CLINICAL CORE

临床核心

• 批准号: 7959381
• 负责人: JOAN T. MERRILL
• 金额: $ 6.41万
• 依托单位: OKLAHOMA MEDICAL RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7959381
• 关键词: Basic Science; Centers of Research Excellence; Clinic; Clinical; Clinical Data; Clinical Pharmacology; Clinical Research; Clinical Services; Clinical assessments; Computer Retrieval of Information on Scientific Projects Database; Conflict (Psychology); Data; Databases; Disease; Drug Kinetics; Enrollment; Ensure; Evaluation; Funding; Goals; Grant; Housing; Human; Informed Consent; Institution; Laboratories; Mentors; Multi-Institutional Clinical Trial; Participant; Patients; Procedures; Process; Protocols documentation; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Rheumatoid Arthritis; Sampling; Science; Secure; Social Welfare; Source; Systemic Lupus Erythematosus; United States National Institutes of Health; clinical practice; cohort; experience; human subject; instrument; meetings; programs; web based interface

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 具体目的：临床核心将为该应用程序的项目提供人类样本和经验丰富的临床团队进行的患者评估。我们将利用我们的积极的全身性红斑狼疮（SLE）和类风湿关节炎（RA）患者（RA）患者以及2003年NIH资助建造的独特的转化基础设施，以在该同盟中以适度的筹资水平为适当的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严格的良好临床实践标准 b。），包括完成知情同意书，监管报告，对临床研究参与者福利的监督以及使用经过验证的疾病活动工具提供专家临床评估。 为了确保及时，由捐助者的可用性驱动的人类生物样品的驱动驱动和存储，而不是基础研究实验室的需求相互矛盾。 c。）临床药理学计划的主要资产，该计划容纳临床核心是一家设备齐全的实验室，拥有经验丰富的技术人员，位于诊所的台阶中，具有大量的往绩记录处理生物学材料，用于精致的药物生物学和药代动力学研究，并用作临床临床研究中心实验室。 为将临床数据集成到基础研究项目中的支持​​提供支持。在这些项目中入选的患者的广泛临床，人口统计学，疾病活动和疾病损害数据将记录到现有数据库中，适当的研究人员可以通过基于网络的安全，基于网络的界面轻松检索特定于项目的特定于项目的数据库。