Clinical Pharmacology Quality Assurance (CPQA)

临床药理学质量保证（CPQA）

• 批准号: 10850504
• 负责人: GENE MORSE
• 金额: $ 232.03万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-30 至 2024-05-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10850504
• 关键词: Acquired Immunodeficiency Syndrome; Biological Assay; Certification; Clinical; Clinical Management; Clinical Pharmacology; Clinical Research; Clinical Trials; Communicable Diseases; Data; Data Management Resources; Development; Enrollment; Ensure; Future; HIV; International; Laboratories; Measurement; Methods; Monitor; National Institute of Allergy and Infectious Disease; Performance; Pharmacology; Pharmacology Study; Prevention Measures; Publishing; Quality Control; Reagent; Sampling; Specific qualifier value; Standardization; Testing; Therapeutic; Training; Validation; clinical research site; improved; pharmacologic; programs; quality assurance

The purpose of NIAID Clinical Pharmacology Quality Assurance (CPQA) Program is to provide a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies. The CPQA Program ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. The program also develops and implements standards of performance for new pharmacology assays, develops and tests methods relating to the assays, and acquires, tests, stores, and dispenses quality control materials and reagents. Thus, the CPQA Program is critical to the scientific integrity of on-going and future studies concerning the assessment of therapeutic and prevention measures for HIV and other infectious diseases.

NIAID临床药理学质量保证(CPQA)计划的目的是为临床药理实验室提供全面的质量评估计划，测试来自NIAID支持的临床研究的受试者的样本。CPQA计划通过向实验室提供药理学熟练程度测试和化验控制的材料，并监测每个实验室的熟练程度和化验数据，确保药理学研究数据的有效性和实验室间和实验室内的可比性。该计划还开发和实施新的药理学分析的性能标准，开发和测试与分析相关的方法，并获取、测试、存储和分配质量控制材料和试剂。因此，CPQA计划对于正在进行的和未来关于评估艾滋病毒和其他传染病的治疗和预防措施的研究的科学完整性至关重要。