Topic 1: Questions by Judith Köppert to DACH UG which could not be discussed in this meeting,

Presenter: Judith Köppert

Questions on...

> SV Start/End rules 

> TSVAL parameter Codelists for INDIC and TRT 


> requirement for use of AP Domains

were discussed and resolved.

Topic 2:  Proposed Change of Mailing List (CDISC administrated default group to self-administrated Google Mailgroup),

Presenter: Markus Stoll

Googlegroups CDISC DEUN Mitgliederliste

Hilfe/Info Googlegroups:

Markus proposed to use the Google Mailing Group to replace the current CDISC Mailinglist. Background, there were several cases where mails have not been forwarded to the team. Reasons are unknown as the administration is with the CDISC admins and only vague feedback was provided. Google Groups provides much more functionality as the current mailing list and provides full administration capabilities, including role assignement for users with Google accounts. However, the most important topic is a that a Google account is NOT required to be a member of the mailing list. This allows us to easily switch all currently registered CDISC DEUN mailgroup members to the new google mailgroup.

Decision: It was agreed to switch and test the new mailing list. After 6 months we will rediscuss whether we stay with the new Google Mailgroup list or switch back to the CDISC administrated mailing list. 

Next steps: Markus will hide the registration possibility on the CDISC wiki for the current mailing list and will ask the CDISC admins for a current mailgroup member list. Then he will add all members to the new mailing list and send out an announcement to the usergroup members when all is done.    

Topic 3:  Proposal for Review of SDTM-IG 3.4 - agreement on approach and call for volunteers,

Presenter: Markus Stoll

Markus presented the list of updates in SDTM; v3.4 he so far extracted from the P21 presentation. The list is not complete as there were performance issues with the wiki the day before, but will be completed soon. However, he will publish the current version already in the wiki under...

German Usergroup Wiki > DACH Group Discussions > SDTM-IG 3.3/-Model 1.7 to SDTM-IG 3.4/-Model 2.0 changes...   

Potential volunteers can check here which topic(s) they would like to volunteer.  Volunteers can send a notification to Markus via the email address m[at] or via the (current) team mailing list (deun[at] Assignments will then be updated in the wiki. In the net meeting in March we will discuss this topic again and hopefully assign all topics to volunteers. Additionall important topics on the changes from SDTM-IG v3.3 to v3.4 which are not in the list can also be communicated and added to the list (e.g. changes on SV structure and controversity about new variables for LOINC Support in v3.4). 

Topic 4:  Any other Business,

Discussion: All

AoB - Updates in FDA Data Standards Catalogue

(current Version as of Feb 16th 2022)

Markus pointed out that the new SDTM IG v3.4 is still not listed in the FDA SDSC. So it becomes very unlikely that the FDA support for this version begins before 2023, probably not even before 2024. 

Change History






Data Exchange Standards:
- Added new row for SEND version 1.6, SENDIG-DART v1.1 with the Date Support Begins and Date Requirement Begins
- Footnote 9 added

Terminology Standards:
- Footnote 9 added



Data Exchange Standards:
- Footnote 10 added

Terminology Standards:
- Footnote 10 added



Data Exchange Standard:
- Updated the Date Requirement Begins for SDTM version 1.8, SENDIG-AR v1.0



Data Exchange Standards:
- Footnote 11 added

Terminology Standards:
- Footnote 11 added



Data Exchange Standards:
- Added SENDIG v3.1.1 with the Date Support begins and the Date Requirement begins

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