中国药业2022，Vol.31Issue(12)：6-9,4.DOI:10.3969/j.issn.1006-4931.2022.12.002
重庆市药物临床试验研究者GCP参培现状调查
Investigation on Current Status of Clinical Trial Researchers Participating in GCP Training in Chongqing
摘要
Abstract
Objective To improve the training level of Good Clinical Practice (GCP) in Chongqing. Methods Clinical trial researchers (hereinafter referred to as researchers) from 22 drug clinical trial institutions in Chongqing were selected, a questionnaire survey was conducted on their time of exposure to GCP training, ways and methods of participating in GCP learning, GCP training frequency of hospitals and departments, self participation in GCP training, whether the existing GCP training courses met the needs and defects to know the current status of researchers participating in GCP training in the city, and analyze the existing problems of GCP training in the city. The corresponding strategies were put forward. Results A total of 190 questionnaires were distributed on-site, all of which were successfully recovered, including 177 valid questionnaires，with an effective recovery rate of 93. 16%. At present, the GCP training in this city had the following problems: researchers were exposed to GCP training late, the internal organization of the hospital had a low frequency and low emphasis on GCP learning, the content of GCP training was lacking in experts' explanation of hot and difficult points and practical teaching. Most of the reasons why researchers did not participate in the training were lack of time caused by busy work, inconvenient training place and education mode, formalistic training, les s “real McCoy" and higher training fee. Conclusion There are some problems in the current GCP training in Chongqing, such as the popularization of GCP training is insufficient, hospitals and departments has low emphasis on GCP learning, and the existing GCP training courses have defects. In view of the above problems, Chongqing can pilot medical colleges to set up compulsory and elective courses related to clinical trials, encourage hospitals and departments to carry out GCP—related training, build a cross—industry—university—research clinical trial training expert database, and set up a professional training course construction team. The GCP training courses should be increase experts' explanation of hot spots and difficulties，practical case teaching and other contents, increase training interest, multi—location and multi—method training to build online and offline platforms for clinical trial training in Chongqing, reduce training costs, avoid the risk of disease infection, and establish innovative models and methods for continuing training for researchers in Chongqing.关键词
重庆/临床试验质量管理规范/临床试验研究者/培训/药事管理Key words
Chongqing/Good Clinical Practice/clinical trial researcher/training/pharmaceutical administration分类
医药卫生引用本文复制引用
谢江川,李明红,谢林利,曹丽亚,潘辛梅,马攀,陈勇川..重庆市药物临床试验研究者GCP参培现状调查[J].中国药业,2022,31(12):6-9,4.基金项目
重庆市科技计划项目[cstc2018jsyj-zdcxX0079]. （）
