March 6, 2012 | The Clinical Data Interchange Standards Consortium (CDISC) announced a public review and comment period for the new CDISC Device Standards and encouragement for device companies to be involved in CDISC activities. This marks the first development by CDISC of standards for device trials. The draft document contains seven proposed new Study Data Tabulation Model (SDTM) domains that are designed to capture basic information about medical devices for the purpose of streamlining product reviews by the Food and Drug Administration (FDA). These domains have been modeled on and work in concert with existing SDTM constructs. CDISC