CDASH Model v1.2 provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model. CDASH Model v1.2 provides root-naming conventions for CDASHIG variables, intended to facilitate mapping to SDTMIG variables. The CDASH Model is compatible with, and structured similarly, to the SDTM v1.7.
The most significant changes from the previous versions include the addition of new SDTMIG v3.3 domains (i.e., AG, ML, OE, RE) as well as updated CDASH Model and CDASHIG variable labels where needed to align more closely with SDTMIG and SDTM.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.