Clinical Core

临床核心

• 批准号: 10584556
• 负责人: Kari C. Nadeau
• 金额: $ 27.6万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-07 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584556
• 关键词: Ablation; Address; Adherence; Adjuvant; Adult; Africa; Algorithms; Allergic Disease; Allergic Reaction; Antibiotics; Antigens; Automobile Driving; Award; B-Lymphocytes; Bioinformatics; Biological Assay; Biological Markers; Blood; Bone Marrow Aspiration; COVID-19 vaccine; Cataloging; Cells; Clinical; Clinical Immunology; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communication; Computer Models; Cytometry; Data; Data Analyses; Data Security; Data Storage and Retrieval; Databases; Development; Ensure; Exposure to; Fine needle aspiration biopsy; Goals; Good Clinical Practice; Guidelines; Hospitals; Human; Human Resources; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Influenza; Informatics; Infrastructure; Institutional Review Boards; Longitudinal Studies; Measures; Messenger RNA; Molecular Profiling; Monitor; National Institute of Allergy and Infectious Disease; Natural Immunity; Nature; Performance; Pfizer-BioNTech COVID-19 vaccine; Plasma; Population; Practice Guidelines; Predisposition; Procedures; Process; Protocols documentation; Quality Control; RNA vaccine; Rabies; Recombinants; Recommendation; Reporting; Research; Research Personnel; Research Project Grants; Role; Sampling; Saponins; Scientific Advances and Accomplishments; Services; South African; Special Population; Specimen; Standardization; System; T cell response; T-cell receptor repertoire; Technology; Training; Translational Research; United States National Institutes of Health; Update; Vaccination; Vaccines; Validation; Work; adaptive immunity; antigen-specific T cells; biological systems; clinical training; cytokine; data integration; data management; data submission; epigenomics; expectation; human subject; human subject protection; immunoregulation; improved; influenza virus vaccine; metabolomics; microbiome; microbiota; multiple omics; new technology; novel; public database; recruit; response; sample collection; search engine; seasonal influenza; single cell analysis; transcriptomics; vaccine development; vaccinology

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

1摘要 - 临床核心 2 Stanford HIPC U19的临床核心将为所有人提供最先进的临床和生物测量支持 3研究项目，免疫监控以及数据管理和分析核心以及 4专业知识，设施，人员，程序和程序，用于实施和行为 5个临床项目。临床核心将为临床研究人员提供和更新过程和培训 6名员工；组织，实施，监控和努力以提高临床项目绩效；并进行质量控制 7以及纠正措施和处理协议出发（如果需要的话），包括确保遵守里程碑， 8项目绩效期望，招聘和临床表征的标准化方法， 9适当的人类主题保护措施和临床良好实践指南。临床核心将 10提供临床研究单元，其中包括用于纵向研究的基础设施：招聘，保留，保留， 11数据输入和数据管理，质量审查，样本收集（血液，细针吸入（FNA）和 12个骨髓（BM）抽吸物）处理，各种样品类型的隔离和分类，并将监督 13所有与监管相关的文件和IRB符合IRB的研究。临床核心将协调临床 14个生物循环存储信息，将临床，生物测量管理和测定管道连接到一个 15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博士领导，副主任Nadine Roupael博士，UCSF的Long博士和Drs。 Madhi和 17 Nunez在非洲的医院。临床核心将与其他核心和项目紧密合作，以启用 18使用最先进技术的所有样品的功能分析。博士。 Nadeau，Rouphael，Long，Madhi， 19和Nunez及其团队具有专业知识，能够全面充当临床核心 20名人员以来，他们在其他与NIH相关的联盟研究中都取得了成功，在执行临床核心方面 其他免疫学临床研究的21个职责，并与博士合作。 Pulendran，Davis，Maecker，Khatri和 22 Boyd超过15年。核心负责人将在HIPC临床小组委员会中代表HIPC中心 23将在HIPC协调中心下运营，以促进跨职协作，包括共享SOP， 24个文档，以及适当的样品。临床核心提案以下目的：（1）执行临床 25对Covid-19疫苗的研究以及微生物组对兔疫苗的影响，以提供临床 26个数据和样本以实现研究项目的科学目标； （2）建立并维护 27人事培训，程序和程序提供核心临床支持； （3）建立和维护 28临床研究中的协议里程碑，绩效指南，沟通策略和合规性 29样品收集。总而言之，临床核心将利用最先进的生物环境支持服务和 30将协调HIPC U19项目研究的所有操作和监管方面。 31