Clinical Core

1摘要-临床核心 2斯坦福HIPC U19的临床核心将为所有患者提供最先进的临床和生物医学支持 3研究项目、免疫监测和数据管理与分析核心，以及 4执行和实施拟议方案的专门知识、设施、人员、程序和程序 5个临床项目。临床核心将为临床研究人员提供和更新流程和培训 6名员工；组织、实施、监督和改进临床项目绩效；进行质量控制 7以及纠正措施和处理协议偏差(如果需要)，包括确保遵守里程碑； 8项目业绩预期，招募和临床特征方面的标准化方法， 9适当的人体主体保护措施和临床良好实践指南。临床核心意志 10提供临床研究单位，包括纵向研究的基础设施：招募、保留、 11数据输入和数据管理、质量审查、样本采集(血液、细针抽吸(FNA)和 12骨髓(BM)对不同类型的标本进行处理、分离和编目，并将监督 13所有与法规相关的文件和符合IRB的研究。临床核心将协调临床 14生物样品存储信息学，将临床、生物样品管理和检测管道连接到 15为临床和翻译研究的尖端搜索引擎和分析平台。临床核心意志 16由Kari Nadeau博士领导，副主任Nadine Rouphael博士，UCSF Long博士，Madhi博士和 17努涅斯在南非的医院里。临床核心将与其他核心和项目密切合作，以实现 18对任何具有尖端技术的样品进行功能分析。Nadeau博士，Rouphael博士，Long，Madhi博士， 19和努涅斯和他们的团队拥有专业知识，能够全面担任临床核心 20名人员，因为他们在NIH的其他相关联盟研究中成功地执行了临床核心 负责其他免疫学临床研究，并曾与Pulendran，Davis，Maecker，Khatri和 22岁的博伊德已经15年了。核心领导将代表重债穷国中心参加重债穷国临床小组委员会，该小组委员会 23将在重债穷国协调中心下运作，以促进重债穷国之间的合作，包括共享标准作业程序， 24份文件，并视情况提供样本。临床核心提出了以下目标：(1)执行临床 25与新冠肺炎疫苗的研究，以及关于微生物群对狂犬病疫苗接种的影响，为临床提供 完成研究项目科学目标的26个数据和样本；(2)建立和维护 27提供核心临床支持的人员培训、程序和流程；以及(3)建立和维护 28临床研究中的方案里程碑、绩效指南、沟通策略和遵从性 29个样本采集。总而言之，临床核心将利用最先进的生物显微镜支持服务和 30将协调重债穷国U19项目研究的所有业务和监管方面。 31

1 ABSTRACT – Clinical Core 2 The Clinical Core of the Stanford HIPC U19 will provide state-of-the-art clinical and biospecimen support for all 3 the research projects, the Immune Monitoring and the Data Management and Analysis Cores, as well as the 4 expertise, facilities, personnel, procedures and processes for the implementation and conduct of the proposed 5 clinical projects. The Clinical Core will provide and update processes and training for clinical investigators and 6 staff; organize, implement, monitor and work to improve clinical project performance; and conduct quality control 7 and corrective action and handle protocol deviations (if needed), including assuring adherence to milestones, 8 project performance expectations, standardized approach in the recruitment and clinical characterization, 9 appropriate human subject protection measures and clinical Good Practice Guidelines. The Clinical Core will 10 provide the clinical research units which include the infrastructure for longitudinal studies: recruitment, retention, 11 data entry and data management, quality review, sample collection (blood, fine needle aspiration (FNA) and 12 bone marrow (BM) aspirates) processing, isolation and cataloging of various specimen types and will oversee 13 all regulatory-related documents and IRB compliant research. The Clinical Core will coordinate clinical 14 biospecimen storage informatics, connecting clinical, biospecimen management, and assay pipelines into a 15 cutting-edge search engine and analysis platform for clinical and translational research. The Clinical Core will 16 be led by Dr. Kari Nadeau with Associate Director Dr. Nadine Rouphael, Dr. Long at UCSF, and Drs. Madhi and 17 Nunez at hospitals in S. Africa. The Clinical Core will work closely with the other cores and projects to enable 18 the functional analysis of any samples with cutting-edge technologies. Drs. Nadeau, Rouphael, Long, Madhi, 19 and Nunez and their teams have the expertise to be able to comprehensively serve as the Clinical Core 20 personnel since they have been successful in other NIH related consortium studies, in performing Clinical Core 21 duties for other immunology clinical studies, and have worked with Drs. Pulendran, Davis, Maecker, Khatri and 22 Boyd for over 15 years. The Core Leader will represent the HIPC center in a HIPC Clinical Sub-Committee that 23 will operate under the HIPC Coordinating Center to promote cross-HIPC collaboration including sharing SOPs, 24 documents, and samples as appropriate. The Clinical Core proposes the following aims: (1) To perform clinical 25 studies with COVID-19 vaccines, and on the impact of the microbiome on rabies vaccination, to provide clinical 26 data and samples to accomplish the scientific goals of the research projects; (2) Establish and maintain 27 personnel training, procedures, and processes to provide core clinical support; and (3) Establish and maintain 28 protocol milestones, performance guidelines, communication strategies, and compliance in clinical studies and 29 sample collection. In summary, the Clinical Core will leverage state-of-the-art biospecimen support services and 30 will coordinate all operational and regulatory aspects of research for the HIPC U19 projects. 31