Clinical Immunology Services Core

临床免疫学服务核心

• 批准号: 9631984
• 负责人: Sarah Jane Schlesinger
• 金额: $ 23.07万
• 依托单位: ROCKEFELLER UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9631984
• 关键词: Archives; Clinical; Clinical Immunology; Clinical Protocols; Clinical Trials; Consent; Data; Freezing; Hepatitis B Vaccines; Human; Immunology; Influenza; Institutional Review Boards; Instruction; Pathway interactions; Process; Protocols documentation; Sampling; Services; University Hospitals; Vaccine Adjuvant; Vaccines; human subject protection; vaccine response

The Clinical Immunology Services Core will serve all of the projects in the CCHI. It is at the center of all of the activities in the human immunology clinical trials. The major functions of the core are: Clinical and regulatory support for all of the scientific studies on the samples collected from human clinical immunology trials conducted under the auspices of these projects. The Core will support the consent for the scientific use of and the regulatory requirements associated with the use of human clinical samples that have been collected under previously conducted IRB approved protocols at The Rockefeller University Hospital. These samples are from the seven already IRB approved clinical protocols of experimental vaccines and vaccine adjuvants. The Core will also provide clinical and regulatory support for the conduct of ongoing and planned clinical trials of licensed influenza, pneumococcal, meningicoccal, and hepatitis B vaccines proposed in Projects 1 and 4. The Core will support all of the regulatory, human subjects protection, and clinical execution of these clinical trials. In addition the Clinical Immunology Services Core will also complete all of the data entry and management associated with these proposed protocols.

临床免疫学服务核心将为CCHI的所有项目提供服务。它是世界上所有 人体免疫学临床试验中的活动。核心的主要功能是：临床和 对从人类临床免疫学收集的样本进行的所有科学研究的监管支持 在这些项目的主持下进行的试验。核心将支持对科学使用的同意 以及与使用人类临床样本相关的监管要求 根据之前在洛克菲勒大学医院进行的IRB批准的方案收集的。这些 样本来自IRB已经批准的七种实验性疫苗和疫苗的临床方案 佐剂。该中心还将为正在进行和计划中的 建议对流感、肺炎球菌、脑膜炎和乙肝疫苗进行临床试验 项目1和4。核心将支持所有监管、人类受试者保护和临床 这些临床试验的执行情况。此外，临床免疫学服务核心还将完成所有 与这些提议的协议相关的数据录入和管理。