QUALITY ASSESSMENT SUPPORT FOR CONDUCT OF AUDITS AND INSPECTIONS

为审计和检查的进行提供质量评估支持

• 批准号: 7789075
• 负责人: STEVEN BRECHER
• 金额: $ 50.97万
• 依托单位: DYNAMAC CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-01-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7789075
• 关键词: QUALITY; ASSESSMENT; SUPPORT; CONDUCT; AUDITS

This contract supports National Toxicology Program (NTP) hazard identification activities targeted toward the prevention of diseases or adverse effects that result from environmental exposure to chemical or physical agents. Quality Assurance (QA) independently audits and inspects NTP studies that are conducted by contract laboratories, assessing the extent to which study conduct, records, and reports comply with specific contractual requirements and federal Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies. It also audited NTP Reports before their publication and information and data for NTP studies that is made available by the NTP web site. Keywords: Quality assurance; assessment; audit; inspect; toxicology; GLP; Good Laboratory Practice regulations; data quality; database; quality management; website

该合同支持国家毒理学计划（NTP）的危害识别活动，旨在预防因环境暴露于化学或物理制剂而导致的疾病或不良影响。质量保证部（QA）独立稽查和检查由合同实验室进行的NTP研究，评估研究实施、记录和报告符合特定合同要求和非临床实验室研究的联邦药物非临床研究质量管理规范（GLP）法规的程度。它还在NTP报告发表前对其进行了审计，并在NTP网站上提供了NTP研究的信息和数据。 保留字：质量保证;评估;审计;检查;毒理学; GLP;药物非临床研究质量管理规范;数据质量;数据库;质量管理;网站