DD0031 (missing NCI code) for TSVALNF

i igor

on May 20, 2019

Dear Team,

Could you please explain the reason DD0031 fires for TSVALNF variable when I validate SDTM define.xml? As per the error Pinnacle21 v3.0.0 expects NCI code C117459 for Null Flavor codelist, but Null Flavor codelist does not exist in CDISC SDTM controlled terminology, and C117459 is the code of TSVALNF variable itself as per the NCI Term Browser.
Why this codelist was added into the CT version Pinnacle21 uses for validation and how people who create define.xml should know of this?

Thanks,

Igor

Forums: Define.xml

i igor

on June 13, 2019

DD0031 (missing NCI code) for TSVALNF

Does anybody know the answer? Where I can find correct NCI codes for Null Flovour codelist?

j Jozef

on June 16, 2019

C117459

There has been a time that null flavor values were added to CDISC-CT, and then were removed again, probably as CDISC is not the "owner" of this list (it comes from HL7). So depending on which version of CT you have been using, there will be an NCI code for them or not. Might however be puzzling to find out when null flavors were added to CDISC-CT and when removed again ...
If you use a CT version (one of the newer) that does NOT have the null flavors, then the best way is to declare the whole "null flavor" codelist as an "ExternalCodeList" (see the define.xml specification for details). The second possibility is to define YOUR OWN codelist with null flavors, so WITHOUT any NCI codes at all. In both cases you then need to assign the codelist to your variable, either at the variable level or on the valuelist level (see the define.xml specification once again).
If you do one of both of these, and you still get an error, then it is definitely a "false positive".

With best regards,

Jozef Aerts
CDISC Define-XML development team