Kidney Transplant Therapeutic Area User Guide v1.0
Version 1.0 of the Kidney Transplant Therapeutic Area Data Standard (TAUG-KT) was developed under the CFAST program and the CDISC Standards Development Process. The TA User Guide-KT describes the most common biomedical concepts relevant to Kidney Transplant, and the necessary metadata to represent such data consistent with CDISC standards, including the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM).
We post the Public Review comments to ensure transparency and show implementers how these comments were addressed in the standard development process.
TA Specifications summarize how to adapt implementation approaches in the TAUG when creating datasets based on different versions of the SDTM. The specifications comprise five worksheets in an Excel workbook:
- Read Me – Information on how to read the other worksheets
- Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
- Known Issues – A list of modeling issues noted in the TAUG
- Domains – Domains used and their status in different versions of the SDTMIG
- Variables – Variables used and their status in different versions of the SDTM