Is there a pre-startup checklist for the preclean line Is it currentpletely filled in)针对预清洁线是否有建立预先点检表单是否已经执行(已经填写)Is there objective evidence that the scrubpreclean chemistries are being analy

单击此处编辑母版标题样式单击此处编辑母版文本样式第二级单击此处编辑母版标题样式单击此处编辑母版文本样式第二级药物临床试验现场稽查复旦大学附属华山医院曹国英2019.04.13现场核查相关法规1现场核查准备2现场核查中3主要内容现场核查后4现场核查要点来源：CFDA 228号公告附件(2015.11)临床试验数据真实可靠相关证据保存完整总体要求现场核查要点7个一致性(系统性查)受试者知情同意书与筛选