Automating SDTM for Clinical Trial Data Submissions Using Artificial Intelligence and Machine Learning

Jun 29, 2023 | Publications and Posters


SDTM, or Study Data Tabulation Model, is one of the required standards for data submission to the US Food & Drug Administration (FDA). Manually mapping data fields from a clinical trial database to their corresponding SDTM fields has increased statistical programming resources on a clinical trial by approximately 20%. Automating this process through artificial intelligence (AI) aims to reduce the increased time and resources required to format high-quality, CDISC-compliant data for FDA submission.


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