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

Carey G. Smoak, DataCeutics, Inc.


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. Therapeutic Area User Guides (TAUGs) have been a recent focus to provide advice, example and explanations for collecting and submitting data for a specific disease. Non-subjects even have a way to collect data using the Associated Persons Implementation Guide (APIG). SDTM domains for medical device were published 2012. Interestingly, the use of device domains in the TAUGs occurs in fourteen out of eighteen of TAUGs providing examples of the use of various device domains. Drug-device studies also provide a contrast on adoption of CDISC standard for drug submissions versus device submissions. Adoption of SDTM in general and the seven device SDTM domains by the medical device industry has been slow. Reasons for the slow adoption will be discussed in this paper.