PDCA循环法在改进药物临床试验质量管理工作中的应用.pdf

文档介绍：海峡药学 年 第 卷 第 期
　 2021 　 33 8ening the relevant train-
ing,raising researchers′ awareness of clinical trial thinking and quality control,strengthening the organization′s quali-
RESULTS
ty control and audit by the inspector,then the quality of drug clinical trials had been effectively improved．
　 From January 2016 to December 2018,the rate of non-compliance with quality control in clinical trial project had
decreased． Thc quality had been improved after the application of PDCA cycle theory in quality managemc-
CONCLUSION
nt． 　 Thc application of PDCA cycle theory can effectively improve the quality of drug clinical trials
and ensure the quality of drug clinical trials authentic,scicntific and reliable．
KEY WORDS
:Plan do check action(PDCA);Drug clinical trials;Quality control;Quality management
药物临床试验是新药注册上市前评价其安全性和有效性 个阶段〔2〕 采取措施和持续改进是 循环中的关键环
　 　 。 PDCA
的重要阶段〔1〕 药物临床试验数据的真实 可靠及完整性是 节〔3〕 医院通过将 循环理论运用于药物临床试验项目
, 、 。 PDCA
决定药物临床试验研究结果的基础 因此 加强药物临床试验 质量控制管理中 通过比较