摘要
目的:通过药物临床试验伦理审查信息化体系的建设,提高我院药物临床试验伦理审查质量、效率、审查环节的规范化及前瞻性管理。方法:基于云架构设计整个信息化系统,实现所有伦理审查申请者、伦理委员会使用同一个系统在线注册、在线开展业务,为区域伦理委员会的业务模式、多中心伦理互认提供了一种信息化解决方案。结果:通过云架构的伦理审查平台建设,已实现伦理资料的无纸化、电子化管理,实现了手机端、电脑端的在线会议审查、跟踪审查和远程视频会议。结论:伦理审查体系信息化建设提高了药物临床试验的伦理审查效率和管理水平。
AIM:To improve the quality,efficiency,standardization and prospective management of ethical review of drug clinical trials in our hospital through the information system construction of ethical review of drug clinical trials.METHODS:The entire information system was designed based on the cloud architecture,enabling all ethics review applicants and ethics committees to use the same system for online registration and online business,which provided an information solution for the business model of regional ethics committees and multi-center ethics mutual recognition.RESULTS:Through the construction of ethical review platform of cloud architecture,the paperless and electronic management of ethical data have been realized,and online meeting review,tracking review and remote video conference have been realized on mobile and computer terminals.CONCLUSION:The information construction of ethical review system improves the efficiency and management level of ethical review in drug clinical trials.
作者
佘志华
陈舟
梁松岳
SHE Zhihua;CHEN Zhou;LIANG Songyue(Hunan Provincial Maternal and Child Health Care Hospital,Changsha 410008,Hunan,China;Changsha Tonoinfo Technlogy Co.,Ltd.,ChangSha 410008,Hunan,China)
出处
《中国临床药理学与治疗学》
CAS
CSCD
2021年第9期1023-1030,共8页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
湖南省自然科学基金-科药联合基金(2020JJ9028)。
关键词
临床试验
伦理审查
信息化
云架构
clinical trials
ethical review
informationize
cloud architecture
