Construction and application evaluation of clinical trial quality management system based on artificial intelligence
ZHAO Shi-jie
WANG Ting
ZHENG Jing
WANG Zheng
XIE Meng
LIANG Jing
YU Hang
ZHANG Xu-dong
Abstract：Source data management constitutes the cornerstone of clinical trial quality.By integrating electronic source data technology with Electronic Data Capture(EDC)systems,this study pioneers the incorporation of artificial intelligence(AI)into clinical trial data management and has developed a novel clinical trial management system aimed at enhancing trial efficiency and quality.The system incorporates intelligent data entry,automated quality control,remote monitoring capabilities,and automated subject screening and recruitment functions.A pilot application within a nasopharyngeal carcinoma study demonstrated significant improvements:markedly reduced data processing time,high data accuracy,decreased frequency of on-site monitoring visits,and accelerated patient matching.These findings underscore the key contribution of AI technology to clinical trial quality control and highlight its substantial potential for further refinement and practical implementation.
Keywords：clinical trialsintelligentizationquality control
Publication Date：2026-01-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 11-16 )