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A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices Abstract

A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices Abstract

The Clinical Data Interchange Standards Consortium (CDISC) encompasses a variety of standards for medical research. Amongst the several standards developed by the CDISC organization are standards for data collection (Clinical Data Acquisition Standard Harmonization - CDASH), data submission (Study Data Tabulation Model - SDTM) and data analysis (Analysis Data Model - ADaM). These standards were originally developed with drug development in mind.