[Medical real-world data governance-Construction of common data model]
1Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China.
None:
Real-world data (RWD) governance is a critical foundation for generating high-quality real-world evidence. However, inconsistencies in data structure, terminology, and quality control across different data sources hinder cross-institutional data integration and use. Against this background, the group standard T/CAS 1170-2025, Medical real-world data governance-Construction of common data model, was developed to provide technical specifications for common data model (CDM) construction for medical RWD. This article interprets the drafting background, main contents, and practical significance of the standard. The standard describes key stages in CDM development, including requirement analysis and data source definition, data model design, terminology standardization and mapping, data integration, model validation and quality assessment, as well as model maintenance and evolution. It also puts forward requirements for data security and compliance, data transparency, bias control, and reproducibility of analytical results. In light of domestic and international practice, CDM has gradually become an important technical foundation for standardized RWD governance, collaborative analysis, and evidence generation. Although China has initiated relevant explorations at the levels of hospitals, specialty platforms, and regional health information systems, these efforts remain relatively fragmented overall. The release of this standard provides a unified framework for medical RWD governance in China, and is expected to improve data standardization, promote multicenter collaboration and data sharing, and support post-marketing evaluation of drugs and the development of regulatory science.
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