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: 8328525
• 负责人: STEVEN BRECHER
• 金额: $ 54.06万
• 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/8328525
• 关键词: Adverse effects; Chemicals; Contracts; Data; Data Quality; Databases; Decision Making; Discipline; Ensure; Environmental Exposure; Ethics; Exposure to; Feedback; Hazard Identification; Laboratories; Laboratory Study; National Toxicology Program; Performance; Publications; Records; Regulation; Reporting; Scientist; Support Contracts; Toxicology; Work; disorder prevention; good laboratory practice; meetings; quality assurance; web site

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剂而导致的疾病或不利影响。质量保证（QA）独立审核和检查由合同实验室进行的NTP研究，评估研究行为，记录和报告符合特定合同要求和联邦非临床实验室研究良好实验室规范（GLP）法规的程度。它还在NTP报告出版之前审计NTP报告，并在NTP网站上提供NTP研究的信息和数据。