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

Purpose

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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