Ⅰ期临床试验电子化系统的实践与应用体会  

Practice and application experience of phase Ⅰ clinical trial electronic system

作　　者：陈文君[1] 阮邹荣[1] 楼洪刚[1] 江波[1] CHEN Wen-jun;RUAN Zou-rong;LOU Hong-gang;JIANG Bo(Center of Clinical Pharmacology,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou310009,China)

机构地区：[1]浙江大学医学院附属第二医院临床药理中心,杭州310009

出　　处：《中国新药杂志》2022年第20期2029-2033,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2020 ZX09201022)。

摘　　要：临床试验电子化是未来行业发展的必然趋势。2020年7月,我国国家药品监督管理局颁布的《药物临床试验质量管理规范》(新版GCP)正式施行,其中明确指出“临床试验机构的信息化系统具备建立临床试验电子病历条件时,研究者应当首选使用”。在此背景下,本文结合本中心实践经验总结了临床试验电子化系统在Ⅰ期药物临床试验中的作用和优势,并进一步分析探讨了电子化系统应用的实施要点以及所面临的机遇和挑战。Electronization is an inevitable trend in the development of clinical trials in the future. In July 2020, Good Clinical Practice(new version of GCP) promulgated by National Medical Products Administration was formally implemented, which clearly stated that “When the information system of clinical trial institutions has the conditions to establish electronic medical records for clinical trials, researchers should choose it as a priority for use”. In this context, combining the practical experience of our center, we summarized the role and advantages of the clinical trial electronic system in phase I clinical trials, and further analyzed and discussed the implementation key points of the electronic system, as well as the opportunities and challenges faced.

关 键 词：临床试验电子化系统 临床质量管理规范 作用与优势 关键点 机遇和挑战 

分 类 号：R95[医药卫生—药学]