The CFAST diabetes development team, operating within the CDISC consortium, is pleased to announce the availability of the Diabetes Therapeutic Area User Guide (TAUG) v1.0 Draft Data Standard for a 30-day public review. Comments on the guide are due by May 12th.
CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
The Diabetes TAUG v1.0 describes the most common clinical concepts relevant to studies in diabetes, and shows examples of how these concepts are represented in the CDISC study data tabulation model (SDTM). Representations of annotated CDASH-compliant example CRFs and associated metadata for some concepts are included. In addition, this document shows an example set of concept metadata displays as they may be represented in SHARE. Draft domains for Procedure Agents (AG) and Meal Data (ML), as well as a proposal for a disease milestones approach (SM and TM) are also included for review.