摘要
目的调查临床监查员(clinical research associate,CRA)对上海市医院临床试验服务的满意度,以提升临床试验服务质量。方法2023年10—11月采用典型调查方法和修订的SERVQUAL(service quality)量表对CRA进行问卷调查,内容包括保证性、可靠性、有形性、响应性及移情性等5个维度29个条目。根据修正的服务重要性绩效满意度分析(importance-performance analysis,IPA)明确落入改进区的条目。结果对于来自10家申办者及其委托机构的163名CRA进行问卷调查,回收有效问卷160份。根据修正的IPA象限图,保证性、可靠性、有形性、响应性及移情性维度落入改进区的条目分别为6、2、1、2和2条。结论CRA对上海市医院的临床试验服务可能未达到满意水平,临床试验机构可从规范化意识、审查模式、流程获取、答复响应、管理体系灵活性等方面进行优化,从而提高临床试验服务质量。
Objective To investigate the satisfaction of clinical trial service quality of hospitals in Shanghai for clinical research associate(CRA),so as to provide reference for improving the quality of clinical trial service.Methods From Oct to Nov 2023,CRAs were surveyed using the revised SERVQUAL(service quality)scale.The questionnaire included 29 items in 5 dimensions of assurance,reliability,tangibility,responsiveness and empathy.Based on the modified importance-performance analysis(IPA)analysis,it was figured out which item was in the improvement area.Results A total of 163 CRAs from 10 companies were surveyed,and 160 valid questionnaires were collected.According to the revised IPA,6,2,1,2 and 2 items of the dimensions of assurance,reliability,tangibility,responsiveness and empathy fell into the improvement area,respectively.Conclusion CRAs surveyed may not be satisfied with the clinical trial service of Shanghai hospitals.We need to propose optimization strategies to improve the quality of clinical trial service from the aspects of standardization awareness,review mode,process acquisition,response and management system flexibility.
作者
洪璐
曾涛
何高丽
张晓燕
袁兰芳
张炜
姜桦
HONG Lu;ZENG Tao;HE Gao-li;ZHANG Xiao-yan;YUAN Lan-fang;ZHANG Wei;JIANG Hua(Office of Drug Clinical Trial Institution,Obstetrics and Gynecology Hospital,Fudan University,Shanghai 200011,China)
出处
《复旦学报（医学版）》
CAS
CSCD
北大核心
2024年第5期699-704,735,共7页
Fudan University Journal of Medical Sciences
