Clinical Core

摘要/摘要 临床核心将负责患者招募、样本获取、临床数据收集和 重债穷国中心题为“系统免疫学”的两个研究项目的合规情况 脆弱人群中呼吸道病毒感染的概况“。临床核心有三个具体目标。在……里面 具体目标1，临床核心将识别、招募和跟踪哮喘儿童队列和一名成年人 急性呼吸道病毒感染前后类风湿性关节炎的队列。在具体目标2中，临床 CORE将管理生物标本的获取、处理和分发，以及与临床相关的 信息。在具体目标3中，临床核心将确保遵守法规并保护人类 研究对象。为了实现这些目标，临床核心将利用现有的儿童基础设施 城市环境中的哮喘(原因)网络和弗吉尼亚州梅森的贝纳罗亚研究所(BRI)。为 研究项目1，临床核心将招募哮喘儿童、过敏儿童和 无哮喘或过敏性过敏史的健康儿童。对于研究项目2， 临床核心将招募患有类风湿性关节炎的成年人和没有个人或家族病史的健康成年人。 自身免疫性疾病。临床核心还将负责外周血液的纵向采样， 4次住院就诊时采集的鼻拭子和痰：基线，急性呼吸道病毒期间 感染(ARVI；ARVI开始后4-6天)、ARVI后4周和基线后12个月。鼻拭子 也将在阿维开始和结束时在家里收集。临床核心中心还将收集人口统计和 使用HIPC临床特征模板的临床数据。将跟踪样本和相关联的临床数据 在BRI样本存储库数据库中，可以轻松查询数据集以进行样本选择和 提供给研究科学家以获取解盲后的样本，或提供给数据管理和分析核心 生物信息学分析。临床核心还将负责样本处理以及样本 分发到每个研究项目、基因组核心和适应性表型核心。这个 临床核心将确保法规遵从性和保护人类受试者通过开发和 管理注册和研究文档，包括临床方案、IRB应用和知情同意 表格。因此，临床核心在确保HIPC中心实现其科学性方面具有至关重要的作用 目标。

SUMMARY/ABSTRACT The Clinical Core will be responsible for patient recruitment, sample acquisition, clinical data collection, and regulatory compliance for both of the research projects in the HIPC Center entitled “Systems immunology profiling of respiratory viral infections in vulnerable populations”. The Clinical Core has three Specific Aims. In Specific Aim 1, the Clinical Core will identify, recruit, and follow a pediatric cohort with asthma and an adult cohort with rheumatoid arthritis before and after acute respiratory viral infection. In Specific Aim 2, the Clinical Core will manage the acquisition, processing, and distribution of biologic specimens with associated clinical information. In Specific Aim 3, the Clinical Core will ensure regulatory compliance and the protection of human subjects. To accomplish these aims, the Clinical Core will leverage the existing infrastructure of the Childhood Asthma in Urban Settings (CAUSE) Network and the Benaroya Research Institute at Virginia Mason (BRI). For Research Project 1, the Clinical Core will recruit children with asthma, children with allergic sensitization, and healthy children with no personal history of asthma or allergic sensitizations. For Research Project 2, the Clinical Core will recruit adults with rheumatoid arthritis and healthy adults with no personal or family history of autoimmune disease. The Clinical Core will also be responsible for longitudinal sampling of peripheral blood, nasal swabs, and sputum collected at four in-patient clinic visits: baseline, during acute respiratory viral infection (ARVI; 4-6 days post start of ARVI), 4 weeks post ARVI, and 12 months post baseline. Nasal swabs will also be collected at home at the start and end of ARVI. The Clinical Core will also collect demographic and clinical data using the HIPC clinical characterization template. Samples and linked clinical data will be tracked in the BRI Sample Repository database where datasets can easily be queried for sample selection and provided to research scientists for samples upon unblinding, or to the Data Management & Analysis Core for bioinformatics analysis. The Clinical Core will also be responsible for sample processing as well as sample distribution to each of the Research Projects, the Genomics Core, and the Adaptive Phenotyping Core. The Clinical Core will ensure regulatory compliance and the protection of human subjects by developing and managing registry and study documents including clinical protocols, IRB applications, and informed consent forms. Thus, the Clinical Core has an essential role in ensuring the HIPC Center achieves its scientific objectives.