药物临床试验的稽查内容o 质量与质量保障(Quality Assurance) 组织n 定义n 职责o 稽查n 定义n 实施程序n 稽查目的o 稽查与视察o 稽查中发现的问题2006-12-14 2什么是“质量”?“质量”是: 按照预先制定的、有控制的规程操作，以期得到能满足客户期望的研究成果和服务。 The execution of well-defined, controlled processes that deliver products and services which meet customer expectations.2006-12-14 3“质量保障”的定义ICH GCP 1.46 所有有计划、有系统地制定，以确保临床试验能以符合GCP 规范和相关法规要求的规程实施的措施。All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded
