药物临床试验数据核查临床部分常见问题的原因分析及控制措施

Cause analysis and control measures of common problems in clinical part from drug clinical trial data inspection

自国家食品药品监督管理总局发布《关于开展药物临床试验数据自查核查工作的公告》(2015年第117号)以来,药物临床试验数据核查取得了阶段性成果。本文对2015年7月至2017年6月在药物临床试验数据核查中发现的临床部分常见问题进行了原因分析并提出相关控制措施,包括临床试验过程记录及临床检验检查等数据溯源、方案执行、试验用药品管理、安全性数据记录和报告、受试者筛选/入组和知情同意书签署等。

The clinical trial data inspection has achieved the phased objectives since China Food and Drug Administration issued the announcements about clinical trial data self-inspection and verification. This paper analyzed findings of clinical trial data inspections conducted from July 2015 to June 2017 and put forward corresponding control measures to common problems, which existed in the records and traceability of clinical data and medical examination, protocol compliance, investigational drug management, recording and reporting of safety information, screening and inclusion of subjects, obtaining of informed consent, and so on.