Automated testing improves data quality and reduces validation time in clinical research databases, highlighting the importance of reliable metadata.
Reliable and interoperable clinical research data is important for medical research. We have developed ODM-AutoAssess, a web-app that automates the validation of CDISC ODM metadata. It parses ODM XML, detects structural and logical errors, generates test cases, and simulates user interactions in EDC systems. Real-world evaluations have proven that it reduces validation time by over 70% and improves the detection of metadata inconsistencies. Results are shown in interactive, exportable summaries. The tool supports metadata quality and clinical research.
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Hussein et al. (2025) studied this question.
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