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在国内和国际上支持临床研究进行预防和治疗艾滋病毒/艾滋病的治疗及其感染和非感染的合并症。该合同的目的是提供一种资源来评估和增强美国和非美国实验室（LABS）参与NIAID资助和协作临床研究的能力： （2）促进免疫学分析方法的优化，标准化和验证，重点是实验室开发测试（LDT），以实施NIAID支持的研究； （3）帮助实验室满足良好临床实验室实践（GCLP）的赞助商和监管要求，并将数据提交给监管机构； （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。 也位于合同范围内。