HPTN - CENTRAL LABORATORY

约翰霍普金斯大学(JHU)请求为艾滋病毒预防试验网络(HPTN)建立中央实验室(CL)提供资金。JHU CL将隶属于北卡罗来纳州达勒姆的国际家庭健康协调和运营中心(CORE)以及华盛顿州西雅图的弗雷德·哈钦森癌症研究中心的统计和数据管理中心(SDMC)。具体目标如下：1.为HPTN合作组织和协议团队提供基于实验室的科学领导和咨询。2.参与HPTN协议的制定和审查过程。3.参与HPTN的网络管理和科学议程的制定。4.提供国内和国际HPTN试验标本的处理、存储和检索。5.为艾滋病毒预防试验股(HPTU)现场进行的标本处理、化验性能和与标本有关的数据传输提供质量保证。6.在HPTU临床现场实验室提供实验室质量保证、分析性能和样本运送程序方面的培训和基础设施支持。7.对HPTN方案进行免疫学、药理学和病毒学/细菌学测试。8.开发和评估用于HPTN试验的新检测方法。9.协调各项程序，并及时将准确的实验室数据传送给HPTN SDMC。10.发表新的化验开发/评估和基于发病机制的研究的结果。为了优化所需的科学专业知识和实验室能力，HPTN CL将基于JHU、匹兹堡大学和加州公共卫生部门(VRDL)的中心辐射式概念。

Johns Hopkins University (JHU) requests funding for the establishment of a Central Laboratory (CL) for the HIV Prevention Trials Network (HPTN). The JHU CL will be affiliating with the Coordinating and Operations Center (CORE) at Family Health International in Durham, NC and the Statistical and Data Management Center SDMC) at the Fred Hutchinson Cancer Research Center in Seattle, WA. Specific aims are the following: 1. Provide laboratory based scientific leadership and consultation to the HPTN collaborating organization and protocol teams. 2. Participate in the HPTN protocol development and review process. 3. Participate in the network management and establishment of the HPTN scientific agenda. 4. Provide processing, storage, and retrieval of domestic and international HPTN trial specimens. 5. Provide quality assurance for specimen processing, assay performance, and specimen related data transmission performed at the HIV Prevention Trial Unit (HPTU) sites. 6. Provide training and infrastructure support in laboratory QA, assay performance, and specimen shipping procedures at the HPTU clinical site laboratories. 7. Perform immunologic, pharmacologic, and virologic/bacteriologic testing for the HPTN protocols. 8. Develop and evaluate new assays for use in HPTN trials. 9. Coordinate procedures and timely transmission of accurate lab data to the HPTN SDMC. 10. Publish findings of new assay development/evaluation and pathogenesis based studies. To optimize the amount of scientific expertise and lab capabilities needed, the HPTN CL will be based on a hub and spoke concept involving JHU, University of Pittsburgh, and the California Public Health Dept (VRDL).