| 新型冠状病毒肺炎疫情期间GCP工作开展的实践与思考 |
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| 引用本文： | 黄玉洁,翟优,刘健,周惠丽,黄倩,王远方,吴国兰,胡兴江,梁星光,吴丽花,赵青威. 新型冠状病毒肺炎疫情期间GCP工作开展的实践与思考[J]. 中国现代应用药学, 2020, 37(7): 777-781 |
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| 作者姓名： | 黄玉洁 翟优 刘健 周惠丽 黄倩 王远方 吴国兰 胡兴江 梁星光 吴丽花 赵青威 |
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| 作者单位： | 浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院,浙江大学医学院附属第一医院 |
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| 基金项目： | “十三五”浙江省中医药（中西医结合）重点学科建设计划（2017-XK-A35）；浙江省科技厅重点研发计划应急攻关项目（2020C03123） |
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| 摘 要： | 新型冠状病毒疫情等突发公共卫生事件的爆发严重影响医院临床试验工作的开展。笔者所在浙江大学医学院附属第一医院临床药学研究中心结合国家卫生健康委员会相关规定与指南,针对我院临床试验开展情况,通过多层次培训临床试验相关人员,合理统筹和协调临床试验开展。采用电子信息化等方式,降低疫情流动传播风险,优化工作流程,并积极协调本院新型冠状肺炎相关临床试验的开展。笔者结合近期在新型冠状病毒期间临床试验工作开展的具体实践,总结经验和思考,以期为突发公共事件下临床试验的管理提供参考和建议。
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| 关 键 词： | 新型冠状病毒肺炎 临床试验 项目与人员管理 临床试验药物管理 伦理审查 |
| 收稿时间： | 2020-03-07 |
| 修稿时间： | 2020-03-30 |
Practice and Consideration for Good Clinical Practice During the Period of COVID-19 Epidemic Situation |
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| HUANG Yujie,ZHAI You,LIU Jian,ZHOU Huili,HUANG Qian,WANG Yuanfang,WU Guolan,HU Xingjiang,LIANG Xingguang,WU Lihu,ZHAO Qingwei. Practice and Consideration for Good Clinical Practice During the Period of COVID-19 Epidemic Situation[J]. The Chinese Journal of Modern Applied Pharmacy, 2020, 37(7): 777-781 |
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| Authors: | HUANG Yujie ZHAI You LIU Jian ZHOU Huili HUANG Qian WANG Yuanfang WU Guolan HU Xingjiang LIANG Xingguang WU Lihu ZHAO Qingwei |
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| Affiliation: | First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University,First Affiliated Hospital, School of Medicine, Zhejiang University |
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| Abstract: | The public health events such as the outbreak of novel coronavirus affected the of clinical trials?carried out in hospitals. During the outbreak of novel coronavirus pneumonia, we takes a series of management to ensure the safe and effective development of clinical trials. We adjusted the arrangements of clinical trial by optimizing the workflow, and carried out the new clinical trials related to coronary pneumonia. Herein, we summerized the experience of the?management in clinical trials in our hospital during the outbreak of novel coronavirus pneumonia, and so to provide reference and suggestions for the management of clinical trials under public emergencies. |
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| Keywords: | COVID-19 clinical trial management of clinical trial management of clinical test drug ethical review |
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