This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The Clinical Core will provide OMRF COBRE investigators with unique opportunities to aid their scientific programs and to help facilitate their career development by providing a centralized process for patient-oriented research training, patient/control identification, patient/control recruitment, sample processing and access to large collections of patient/control samples with associated clinical, demographic, therapeutic and disease activity measures. The OMRF COBRE Clinical Core was established two years ago based upon the expressed need of our COBRE Junior Investigators and to date, has supported over 15 investigators in various aspects of their patient-oriented research needs. The goals of the Clinical Core are: 1) Facilitate human subject recruitment, re-contact, consent and compliance. The Clinical Core ensures that human subject recruitment, clinical assessments and sample donation procedures meet rigorous standards of good clinical practice. By performing services in informed consent, regulatory reporting, oversight of the welfare of clinical study participants, and provision of expert clinical assessments using validated disease activity instruments, the Clinical Core supports and expands the research opportunities of all COBRE investigators. 2) Provide initial processing and coding of samples provided to COBRE investigators. The Clinical Core also ensures timely, protocol-driven processing, coding and storage of human biologic samples driven by the availability of the donor, rather than the conflicting demands of a basic research laboratory. 3) Support the integration of clinical data into basic research projects. Extensive clinical, demographic, disease activity and disease damage data exists on patients enrolled with systemic rheumatic diseases. In addition, detailed information from individuals at and after vaccination is also available. The Clinical Core will also help make COBRE investigators aware of various patient and control clinical information and associated samples, which may be useful for their various projects. 4) Train COBRE investigators in human subject research and patient-oriented research design. The Clinical Core will help ensure appropriate HIPPA and human subjects training of all COBRE personnel. They will also provide guidance in the design and analysis of human studies for each project. The linking of clinical data across different COBRE projects will also be facilitated.
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