CLINICAL CORE

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 具体目标：临床核心将为本申请项目提供由经验丰富的临床团队进行的人体样本和患者评价。我们将利用我们的系统性红斑狼疮（SLE）和类风湿性关节炎（RA）患者的活跃队列，以及2003年由NIH资助建立的独特的翻译基础设施，以适度的资金水平为COBRE中的适当应用提供中心临床服务。目标是： a.）确保人类受试者招募、临床评估和样本捐赠程序符合药物临床试验质量管理规范的严格标准 B.）包括完成知情同意、监管报告、监督临床研究参与者的福利，以及使用经验证的疾病活动工具提供专家临床评估。 确保及时、按方案处理和储存人体生物样本，这是由捐献者的可用性驱动的，而不是由基础研究实验室的相互冲突的需求驱动的。 c.）临床药理学项目的一个主要资产是一个设备齐全的实验室，配备有经验丰富的技术人员，距离诊所仅几步之遥，具有处理复杂药物生物学和药代动力学研究的生物材料的重要记录，并作为多中心临床研究的中心实验室。 为临床数据融入基础研究项目提供支持。参与这些项目的患者的大量临床、人口统计学、疾病活动和疾病损害数据将记录在现有数据库中，适当的研究者可以通过安全的网络界面轻松检索项目特定的去识别数据。

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.