b Brian
on

 

Hi,

I was validating some SDTM domains, and noticed some QSTESTCDs that were used, but do NOT belong to the codelist.  In this case, the QSCAT = "C-SSRS SCREENING" and the QSTESTCD = "CSS0901B"...which is not correct.  I was confused since Pinnacle did not raise an error here, based on CT = 2017-12-22.

As a test, I ran these data against the 2015-09-25 CT (when the QS-FT was a separate file), and Pinnacle did give me the CT2004 error.  

I took a look at the XML files for the controlled terminology for 2017-12-22, and the Where Clause seems to be looking for "QSCAT = 'CSS09'" rather than "C-SSRS SCREENING".  I thought that CSS09 was just the synonym for this questionnaire category, not the submission value.  Or perhaps I am not looking at this correctly at all.  In any case, should I expect a CT2004 error to be raised?

Forums: Troubleshooting and Problems

b Brian
on August 16, 2018

As a test in the "SDTM Terminology.odm.xml" file, I changed:

<def:WhereClauseDef OID="WC.QSCAT EQ CSS09">
            <RangeCheck SoftHard="Soft" def:ItemOID="IT.QS.QSCAT" Comparator="EQ">
               <CheckValue>CSS09</CheckValue>
            </RangeCheck>
         </def:WhereClauseDef>

To:

<def:WhereClauseDef OID="WC.QSCAT EQ CSS09">
            <RangeCheck SoftHard="Soft" def:ItemOID="IT.QS.QSCAT" Comparator="EQ">
               <CheckValue>C-SSRS SCREENING</CheckValue>
            </RangeCheck>
         </def:WhereClauseDef>

 

And now I am getting CT2004 errors as I expected.  The CT from CDISC has  QSCAT = C-SSRS SCREENING, so I do not think that is the issue.

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