药物临床试验质量检查中存在的问题及预防改进措施

Problems in quality inspection of drug clinical trials and preventive measures

通过收集2018年本院在研临床试验的质量检查数据,总结临床试验中常见的问题,对问题进行归类分析,从研究者、药物管理和信息化系统这3个方面探讨问题产生的原因,并提出针对性的预防改进措施,确保药物临床试验的规范性、科学性和安全性。

Through collecting the quality inspection data of clinical trials in our hospital in 2018,summarizing the common problems in clinical trials,classifying and analyzing the problems,this paper probes into the causes of the problems from three aspects of researchers,drug management and information system,and puts forward corresponding preventive measures to ensure the standardization,scientificity and safety of drug clinical trials.