards of good clinical practice b.) , including completion of informed consent, regulatory reporting, oversight of the welfare of clinical study participants, and provision of expert clinical assessments using validated disease activity instruments. to ensure timely, protocol-driven processing and storage of human biologic samples driven by the availability of the donor, rather than the conflicting demands of a basic research laboratory. c.) A major asset of the Clinical Pharmacology Program which houses the Clinical Core is a fully equipped laboratory staffed with experienced technicians, located steps from the clinic, with a significant track record processing biologic materials for sophisticated pharmaco-biologic and pharmacokinetic studies, and serving as a Central laboratory for multi-center clinical studies. to provide support for integration of clinical data into basic research projects. Extensive clinical, demographic, disease activity and disease damage data on patients enrolled in these projects will be recorded into an existing database, from which project-specific, de-identified data can be easily retrieved by the appropriate investigators through a secure, web-based interface.