新型冠状病毒肺炎疫情期间GCP工作开展的实践与思考

    Practice and Consideration for Good Clinical Practice During the Period of COVID-19 Epidemic Situation

    • 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。

       

      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.

       

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