摘要
目的探讨全过程质量控制在Ⅰ期临床试验病房管理中的应用价值。方法在常规Ⅰ期临床试验病房管理基础上施行全程质量控制,实施前后进行效果评价。结果在Ⅰ期临床试验病房管理中实施全过程质量控制后受试者依从性为97.92%,受试者满意度为95.83%,受试者不良事件发生率6.25%,护理差错发生率8.33%,研究者的风险管理意识、临床试验质量管理规范知识、临床试验常用制度/标准操作规程知识、质量控制知识明显提高(P<0.01或P<0.05)。结论在I期临床试验病房管理中施行全过程质量控制可优化Ⅰ期临床病房管理流程,提高临床试验的质量,保护受试者权益。
Objective To discuss the application value of the total quality control in the ward management of phase I clinical trial.Methods Total quality control on the basis of ordinary management was executed and the effects before and after were evalvated.Results After application of total quality control in the ward management of phase I clinical trial,the subjects’compliance rate was 97.92%,and the rate of satisfaction was 95.83%,the rate of infaust events was 6.25%,and the rate of nursing error was 8.33%.The subjects sense of risk control and the knowledge of Good Clinical Practice,Standard Operation Procedure,quality control were enhanced(P<0.01 or P<0.05).Conclusion Apply the total quality control in the ward management of phase I clinical trial can optimize the clinical management process,improve the quality of clinical trials,and project subjects rights.
作者
郭彩会
王娜
宋浩静
孙雪
李颖
董占军
GUO Caihui;WANG Na;SONG Haojing;SUN Xue;LI Ying;DONG Zhanjun(Department of Pharmacy;WardⅡ,Geriatrics Department,Hebei People's Hospital,Shijiazhuang 050051,China)
出处
《护理管理杂志》
2019年第12期889-892,共4页
Journal of Nursing Administration
基金
河北省2019年度医学科学研究重点课题计划项目(20190274)
关键词
Ⅰ期临床试验
病房管理
全过程质量控制
流程优化
phase I clinical trial
ward management
total quality control
process optimization
