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Article Abstract
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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