PDCA循环法在SIDCER评估工作中的应用——以东南大学附属中大医院临床研究伦理委员会为例  

Application of PDCA cycle in SIDCER survey——based on IEC for clinical research of Zhongda hospital,affiliated to Southeast University

作　　者：王慧萍[1] 周人 谢波[1] 张莉莉[1] 孙晓如[2] 

机构地区：[1]东南大学附属中大医院临床试验机构办公室 [2]江苏省计划生育科学技术研究所

出　　处：《中国临床药理学与治疗学》2015年第12期1401-1404,1422,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：东南大学附属中大医院临床研究伦理委员会尝试将PDCA循环管理的理念和方法应用于SIDCER评估工作中,并于2013年顺利通过SIDCER评估。首先,通过头脑风暴法和鱼骨图分析法发现伦理委员会存在的主要问题并制定了SIDCER评估工作计划。其次,根据现状分别从组织管理、制度管理、培训管理、档案管理等四个方面执行工作计划。再次,通过现场评估检验实施效果。最后,分析SIDCER评估反馈意见,制定整改计划,进入新的PDCA循环。Independent Ethics Committee for Clinical Research, Affiliated Zhongda Hospital of Southeast University tried to use PDCA（ Plan-DoCycle-Action） cycle during the SIDCER（ strategic initiative for developing capacity in ethical review）survey,and became the recognized ethics committee in 2013. Firstly,using brainstorming and fishbone diagram analysis, make the preparation plan for SIDCER survey based on the major problems of Independent Ethics Committee for Clinical Research.Secondly,adopted four corresponding countermeasures based on the current situation,including organization management,institution management,training management and file management. Then,tested the effect improvement through the site visit. Finally,made the corrective action plan through analysis of the survey and evaluation report,and put forward the next stage PDCA cycle.

关 键 词：PDCA循环 SIDCER评估 伦理委员会 

分 类 号：R951[医药卫生—药学]