IMMUNOLOGY QUALITY ASSESSMENT (IQA) PROGRAM

免疫学质量评估 (IQA) 计划

• 批准号: 10896891
• 负责人: THOMAS DENNY
• 金额: $ 182.57万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10896891
• 关键词: 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; HIV/AIDS; 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; Qualifying; Quality Control; Reagent; Resources; Respondent; Sampling; Site; Specific qualifier value; Standardization; Support Contracts; Testing; Training; United States Food and Drug Administration; Validation; Viral Load result; Whole Blood; 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。本合同的目的是通过以下方式提供资源，以评估和增强美国和非美国实验室 (Labs) 参与 NIAID 资助的合作临床研究的能力：(1) 监测实验室可靠地执行研究特定的免疫学测试和冷冻保存外周血单核细胞 (PBMC) 和其他人类生物样本的能力； (2) 促进免疫测定方法的优化、标准化和验证，重点关注实验室开发的测试（LDT），以在 NIAID 支持的研究中实施； (3) 帮助实验室满足申办方和监管机构对良好临床实验室规范 (GCLP) 的要求，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。 也在合同范围之内。