| 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. |
| HUANG Yujie,ZHAI You,LIU Jian,ZHOU Huili,HUANG Qian,WANG Yuanfang,WU Guolan,HU Xingjiang,LIANG Xingguang,WU Lihua,ZHAO Qingwei.Practice and Consideration for Good Clinical Practice During the Period of COVID-19 Epidemic Situation[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(7):777-781. |
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| 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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黄玉洁1,2, 翟优1,2, 刘健1,2, 周惠丽1,2, 黄倩1,2, 王远方1,2, 吴国兰1,2, 胡兴江1,2, 梁星光1, 吴丽花1,2, 赵青威1,2
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1.浙江大学医学院附属第一医院, 杭州 310003;2.浙江省药物临床研究与评价技术重点实验室, 杭州 310003
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| 摘要: |
| 新型冠状病毒肺炎疫情等突发公共卫生事件的暴发严重影响医院临床试验工作的开展。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，针对院内临床试验开展情况，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，并积极协调新型冠状病毒肺炎相关临床试验的开展。本文结合新型冠状病毒肺炎疫情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。 |
| 关键词: 新型冠状病毒肺炎 临床试验 药品临床试验管理规范 临床试验药物管理 伦理审查 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.07.002 |
| 分类号:R969.4 |
| 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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| Practice and Consideration for Good Clinical Practice During the Period of COVID-19 Epidemic Situation |
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HUANG Yujie1,2, ZHAI You1,2, LIU Jian1,2, ZHOU Huili1,2, HUANG Qian1,2, WANG Yuanfang1,2, WU Guolan1,2, HU Xingjiang1,2, LIANG Xingguang1, WU Lihua1,2, ZHAO Qingwei1,2
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1.The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China;2.Key Laboratory of Drug Clinical Research and Evaluation Technology of Zhejiang Province, Hangzhou 310003, China
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| Abstract: |
| The public health events such as the COVID-19 epidemic situation affected of the clinical trials carried out in hospitals. During the period of COVID-19 epidemic situation, the department of clinical trail institutions of the First Affiliated Hospital, College of Medicine, Zhejiang University, had taken a series of management to ensure the safely and effectively development of clinical trials. They adjusted the arrangements of clinical trial by optimizing the workflow, and carried out the new clinical trials related to COVID-19. Herein, the experience of the management in good clinical practice during the period of COVID-19 epidemic situation was summarized, and to provide reference and suggestions for the management of clinical trials under public emergencies. |
| Key words: COVID-19 clinical trial good clinical practice(GCP) management of clinical test drug ethical review |
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