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Topics:

  • Any News&Rumors from the CDISC Community
  • Upcoming Updates/New Releases by end of November

> A bunch of new releases are epxtec for ADaM and SDTM by end of November. If all open topics are clarified by then the new SDTM-IG 3.4 might be released as well.

> On latest conferences (CDISC IC USA and also EU Connect) news of a pilot project were reported which is about sending raw submission data to the EMA. More infos in the presentations provided by Angela Remy from the EU-Connect, Nov-15th:

     Submission of RAW data to EMA.pdf

     Transforming Global Data Exchange.pdf


  • Topics for next Meetings

   > In a discussion about How to read-out aCRF annotations as a source for define.xml specifications Hans-Peter Schnitzer volunteered to present his self developed tool where he has implemented such a functionality in our regular monthly TC in January 2022  

   > As a new version of the Study Technical Conformance Guide was published in October we asked for a volunteer to present any updates/changes to the rpevious version. Petra will reach out to Marion Friebel to ask whether she would volunteer for our last regular TC in 2021 on Dec 17th.   




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