Labels for Suppqual and Custom Domains in xpt files.

Pinnacle 21 General General Discussion
1

Hi Ankur,

Now OpenCDISC does not enforce any requirements for dataset labels because CDISC SDTM standard does not specify dataset labels. It only provides dataset “descriptions”, which are not 100% consistent across the document.

As of today the OpenCDISC tool uses domains descriptions only for reporting purpose, but not for validation. We think that it’s enough to have the same descriptiosn for all SUPPQUAL domains, because our reports also include dataset names.

And yes, you are correct. According to SDTM IG (e.g., 3.1.2 #8.4.1, page 261) accurate descriptions for SUPPQUAL domains should be “Supplemental Qualifiers [DOMAIN NAME]”.

E.g, “Supplemental Qualifiers LB”

As a summary

  1. OpenCDISC does not check dataset labels, because there are no formal requirements or standard specifications on this subject.

  2. I believe that it’s a good practice to use SDTM IG domain descriptions for dataset labels. Be careful and remember that those values can be slightly different across SDTM IG document. Make your choice and use those dataset labels in consistent manner.

  3. My interpretation of IG is that the correct description for a SUPPLB domain should be “Supplemental Qualifiers LB”. However, for example, in the CDISC updated Pilot 1 project data package there are no labels for SUPP—datasets, and the description of a SUPPLB in define file is “Supplemental Qualifiers for LB”.

Thanks for sharing your concerns!

Kind Regards,

Sergiy

2

Thanks for the clairification Sergiy.

3

Great post. I had another thread discussing the variations of dataset labels across SDTM IG, CT and OpenCDISC previously. Personally, our group utilizes “Supplemental Qualifiers for XX”. Sponsor’s have varying ways to represent this since there are no specific standards, except for the CDISC MSG reference example.

4

Dear All,

I have a question regarding appearance of labels for suppqual and custom domain for SDTM xpt files. When I run OpenCDISC on SDTM xpt files, for suppqual domains it shows labels as “Supplemental Qualifier” and for custom domain instead of showing label it shows class as its label such as “Findings”.

I have tried labelling suppqual as “Supplemental Qualifier - LB” and “Supplemental Qualifier [Laboratory Test Results]”. In both case, labels appeared as “Supplemental Qualifier”.

Please advise, if appearance of labels like this is okay in OpenCDISC report or labels should be written in specific manner to fix the issue.

Regards,

Ankur.