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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 -126 data value ranges (no UTF-8)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
      local language 

    • 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