Clinical Core

1摘要-临床核心 2斯坦福大学HIPC U19的临床核心将为所有人提供最先进的临床和生物标本支持。 3研究项目，免疫监测和数据管理和分析核心，以及 4实施和进行拟议的 5临床项目临床中心将为临床研究者提供并更新流程和培训， 6名工作人员;组织、实施、监督和努力提高临床项目绩效;并进行质量控制 纠正措施和处理方案偏离（如需要），包括确保遵守里程碑， 8项目绩效预期，招募和临床表征的标准化方法， 9项适当的人类受试者保护措施和临床良好实践指南。临床核心将 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数据录入和数据管理、质量审查、样本采集（血液、细针穿刺（FNA）和 12个骨髓（BM）穿刺）处理，分离和各种标本类型的编目，并将监督 13所有法规相关文件和IRB合规研究。临床核心将协调临床 14个生物样本存储信息，将临床、生物样本管理和分析管道连接到一个 15个用于临床和转化研究的尖端搜索引擎和分析平台。临床核心将 16由Kari Nadeau博士与副主任Nadine Rouphael博士，UCSF的Long博士和Madhi博士领导， 17努涅斯在S.非洲临床核心将与其他核心和项目密切合作， 18.采用尖端技术对任何样品进行功能分析。纳多，鲁菲尔，朗，麦迪医生 19和Nunez及其团队拥有能够全面作为临床核心的专业知识 20名人员，因为他们在其他NIH相关联盟研究中取得了成功， 其他免疫学临床研究的21项职责，并曾与Pulendran，Davis，Maecker，Khatri和 22博伊德超过15年。核心负责人将代表HIPC中心参加HIPC临床分委员会， 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，包括分享标准作业程序， 24份文件和适当的样本。临床核心提出了以下目标：（1）进行临床 25项关于COVID-19疫苗以及微生物组对狂犬病疫苗接种的影响的研究， 26个数据和样本，以完成研究项目的科学目标;（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 临床研究中的28个方案里程碑、性能指南、沟通策略和依从性，以及 29个样本采集。总之，临床核心将利用最先进的生物标本支持服务， 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