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P21 SDTM terminology not aligned with NCI
It was modified for validation needs
Hi Kristen,
This attribute for (RACE) codelist was modified for validation needs.
Validation messages for CDISC non-extensible CT are Errors, while those are Warnings for extensible CT. There are several exceptions.
Almost all studies have subjects with Race which does not fit existing CDISC (RACE) non-extensible CT. For example, 'MULTIPLE' , 'UNKNOWN' or 'OTHER'. Validation messages for (RACE) CT are expected to be reported as Warnings rather than Errors. Another similar case is (ETHNIC) CT.
Regards,
Sergiy
P21 SDTM terminology not aligned with NCI
The issue here is that the CDISC-CT team decided that the RACE codelist may only contain values that are "real" races (whenever that exists - "race" is not scienctific). So they decided that "MULTIPLE" and "OTHER" do not go into the list as e.g. "MULTIPLE" is not a race. The SDTM-IG however states that also "MULTIPLE" is allowed.
Other organizations like HL7 have the better approach that a codelist is the list of ALL allowed values for a term, with less emphasis on whether the semantics is 100% right.
The CDISC-CT approach is at least questionable, as it makes the codelist not very well usable in software: either one must than hardcode in the software that "MULTIPLE" is allowed although it does not appear in the non-extensible codelist, OR one has to change the codelist type from non-extensible to extensible.
Pinnacle21 choose for the second solution.
Also remark that "warning" in Pinnacle21 means that something is less usual, not that it is wrong.
Personally, I consider this as a serious design error of the CDISC-CT team.
With best regards,
Jozef Aerts
XML4Pharma
I have downloaded the SDTM terminology from your website: https://www.pinnacle21.com/downloads/cdisc-terminology (latest 2018-03-30) and noticed that RACE codelist has
<CodeList OID="CL.C74457.RACE" Name="Race" DataType="text" nciodm:CodeListExtensible="Yes">
but in NCI RACE is specified as
<CodeList OID="CL.C74457.RACE" Name="Race" DataType="text" nciodm:ExtCodeID="C74457" nciodm:CodeListExtensible="No">
It is also the case for other versions.
Any particular reason for this difference? Why have you put the RACE codelist as Extensible?
br Kirsten