Version 1.1 of the Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD v1.1) defines data standards for medical device-related data in clinical research. SDTMIG-MD v1.1 covers devices under investigation as well as ancillary devices in non-device trials, and is appropriate for regulatory submission and non-submission studies. The standards include core data that are shared by most devices, providing guidance and examples on organizing, structuring and formatting device datasets. SDTMIG-MD v1.1 is the finalized version of the provisional v1.0, and the primary changes are confirming the finalization of variables that were proposed in version 1.0, and removing language suggesting that Device Identifiers was an optional domain.
SDTMIG for Medical Devices v1.0 defines recommended standards for submitting data from clinical trials when medical devices are used. The document includes seven additional domains, developed by a team composed of medical device experts, CDISC specialists, and the FDA (CDRH and CBER).