IMMUNOLOGY QUALITY ASSESSMENT (IQA) PROGRAM

免疫学质量评估 (IQA) 计划

• 批准号: 10653768
• 负责人: THOMAS DENNY
• 金额: $ 173.56万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10653768
• 关键词: AIDS/HIV problem; Accreditation; Acquired Immunodeficiency Syndrome; Biological; Biological Assay; Biometry; CD4 Positive T Lymphocytes; Clinical; Clinical Research; Contracts; Cryopreservation; Data; Data Management Resources; Educational workshop; European; Evaluation Methodology; Freezing; Funding; HIV Seropositivity; Human; Immunologic Tests; Immunologics; Immunology; Immunology procedure; International; Laboratories; Leukapheresis; Libraries; Medicine; Methodology; Monitor; National Institute of Allergy and Infectious Disease; Peripheral Blood Mononuclear Cell; Plasma; Prevention; Process; Quality Control; Reagent; Resources; Respondent; Sampling; Site; Specific qualifier value; Standardization; Statistical Data Interpretation; Support Contracts; Testing; Training; United States Food and Drug Administration; Validation; Viral Load result; Whole Blood; base; comorbidity; computerized; data submission; electronic data; performance tests; programs

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.

NIAID科学优先事项的核心是需要支持开展预防和治疗艾滋病毒/艾滋病及其在国内和国际上的传染性和非传染性共病的临床研究。本合同的目的是提供一种资源，以评估和提高美国和非美国实验室(Labs)参与NIAID资助的协作临床研究的能力，方法是：(1)监测Labs可靠地执行特定研究的免疫学测试和冷冻保存外周血单个核细胞(PBMC)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(LDT)，以便在NIAID支持的研究中实施；(3)帮助实验室满足赞助商和监管机构关于良好临床实验室操作规范(GCLP)和向监管机构提交数据的要求；以及(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。 也在合同的范围内。