CORE--CLINICAL FACILITY

核心——临床设施

• 批准号: 7551720
• 负责人: ELAINE TIERNEY
• 金额: $ 26.28万
• 依托单位: HUGO W. MOSER RES INST KENNEDY KRIEGER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7551720
• 关键词: autism; biomedical facility; children; clinical research; cooperative study; data management; human subject; medical outreach /case finding; mental disorder diagnosis; patient /disease registry

The Clinical Core will provide a common mechanism through which study subjects are characterized, and subject and family information (including biologic samples) is collected. Centralizing and coordinating these activities in the Clinical Core will create efficiencies for the planned projects and should stimulate additional collaborations between STAART autism researchers as well as, to a limited degree, researchers not funded by STAART. A shared core dataset including basic descriptive information on all potential participants in the STAART studies will be generated. In addition, the core will assist in project-specific data management and statistical analyses. Although there will be two sites for the clinical core (Kennedy Krieger Institute and Children's National Medical Center), the operations of the clinical activities complement each other and are conceptually similar. Specific objectives of this core include: 1. identifying and recruiting STAART research participants; 2. determining eligibility of participants; 3. conducting diagnostic assessments of subjects; 4. conducting inter-rater reliability trials for autism diagnostic assessments; 5. monitoring the fidelity of test administration; 6. conducting outcome data collection; 7. facilitating the collection and distribution of biological samples; 8. providing data storage and data management support.

临床核心将提供一种通用的机制，通过该机制进行研究对象，并收集了受试者和家庭信息（包括生物学样本）。将这些活动集中和协调在临床核心中将为计划的项目创造效率，并应刺激Staart自闭症研究人员以及在有限程度上之间的其他合作，而不是由Staart资助的研究人员。将生成有关Staart研究中所有潜在参与者的基本描述性信息的共享核心数据集。此外，核心将有助于特定于项目的数据管理和 统计分析。尽管临床核心将有两个站点（肯尼迪·克里格研究所和儿童国家医疗中心），但临床活动的运作相互补充，并且在概念上相似。该核心的特定目标包括： 1。识别和招募Staart研究参与者； 2。确定参与者的资格； 3。进行受试者的诊断评估； 4。进行自闭症诊断评估的评价者间可靠性试验； 5。监视测试管理的保真度； 6。进行结果数据收集； 7。促进生物样品的收集和分布； 8。提供数据存储和数据管理支持。