Exploration and reflection on building an intelligent quality control system for electronic medical records in clinical trials
10.3760/cma.j.cn113565-20250408-00095
- VernacularTitle:构建智能化临床试验电子病历质控体系的探索与思考
- Author:
Yang ZHANG
1
;
Sicong GAO
1
;
Xiaohong HAN
1
Author Information
1. 中国医学科学院北京协和医院，北京 100730
- Publication Type:Journal Article
- Keywords:
Clinical trials;
Electronic medical record (EMR);
Intelligent quality control;
Quality control system
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):436-441
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To summarize the practical experience of constructing an intelligent quality control system for electronic medical record (EMR) in clinical trials, providing reference for continuously improving the quality of clinical trials.Methods:Quality control rules for clinical trial EMR were established, and an intelligent quality control platform was developed to enable dynamic monitoring, interception, early warning, and evaluation. A hybrid quality control system integrating real-time and terminal quality control was constructed, alongside a three-dimensional linkage mechanism encompassing training, quality control, and evaluation.Results:Through the extensive application of information technology and the implementation of a multi-level quality control network, a quality control loop characterized by ″Efficient machine screening and precise human decision-making″ was achieved to enhance management quality and efficiency. However, challenges such as the standardization of quality control rules, data security and privacy protection, and system interface heterogeneity were persistent.Conclusions:The development of an intelligent quality control system for clinical trial EMR represents a critical step in advancing clinical trial quality management. Nevertheless, ongoing optimization of technical solutions is essential to address existing challenges and further improve system performance.
