Possible False Positives in Define.xml validation

s Sarah

on May 30, 2017

I have validated my SDTM define.xml using the Community version 2.1.3 with the configuration DEFINE (PMDA) and the CDISC SDTM CT version 2015-09-25.

I get the warning: DD0029 (Required attribute def:ExtendedValue is missing or empty this is relating to 'Category of Questionnaire'), and the errors: DD031 (Missing NCI Code for Codelist 'Category of Questionnaire'), and DD032 (Missing NCI Code for Term in Codelist 'Category of Questionnaire'). These warnings and errors appear to be linked to the QSCAT domain.

When I run the validation on the xpt files and include the define.xml, using the configuration SDTM v3.1.3 and CDISC SDTM CT version 2015-09-25, I do not see these warnings and errors. Also, in the CT 2015-09-25, the Codelist 'Category of Questionnaire' does not exist.

Are these false-positive findings? I am unsure how these can generate warnings and errors when the Codelist is not present in the version of the CT I am using.

Has anyone experienced a similar issue?

Thank you.

Sarah

Forums: Define.xml

j Jozef

on May 30, 2017

ExtendedValue

I cannot see your XML, but I can explain the rule, as it was defined by the Define-XML team (which I am part of).
If the codelist that is used has been published by CDISC, each of the items in the list MUST either:
- have the NCI code included (using the "Alias") element (for the items defined by CDISC)
- OR have def:ExtendedValue="Yes" (for the items that you, as a user, have added)

In case the codelist was NOT published by CDISC (for the specific CT version that you use), none of the items should have an NCI code, and none of the items should have def:ExtendedValue="Yes".
This may the case when you use CT version 2015-09-25, as you state that "category of questionnaire" is not defined in that version. So essentially, your codelist would then be a "user defined codelist".

In my (personal) opinion, SDTM validation should always be done with inclusion of the define.xml file, as the define.xml is "the sponsor's truth". I do however also know that Pinnacle21 has another opinion on that.

s Sarah

on May 30, 2017

ExtendedValue

Thanks. I shall take a look into that.

I use Pinnacle 21 Enterprise to generate the define.xml for these SDTMs.

I only get these warning and errors when the define.xml is validated in the Pinnacle 21 Community version 2.1.3 on its own, that is without the xpt files included in the validation. Also, I do not get these when I validate the define package using Pinnacle 21 Enterprise.