IMMUNOLOGY QUALITY ASSESSMENT (IQA) PROGRAM

国家艾滋病研究所科学优先事项的核心是需要支持开展临床研究，以便在国内和国际上预防和治疗艾滋病毒/艾滋病及其传染性和非传染性合并症。本合同的目的是提供一个资源来评估和提高美国和非美国的能力。实验室（实验室）通过以下方式参与niaid资助和合作的临床研究：(1)监测实验室可靠地进行研究指定的免疫学测试和冷冻保存外周血单个核细胞（PBMCs）和其他人类生物样本的能力；(2)促进免疫分析方法的优化、标准化和验证，重点是实验室开发的测试（LDTs）在niaid支持的研究中实施；(3)帮助实验室满足良好临床实验室规范（GCLP）的申办者和监管要求，并向监管机构提交数据；(4)托管和维护电子数据管理系统和文档库，以支持合同活动。

Central to NIAID scientific priorities is the need to support the conduct of clinical studies for the prevention and treatment of HIV/AIDS and its infectious and non-infectious co-morbidities, domestically and internationally. The purpose of this contract is to provide a resource to evaluate and enhance the ability of U.S. and non-U.S. laboratories (Labs) to participate in NIAID-funded and collaborative clinical studies by: (1) monitoring the ability of Labs to reliably perform study-specified immunological tests and cryopreserve peripheral blood mononuclear cells (PBMCs) and other human biological samples; (2) facilitating the optimization, standardization and validation of immunological assay methodologies, with focus on laboratory-developed-tests (LDTs) for implementation in NIAID-supported studies; (3) helping Labs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP) and submission of data to regulatory agencies; and (4) hosting and maintaining an electronic data management system and document library in support of contract activities. are also within the scope of the contract.