Topic 1: News & Updates,

Presenter: Markus Stoll + All

News, Topics, Updates from CDISC US Interchange or the community:

    • New FDA TCG (Tehcnical Conformance Guide) update end of Oct 2022
      Update section in the new document (v5.0) was presented and discussed

    • No team members participated on US Interchange - therefore no updates from there

Topic 2:  Next Face-2-Face Meeting - planning for 2023

Location: Mainanalytics in Sulzbach (Taunus) 

Topic 3:  Technical Information Sessions - Meeting Series in 2023 

Presenter: Markus 

    • Idea to start with a new "technical information session" series in 2023.  Focus: technical topics of interest (tools, techniques, others) can be shared among the usergroup team members in 30 minute presentation slots (proposed timeframe) in our regular monthly TC's. 

    • Markus proposed to start with topics from the CDISC COSA (Open Source Alliance Initiative) and to initiative a poll among the UG members to select the most popular topics.
    • Markus also asked for any additional topics in case there are any ideas among the team members.
    • Decision: All agreed to start with the poll

Post Meeting Note:  Link to Poll -


Topic 4:  AoB

Question/Query: How to handle special characters in cases of data in local language or exceeding length issues (>200 chars) in XPT files 

    • XPT files only supports single byte character sets with an encoding in ASCII 32-126 (printable ASCII character range). This does not support  languages which requires a double or multiple byte characters set (as Japanese, Chinese etc.)
      • Recommendation:
        Submissions to FDA: require anyway translation into english language which is supported in XPT format (CAVEAT: Special characters beyond ASCII126 as eg. ©, ®, ½ or ± require a transition into a value or textual description within ASCII32-126 range. This could also lead to more than 200chars if the values collected are just below or equal to 200chars, but contain such special characters). Local language value mapping (translations) could be provided either in cSDRG, as additional supportive documents and also in metadata file (define.xml). Approach could be queried with FDA eData Team. 
        Submission to other (non-FDA) authorities: it should be disucssed whether additional datasets in non-XPT format could be provided (in addition or in general) to support data submission in local language.
      • values exceeding 200 chars need to splitted according to official manual in SDTM-IG

    • define-xml v2.1 implementation: Does anyone have already experience with the implementation of the define version 2.1 which becomes a requirement for new studies in March 2023? 
      • None of the participants could provide feedback on this topic.

Next regular Meeting: Dec.-16th 


Next regular Meeting scheduled for Dec - 16th 

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