k Kirsten
on

 

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

Forums: SDTM

s Sergiy
on June 27, 2018

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 

 

j Jozef
on June 28, 2018

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

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