the development process and other standards-related activities at FDA. Rhonda Facile and John Owen delivered the traditional CFAST update presentation on CFAST program status and lessons learned, and finally Diane Wold (GSK) and Jon Neville (C-Path) described the mindset change towards concept-based metadata, the value it brings to the Therapeutic Area User Guides, and to CDISC SHARE, and how this has resulted in a drive towards further development of CDISC standards, especially the SDTM. They also highlighted concept mapping and showed how concept mapping can be applied to imaging modalities.


To follow the CFAST status, please refer to the CDISC website under Standards and click on Therapeutic Area Products in the diagram. Clinical Outcome Assessment standards, Questionnaires and Terminology can also be accessed via this diagram.


By Rhonda Facile, CDISC Senior Director, Standards and Development


Strength through Collaboration


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