trials

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SDTM mapping

SDTM Mapping For Food And Drugs

Study Data Tabulation Model or SDTM for short, is currently the standard format for compiling and submitting the data that is collected during clinical and non clinical studies.  It is a requirement when applying for approval of any new food product or medicinal drug.  These datasets are then submitted to regulatory bodies such as the United States Food and Drug Administration or FDA, who then examine the evidence and make an executive decision as to whether or not it can