中国食品药品监管Issue(3)：84-93,10.DOI:10.3969/j.issn.1673-5390.2026.03.008
基于风险管理理念设计临床试验数据进展报告
Design and Optimization of a Risk-Based Clinical Trial Data Progress Report
摘要
Abstract
With the rapid growth in the volume of clinical trial data,data science professionals face increasing challenges in efficiently cleaning and reviewing clinical trial datasets.This paper presents the design of a risk-based clinical data management progress report.Based on two key dimensions(data quality and maturity),the proposed approach performs both qualitative and quantitative analyses of risks in data management and incorporates a statistical analysis module to construct a multidimensional risk assessment matrix.The framework aims to improve the efficiency of data cleaning and review,assist research teams in promptly identifying specific data trends and potential monitoring risks,and ultimately support the optimization of clinical strategies.关键词
临床数据管理/数据进展报告/基于风险的数据质量监查/机器学习/数据分析Key words
clinical data management/data management progress report/risk-based data monitoring/machine learning/data analysis分类
医药卫生引用本文复制引用
李蹊,缪亚东,高坡,王燕,周敏,杨涛,李高扬..基于风险管理理念设计临床试验数据进展报告[J].中国食品药品监管,2026,(3):84-93,10.基金项目
国家自然科学基金(81773554) （81773554）
