Diabetes Therapeutic Area User Guide v1.0 - Supplement for ADaM
Diabetes Therapeutic Area User Guide v1.0
Version 1.0 Provisional of the Diabetes Therapeutic Area User Guide (TAUG-Diabetes), released 2014-09-11, provides guidance on the implementing the Study Data Tabulation Model (SDTM) to represent diabetes data in regulatory submissions. TAUG-Diabetes describes the most common biomedical concepts relevant to diabetes studies, and the necessary metadata to represent such data consistently with CDISC standards.
|Diabetes Therapeutic Area Data Standard User Guide v1||7.55 MB|
|CDISC Diabetes v1 Public Review Comments||78.32 KB|