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SDTM Implementation Guide for Medical Devices 

 

The Study Data Tabulation Model Guide for Medical Devices (SDTMIG-MD) v.1.0 defines recommended standards for the submission of data from clinical trials in which medical devices are used. The document includes seven new domains, developed by a team comprised of medical device experts, CDISC experts, and the FDA (CDRH and CBER), and represents years of work by the members of the CDISC Medical Device team. Training on these seven new domains has been incorporated into the standard SDTM training available through CDISC.