基于ISO 9001标准的I期临床试验护理质量管理指标体系构建与应用  

Construction and Application of a Phase I Clinical Trial Nursing Quality Management Index System Based on ISO 9001 Standard

作　　者：耿燕 孙小玲 黄雷 曹蓓 倪源君 应晨 翁祖怡 GENG Yan;SUN Xiaoling;HUANG Lei(Nanjing Drum Tower Hospital,Nanjing,Jiangsu,210031,China;不详)

机构地区：[1]南京鼓楼医院,江苏南京210031

出　　处：《中国卫生质量管理》2024年第8期58-62,共5页Chinese Health Quality Management

基　　金：2023年度国家卫生健康委医院管理研究所医疗质量(循证)管理研究项目(编号:YLZLXZ23G082)。

摘　　要：目的识别I期临床试验中护理质量问题与管理节点,构建基于ISO 9001标准的I期临床试验护理质量管理指标体系。方法通过文献回顾、头脑风暴、专家咨询等确定指标体系,并于2023年11月-2024年1月进行初步应用。结果建立了包含8个一级指标、54个二级指标的I期临床试验护理质量管理指标体系。应用后,I期临床试验的仪器设备使用规范性、数据录入规范性以及方案执行依从性均得以提高。结论基于ISO 9001标准的I期临床试验护理质量管理指标体系具有一定科学性和实用性,可用于临床试验护理质量管理。Objective To identify the nursing quality issues and management nodes involved in phase I clinical trial and construct a nursing quality management index system based on the ISO 9001 standard.Methods The index system was determined through literature review,brainstorming,expert consultation,etc.,and the initial application was carried out from November 2023 to January 2024.Results A phase I clinical trial nursing quality management index system with 8 primary indicators and 54 secondary indicators was established.After the application,the standardization of the use of instruments and equipment,the standardization of data entry and the compliance of protocol implementation in Phase I clinical trial were improved.Conclusion The Phase I clinical trial nursing quality management index system based on ISO 9001 standard is scientific and practical,and can be used for clinical trial nursing quality management.

关 键 词：Ⅰ期临床试验 ISO 9001标准 护理管理 护理质量 

分 类 号：R47[医药卫生—护理学]