Core B - Human Subjects Core

摘要/摘要 人类受试者核心将为招募人类受试者进行临床试验提供核心资源。 支持项目目标的研究。招募人类受试者进行机制导向的临床研究 方案需要完善的系统，以确保成功招募受试者和收集高风险的数据。 来自特征良好的人类受试者的高质量生物标本。核心将服务于所有项目，它将提供 为安全进行基于人类的研究提供强大的资源。核心研究中心开展的临床研究 涉及复杂的协议，包括虚拟导航支气管镜检查。所需的基础设施 支持这种人类研究是复杂和具有挑战性的，核心是提供经验丰富的，高度 训练有素的人员来迎接这一挑战。因此，核心的首要目的是提供一个人文学科的核心 对于PPG研究者来说，拥有强大的人力资源和有效的参与者招募系统， 协议的安全执行、遵守监管要求和及时招募。第二 核心的目的是在两项临床研究中招募人类参与者，以支持三个PPG项目：（i）“研究 使用图像引导支气管镜检查的哮喘局灶性气道疾病”-“SOFA研究”;该研究值得注意的是， 其使用虚拟导航支气管镜检查允许从粘液中直接收集气道生物样本 堵塞气道和控制气道（气道通畅）;（ii）“鼻息肉病中的组织免疫相互作用-”TIP 研究”。TIP研究因其收集鼻息肉组织和鼻窦粘液样本而闻名。两项研究 将提供来自下气道（SOFA研究）或上气道（TIP研究）2型的高质量生物标本 壁龛

Summary / Abstract The Human Subjects Core will provide a core resource for the recruitment of human participants for clinical studies that support the aims of the projects. Recruiting human subjects for mechanism-oriented clinical research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. The Core will serve all projects, and it will provide strong resources for the safe conduct of human-based research. The clinical studies conducted by the core involve complicated protocols that include virtual navigational bronchoscopy. The infrastructure required to support this kind of human research is complex and challenging and the core provides experienced and highly trained personnel to meet this challenge. Therefore, the first aim of the core is to provide a human subjects core for PPG investigators with strong personnel resources and effective participant recruitment systems to ensure the safe conduct of the protocols, compliance with regulatory requirements, and timely recruitment. The second aim of the core is to enroll human participants in two clinical studies to support the three PPG projects: (i) “Study Of Focal Airway disease in Asthma using Image Guided Bronchoscopy” - “SOFA study”; this study is notable for its use of virtual navigational bronchoscopy to allow directed collection of airway biospecimens from mucus plugged airways and control airways (patent airways); (ii) “Tissue Immune interaction in nasal Polyposis - “TIP study”. The TIP study is notable for its collection of nasal polyp tissue and sinus mucus samples. Both studies will provide high quality biospecimens from either lower airway (SOFA study) or upper airway (TIP study) type 2 niches.