Version 1.0 of the Pediatrics User Guide focuses on cross-cutting clinical concepts related to pediatric research and describes how to use CDISC Standards to collect and structure data used in clinical trials to facilitate the aggregation of information, take advantage of big data and support data sharing. A team consisting of CDISC standards experts, pediatric clinical research experts from CDISC Member organizations and pediatric subject matter experts from the c4c consortium developed the User Guide following CDISC’s consensus-based, standards development process. User Guide Topics include participant and participants’ family information (e.g., medical conditions, reproductive, diet and nutrition, body system assessments), pregnancy and birth, study conduct.
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.
TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2
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