摘要
目的在药物临床试验中引入全过程电子信息化管理新模式,提高临床试验运行效率,为其他药物临床试验机构提供参考。方法依照临床试验运行过程,介绍并分析临床试验信息化平台功能特点及优势,并对比传统手工模式管理成效。结果电子信息化系统在不同的操作环节都比传统手工记录方式节省时间,在多个方面显示出了明显的优势。结论在临床试验中采用电子信息化管理模式更有利于试验操作的规范性、及时性,并且提高药物临床试验的效率与质量。
Objective To introduce a new mode of whole-process electronic information management in drug clinical trials and improve the efficiency of clinical trials.Methods According to the clinical trial operation process,the functional characteristics and advantages of the clinical trial information platform were analyzed,and the management effect between the traditional manual mode and the new mode was compared.Results The electronic information system saved time as compared with the traditional manual recording method in different operation links and had obvious advantages in many aspects.Conclusion Electronic information management mode in clinical trials helps improve the standardization and timeliness of trial operation,and improve the efficiency and quality of clinical trials.
作者
陈元璐
谢朋飞
崔宏娣
龙辉
赵永刚
张永东
CHEN Yuan-lu;XIE Peng-fei;CUI Hong-di;LONG-Hui;ZHAO Yong-gang;ZHANG Yong-dong(PhaseⅠClinical Trial Centre,Chenzhou First People's Hospital,Chenzhou Hunan 423000;Research Institute of Hospital Management,University of South China,Chenzhou Hunan 423000)
出处
《中南药学》
2023年第9期2519-2524,共6页
Central South Pharmacy
基金
国家卫健委重大新药创制科技重大专项课题(编号:2020ZX09201010)
南华大学医院管理研究所项目(编号:2020YYGL06)
郴州市科技发展计划项目(编号:yfzx201912)
郴州市第一人民医院院级科研项目(编号:N2019-025)。
关键词
临床试验
电子信息化
新模式
clinical trial
electronic informatization
new mode
