摘要
目的了解医务工作者对药物临床试验质量管理规范(GCP)知识的熟悉程度。方法于2018-07-26-2018-08-10通过微信发送电子问卷进行横断面调查。对问卷调查结果的正确率、分数分布和不同人群的知识了解情况等主要指标进行统计分析。结果合计收到284份问卷,其中有效问卷237份。在237份问卷中,平均正确率为76.9%,其中知情同意(65.2%)、研究文件(67.5%)和研究者资质与职责(70.8%)正确率相对较低,而对质量控制(83.5%)和研究药物(91.4%)掌握较好。分层分析发现:得分较低人群为年龄≥35岁人群(69.7±13.5)分,工作年限≥10年(67.6±13.6)分,教育程度为大专及以下人群(72.7±14.4)分,编内人员(71.1±13.3)分,中级职称(73.2±14.2)分,管理(70.3±17.7)分,而按照性别和专业分类差异均无统计学意义。结论上海市胸科医院医务工作者对GCP知识了解程度整体较好,但是有必要开展GCP知识培训。
Objective To understand the familiarity of medical workers with the knowledge on the good clinical practice(GCP)of drug clinical trials.Methods A cross-sectional survey was conducted from July 26,2018 to August 10,2018 by sending an electronic questionnaire via WeChat.The main indexes including accuracy,score distribution and knowledge understanding of different populations were statistically analyzed.Results A total of 284 questionnaires were collected,including 237 valid ones.Among the 237 questionnaires,the average accuracy was 76.9%,among which informed consent(65.2%),research documents(67.5%)and researchers’qualifications and responsibilities(70.8%)showed relatively low accuracy,while quality control(83.5%)and researched drugs(91.4%)were well mastered.Stratified analysis revealed that the population with low score aged≥35 years accounted for(69.7±13.5),the population with working years≥10 years for(67.6±13.6),the population with education level of junior college and below for(72.7±14.4),in-staff personnel for(71.1±13.3),the population with medium-grade professional title for(73.2±14.2),and managers for(70.3±17.7).However,no statistically significant diffe-rences were found in the stratified analysis based on gender and major classification.Conclusion The medical workers in Shanghai Chest Hospital have an overall good understanding of knowledge on GCP,but it is necessary to carry out GCP knowledge training.
作者
卢芳
陈仲林
吕梦军
陶晓捷
戴志琴
汪月
舒扬
韩宝惠
李榕
LU Fang;CHEN Zhong-lin;LU Meng-jun;TAO Xiao-jie;DAI Zhi-qin;WANG Yue;SHU Yang;HAN Bao-hui;LI Rong(Department of Science and Education,Shanghai Chcst Hospital,Shanghai Jiaotong Unizersity,Clinical Research Institute,Shanghai 200030,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2020年第2期200-202,共3页
The Chinese Journal of Clinical Pharmacology
基金
国家自然科学基金资助项目(81773273)
"医师系列"第二梯队人才培养计划资助项目
上海交通大学中国医院发展研究院2019年度医院管理建设项目(CHDI-2019-B-18)。
