CDISC Technical Update – Recent and Upcoming Accomplishments
Therapeutic Areas: The CFAST Therapeutic Area Standards User Guide (TAUG) for Influenza v1 has now been posted for provisional use.
The CFAST TAUG for QT v1 will be posted for provisional use in December. Coming next are new Draft CFAST TAUGs for Hepatitis-C and Schizophrenia, both expected to be posted for public comment by end of 2014.
Foundational Standards: Comment periods for 3 major new foundational documents will close in early December: o SDTM Implementation Guide: Pharmacogenomics/Genetics v1 (due Dec. 2) o SEND Implementation Guide v3.1 (due Dec. 4) o SDTM Implementation Guide Human Clinical Trials v3.3 Batch 2 (due Dec. 10)
Coming soon will be the final version of the ADaM Analysis Results Metadata Specification v1. Also coming soon is the CDISC Standards in RDF Reference Guide prepared by the PhUSE CSS Semantic Technology group.
SHARE: Additional content continues to be posted to the CDISC eSHARE standards delivery site, including updated terminology (including ADaM and QS/FT) and SDTM metadata for Medical Devices. Initial ADaM metadata is expected to be available by end of year.
Other: An updated CDISC Technical Plan is now available listing new products to be made available for comment and use through 2015. 2015 Team Charters are currently being prepared.
Strength through Collaboration
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