浅谈临床试验的稽查  

Glimpse on Clinical Trial Auditing

作　　者：范大超[1] 

机构地区：[1]ICON控股临床研究国际有限公司

出　　处：《中国处方药》2010年第9期70-71,共2页Journal of China Prescription Drug

摘　　要：如果稽查中发现问题很严重,尤其这些问题对数据的影响面很大时,某个试验医院的研究数据可能无效,新药申请可能被延迟,甚至不被批准。研究者也可能因此被禁止开展临床试验。If serious problems are found in clinical trial auditing,particularly when the impact of the revealed problem on the data is large,the research data from a certain hospital where clinical trial site is located may be invalid,new drug application may be delayed,or even result in disapproval of new drug application. Researchers may therefore be prohibited to conduct clinical trials.

关 键 词：新药临床试验 稽查 临床试验数据 合同研究组织 临床数据 药政法规 质量 竞争力 

分 类 号：R95[医药卫生—药学]