摘要
受全球新型冠状病毒肺炎疫情影响,药物临床试验现场核查工作面临前所未有的严峻挑战。依托互联网和信息化技术平台开展远程核查,是一种创新的药物临床试验核查模式。本文主要基于对我国在境外开展的新型冠状病毒病毒疫苗临床试验核查工作实践,探讨了远程核查方法和面临的挑战,并对相关问题提出建议和对策,以期为今后的药品注册核查工作提供切实可行的新方法和新途径。同时,为临床试验参与各方提供参考和指导,以便其更好地配合远程核查,确保远程核查效率和质量。
Affected by the pandemic of coronavirus disease(COVID-19), the on-site inspection about clinical trial for drug registration is unable to proceed normally. The remote inspection by the Internet and information technology platform is a new regulatory approach for clinical trial. Based on the inspection about overseas clinical trial of COVID-19 vaccine, this paper aims to discuss the methods and challenges of remote inspection about clinical trial and put forward suggestions and countermeasures for relevant problems. It is expected to provide new methods and ways for inspection about clinical trial for drug registration, and supply reference and guidance for all participants involved in clinical trial, arming to cooperate with remote inspection about clinical trial and ensure the efficiency and quality of remote inspection about clinical trial.
作者
张正付
宁靖
张惠芳
王洪
ZHANG Zheng-fu;NING Jing;ZHANG Hui-fang;WANG Hong(Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2022年第6期597-601,共5页
The Chinese Journal of Clinical Pharmacology
关键词
远程核查
现场核查
临床试验
remote inspection
on-site inspection
clinical trial
