IMMUNOLOGY QUALITY ASSESSMENT (IQA) PROGRAM

NIAID科学优先事项的核心是需要支持在国内和国际上开展预防和治疗艾滋病毒/艾滋病及其传染性和非传染性并发症的临床研究。本合同的目的是提供资源，以评估和增强美国和非美国实验室（Labs）参与NIAID资助和合作临床研究的能力：（1）监测实验室可靠地进行研究规定的免疫学检测和冷冻保存外周血单核细胞（PBMC）和其他人体生物样本的能力;（2）促进免疫学分析方法的优化、标准化和验证，重点是在NIAID支持的研究中实施的实验室开发的测试（LDT）;（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;及（4）托管及维持电子数据管理系统及文件图书馆，以支援合约活动。 也在合同范围内。

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.