Question: Can I include a codelist in Define.xml for an empty variable that wasn’t collected in the CRF?

Pinnacle 21 Support Define.xml
1

Hi everyone,

I have a quick question I hope someone can help me about it!

In my SDTM dataset, I have a variable (e.g., QEVAL) that:

  • Is included in the dataset structure (it appears as a column),
  • Has all null values (no data populated),
  • But it does have a CDISC-controlled terminology codelist (like EVAL).

So here’s what I’m wondering:

  1. Is it okay to include a CodeListRef for this variable in the Define.xml file even if:
  • there’s no data for it, and
  • it wasn’t collected via the CRF?
  1. Could including it this way trigger any validation issues in Pinnacle 21 or cause confusion during review?
  2. Would it be better to:
  • a) Include the variable and reference the CDISC codelist to keep the metadata complete, or
  • b) Leave the codelist (or even the variable) out since it’s not populated or CRF-based?
  1. Does it make a difference that the codelist is CDISC CT only and not based on planned CRF entries?
    I want to avoid the following warning: :DD0124 : Expected Codelist is missing"

Thanks a lot in advance