CLINICAL CORE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标：临床核心将为该应用程序的项目提供由经验丰富的临床团队执行的人体样本和患者评估。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这一Cobre的适当应用提供中央临床服务。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良好临床实践的严格标准 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，以及使用经过验证的疾病活动工具提供专家临床评估。 确保由捐赠者的可获得性而不是基础研究实验室相互冲突的需求驱动的对人体生物样本的及时、协议驱动的处理和存储。 C.)临床核心所在的临床药理学计划的一项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，位于距离临床几步远的地方，拥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。参加这些项目的患者的大量临床、人口、疾病活动和疾病损害数据将被记录到一个现有的数据库中，适当的调查人员可以通过一个安全的、基于网络的界面从该数据库中轻松检索特定于项目的、未查明身份的数据。

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.