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

1 Like
2

Hi @a.shtaiwi

We actually have a planned enhancement to adjust a handful of rules for when def:HasNoData is present and populated. DD0124 (Expected Codelist is missing) is one of those rules. We will, one day, update that to not fire when def:HasNoData=“Yes”.

In this case, I think the best practice would be to omit the codelist from that QEVAL variable and describe the finding in your report–explaining that it contains no data and is empty on all observations in the dataset.

I hope this helps!
Trevor