CDISC Technical Update


Work continues on configuring SHARE for the initial release, whichmeans adding team members and moving forward toward a release Q1 2014. In other standards news, Terminology Package 16 has been posted for comment. Final versions of SDTM 1.4/SDTMIG 3.1.4. and the CDASH SAE Addendum are being readied for final posting prior to the International Interchange (4-8 November). The Asthma data standard user guide, the first TA project developed under the new CFAST process, was posted for public review; comments are due 18 October. The Alzheimer’s Disease v2 user guide was posted for public review on October 7th; comments are due on 6 November. A list of updated Questionnaire Documentation, along with Questionnaire Supplements table, was posted in October 2014 (see below for details). Work continues on five other TA projects (see http://www.cdisc.org/therapeutic for more information), and the CFAST Steering Committee is currently prioritizing additional projects for 2014.


CDISC Standards – Recently Posted Updates and Standards Available for Public Review and Comment


Standard Available for Comment


Standards Available for Review and Public Review and Comment Link


Asthma Therapeutic Area Data Standard User Guide v 1.0 (TAUG-Asthma)


Terminology Call for Public Review Package 16


Alzheimer’s Disease Therapeutic Area Data Standard User Guide v 2.0


http://www.cdisc.org/therapeutic http://www.cdisc.org/terminology http://www.cdisc.org/therapeutic Comments due 6 November 2013 Comments Due Date Comments due 18 October 2013 Comments due 25 October 2013


Strength through Collaboration


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