Core B - Human Subjects Core

摘要/摘要 人类学科核心将为临床招募人类参与者提供核心资源 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 协议需要完善的系统来确保成功地招募受试者和收集高水平的 高质量的生物标本，来自具有良好特征的人类受试者。核心将为所有项目提供服务，并将提供 为安全开展以人为本的研究提供强大的资源。由CORE进行的临床研究 涉及复杂的方案，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和高度 训练有素的人员来迎接这一挑战。因此，核心的首要目标是提供一个人类主体的核心 对于拥有强大人力资源和有效的参与者招募制度的PPG调查人员，以确保 安全执行规程，遵守监管要求，及时招聘。第二 核心的目的是招募人类参与者参加两项临床研究，以支持三个PPG项目：(I)“研究” 使用影像引导支气管镜检查哮喘中的局灶性呼吸道疾病“-”SOFA研究“；这项研究值得注意的是 它使用虚拟导航支气管镜从粘液中定向收集呼吸道生物检疫杆菌 堵塞呼吸道和控制呼吸道(专利呼吸道)；(Ii)“鼻息肉病的组织免疫相互作用”提示 学习“。TIP研究以收集鼻息肉组织和鼻窦粘液样本而闻名。这两项研究 将提供来自下呼吸道(SOFA研究)或上呼吸道(TIP研究)2型的高质量生物检疫剂 利基市场。

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.