y Y
on

 

Hi there,

We used to put ECOG score in QS domain, and set QSCAT='ECOG'; QSTESTCD='ECOG101'; QSTEST='ECOG1-Performance Status'; This will trigger P21 community warning message since ECOG is not part in QSCAT CT. ECOG is listed in CCCAT CT which is one the the two CTs associated with RSCAT. Lately CDISC suggests to put ECOG into RS domain, and set RSCAT='ECOG'; RSTESTCD='ECOG101'; RSTEST='ECOG1-Performance Status'; But doing so will trigger different kind of warning messages: "RSTESTCD value not found in 'Oncology Response Assessment Test Code' extensible codelist";  "RSSTRESC value not found in 'Oncology Response Assessment Result' extensible codelist".

Both QSCAT CT and ONCRSR CT are extensible though, we can certainly explain in reviewer guide. Just wonder why it even triggers the warning when RSCAT=ECOG, clearly in this case, it should not check against ONCRSR CT.

Thanks,

Ya

Forums: SDTM

j Jozef
on April 18, 2023

These messages "value not found in xxx extensible codelist" are confusing.
If you extend a codelist that is extensible, you need to do so in the define.xml with the attribute "def:ExtendedValue" set to "Yes". See the Define-XML specification for details.
When you did so, the message essentially should disappear, otherwise it is a software bug. After all, the define.xml is "the sponsor's truth" about the submission.

Jozef Aerts
Define-XML development team and CDISC Define-XML Trainer

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