Clinical Core

临床核心

• 批准号: 8712123
• 负责人: Robert Hal Scofield
• 金额: $ 30.27万
• 依托单位: OKLAHOMA MEDICAL RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8712123
• 关键词: Adherence; Biological; Biopsy; Cells; Clinical; Clinical Data; Clinical Research; Consent; DNA; Data; Databases; Enrollment; Ensure; Goals; Housing; Human; Human Subject Research; Interdisciplinary Study; Laboratories; Nature; Oklahoma; Patients; Plasma; Process; RNA; Recruitment Activity; Regulation; Reporting; Research; Research Design; Research Personnel; Resources; Salivary Glands; Sampling; Serum; Sjogren' s Syndrome; Specific qualifier value; Time; Translational Research; cohort; data management; design; human subject; repository; success

The goals of the Clinical Core are to optimize and support projects undertaken by the CORT Investigators, to enhance interdisciplinary research capabilities between laboratories, and to expedite human subjects research in a meaningful way. The Clinical Core will provide access to prospectively followed, well-characterized cohorts of Sjogren's Syndrome (SS) patients for CORT Jnvetlgators and other users. It will also provide help in finding and recruiting specified types of Sjogren's Syndrome patients and/or controls for CORT studies. Extensive clinical and demographic data on enrolled patients will be collected and recorded into an existing database. A sophisticated level of initial sample processing will also be provided (such as isolating serum, plasma, DNA, RNA, cell subsets, salivary gland biopsies, etc). By organizing and managing the large numbers of samples and extensive data that will need to be mobilized for these projects, this Core will help ensure success of the Oklahoma Sjogren's Syndrome Center of Research Translation (OSSCORT). The Clinical Core will be an integrated part of the research team, providing help with clinical study design, sample and data management and regulatory support. The specific goals of the Clinical Core include: 1. Facilitate human subject consent, recruitment and compliance. This includes consenting recruiting and obtaining samples from SS patients and controls for CORT projects, and assisting with regulatory reporting. The Clinical Core will also provide detailed clinical information as needed for each project. 2. Facilitate access to human samples and clinical data for research purposes. This goal includes serving as a central resource for CORT investigators to design human studies, and obtain appropriately collected, processed, and stored DNA, serum, cells, salivary gland biopsies, clinical and/or de-identifed data.

临床核心的目标是优化和支持 CORT 研究人员开展的项目，增强实验室之间的跨学科研究能力，并以有意义的方式加快人类受试者研究。临床核心将为 CORT 研究者和其他用户提供前瞻性随访、特征明确的干燥综合征 (SS) 患者队列。它还将为寻找和招募特定类型的干燥综合症患者和/或对照进行 CORT 研究提供帮助。将收集登记患者的广泛临床和人口统计数据并将其记录到现有数据库中。还将提供复杂水平的初始样品处理（例如分离血清、血浆、DNA、RNA、细胞亚群、唾液腺活检等）。通过组织和管理 这些项目需要调动大量样本和广泛的数据，该核心将有助于确保俄克拉荷马州干燥综合症研究翻译中心 (OSSCORT) 的成功。临床核心将成为研究团队的一个组成部分，为临床研究设计、样本和数据管理以及监管支持提供帮助。 临床核心的具体目标包括： 1. 促进受试者同意、招募和合规。这包括同意从 SS 患者和对照中招募和获取样本以用于 CORT 项目，并协助监管报告。临床核心还将根据每个项目的需要提供详细的临床信息。 2. 促进出于研究目的获取人体样本和临床数据。这一目标包括作为 CORT 研究人员设计人类研究的中心资源，并获得适当收集、处理和存储的 DNA、血清、细胞、唾液腺活检、临床和/或去识别数据。