PDCA循环法在改进药物临床试验资料管理工作中的应用

Application of PDCA cycle in improving flie management of drug clinical trials

目的：探讨PDCA循环理论在改进药物临床试验资料管理工作中的应用与效果。方法：运用PDCA循环理论,对我院药物临床试验资料管理工作中的常见问题进行原因分析,制订对策;加强药物临床试验准备阶段、进行阶段、完成阶段的分级管理;分级检查资料完整性,进行有效改进。结果：运用PDCA循环理论对药物临床试验资料进行管理后,有效提高了药物临床试验资料完整性合格率,资料完整性合格率由2012年1月～2013年12月实施前29.63%提升至2014年1月～2015年10月实施后88.88%。结论：PDCA循环理论应用于药物临床试验管理工作中,可以有效提高药物临床试验资料的完整性,保证药物临床试验质量科学、可靠。

AIM： To explore the application and effects of PDCA cycle theory in improving data management of drug clinical trials. METHODS： The measures included analyzing the reasons of common problems,developing countermeasures and strengthening classification management for preparation section,progression section and completeness section.Then the file integrity had been grading inspected and effectively improved. RESULTS： The percent incidence of the file integrity had been improved from 33. 33%（ in January 2012 to December 2013）to 100%（ in January 2014 to October 2015） after the application of PDCA cycle theory in data management. CONCLUSION： The application of PDCA cycle theory can effectively improve the data integrity in the file management of drug clinical trials and ensure the quality of drug clinical trials scientific and reliable.