m Manolya
on

 

Hi all,

 

does anyone know how to handle different TESTCD codelists in define.xml without getting P21 issues? For example, we can have several different codelists for QSTESTCD as per cdisc CT depending on questionnaires. In Order to define them I would need to remove the codelist “QSTESTCD” on variable level. How do I put the information in VLM and codelists tab? Or do we still create one QSTESTCD codelist and put all values in there? 
 

Best

Manolya

Forums: Define.xml

j Jozef
on July 15, 2024

For Questionnaires, you would typically have different "ItemGroupDef" instances, each with different OIDs for each of your QSTESTCD, QSTEST, QSORRES, QSCAT, ... QSDTC and so on. If you do so, you don't need VLMs, as all your metadata is coupled to the OIDs (including references to the codelists), not to the variable names.
How you do this in P21 I don't know, I am used to used user-friendly, GUI-based software where the user is in control of the OIDs.<

Alternatively, but I would not recommend this, you can use VLMs, where you use "where clauses" based on QSCAT, as QSCAT typically is the identifier of the questionnaire.
My personal opinion is that this is much more confusing for the reviewer though.

I always regard each instance of a Questionnaire as if it were a separate domain - so NOT as being "splitted" (as one never "splits" anything).

Matt
on July 15, 2024

Hi Manolya,

 

Are you getting issues in Enterprise? If so, I can create an Enterprise Service Desk ticket on your behalf. What issues are you getting regarding this? 

 

Kind regards,

Matt

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