CRA和CRC等对某三甲医院临床试验机构满意度调查研究  

Investigation on the Satisfaction of CRA and CRC with the Clinical Trial Institution in a Third-class Hospital

作　　者：谭朝丹 施燕[1] TAN Zhao-dan;SHI Yan(The GCP Department,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200123,China)

机构地区：[1]同济大学附属东方医院GCP机构办公室,上海200123

出　　处：《海峡药学》2025年第1期81-85,共5页Strait Pharmaceutical Journal

基　　金：2022年度浦东新区卫生系统优秀青年医学人才培养计划(PWRq2022-046)。

摘　　要：目的通过对CRA和CRC等进行临床试验机构满意度调查,探索机构管理工作存在问题和改进措施。方法以方便抽样联合滚雪球抽样的非概率混合抽样方式,利用问卷星以及微信平台对CRA、CRC等人员进行了问卷调查,问卷内容包括基本信息和对临床试验机构工作各方面内容的满意度。结果回收有效问卷110份,有效回收率为100.00%,总体满意度为86.36%。经logistic二元回归分析,被调查人员的年龄、学历和所在地区会显著影响总体满意度(P=0.008;0.046;0.030);对机构立项、伦理、质控、药物管理等9个工作模块的满意度无差别(χ^(2)检验,P=0.160);对于工作环境、数据溯源等10个细节的满意度χ^(2)检验表明,对免费检验检查系统的满意度最高(100.00%),对机构办公室人员数量配比的满意度最低(76.36%),差异有统计学意义(P<0.01);对于反馈时限、信息系统、财务流程、接待频率和沟通途径等收集了若干意见和建议。结论为提高临床试验机构管理质量,机构采取对CRA和CRC等进行满意度调查问卷的方式,可收集全面真实的反馈信息作为整改方向,该方法便利有效、值得推广。OBJECTIVE Investigation on the satisfaction of CRA(Clinical Research Associate)and CRC(Clinical Research Coordinator)with the clinical trial institution,was conducted to dig out the malpractice of the GCP(Good Clinical Practice)institution office and provide reference to improve the administration quality.METHODS The mixed sampling method of convenient sampling and snowball sampling,was designed to launch the investigation,with the help of Questionnaire Star software and the WeChat software,and the questionnaires involved basic information and satisfaction of participants with the clinical trial institution in a third-class hospital.RESULTS 110 valid questionnaires were recovered,with the effective recovery rate of 100.00%,and the overall satisfaction rate is 86.36%.Age,academic background,and location of participants,could obviously affect the satisfaction(P=0.008;0.046;0.030,by binary logistic regression analysis).The satisfaction on 9 fields,including project set-up,ethical review,quality assurance,drug administration and etc,showed no significant difference(P=0.160,by Chi-square test).As for work environment,data trace and other 8 aspects,anticipants'satisfaction was different(P<0.01,by Chi-square test),with the highest satisfaction of 100.00% on free examination system and the lowest of 76.36% on office personnel setting.Besides,advice and suggestion was collected,involving feedback time,CTMS(Clinical Trial Manage System),financial affairs,reception frequency,and communication channel.CONCLUSION Questionnaire on satisfaction from CRA and CRC,was an affective and convenient way to collect and solve questions,so as to improve the administration of clinical trial office,deserving promoted and popularized.

关 键 词：临床试验机构 满意度 调查 CRA CRC 

分 类 号：R95[医药卫生—药学]