显示页面修订记录反向链接回到顶部 本页面只读。您可以查看源文件,但不能更改它。如果您觉得这是系统错误,请联系管理员。 CKG 可视编辑器 ====== 稽查 Audit ====== \\ **稽查**:指对临床试验相关活动和文件进行系统的、独立的检查,以评估确定临床试验相关活动的实施、试验数据的记录、分析和报告是否符合试验方案、标准操作规程和相关法律法规的要求。(([[法规:药物临床试验质量管理规范#第二章_术语及其定义|药物临床试验质量管理规范(GCP)]]. [[概念:国家药品监督管理局]]. 2020)) **Audit**:A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016)) \\ 概念/稽查.txt 最后更改: 2年前由 老T