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In SDTM define.xml, if multiple decoded values(display values) exist, how to generate codelist in define.xml?
Thank you for your help.
Do you mean "decode" values in different languages? That can of course be valuable during the development of a define.xml when you want to do submissions to different regular authorities in different languages. Good Define-XML generating tools allow you to do this. If you don't have such (worst case), you can always do that manually, but that is of course a lot of work.
Also remark that multiple decodes in the same language for a single variable is not allowed in define.xml - the value of "xml:lang" must be unique within "Decode".
If you really want to have multiple decodes in the same language, can you explain (e.g. with an example), why you would like to do this?
Thank you for the reply. I want to add multiple decodes in the same language for single variable. But, as you know, it is not allowed due to OD0079 rule ID.
And, for example, if "Abnormal CS" or "Abnormal NCS" was selected in CRF, I mapped it to the EGSTRESC variable as "ABNORMAL". Since SDTM was created corresponding to the SDTM IG V3.2 and EGSTRESC has a codelist according to the SDTM IG V3.2, decoded value is required. Do you have any idea to map multiple decodes ? (E.g. using Comparator.)
I think I am starting to understand your issue...
First of all, different decodes for the same language are not allowed, as this is a rule in the Define-XML specification itself, so a CDISC rule.
Personal opinion: for mapping from CRF to CDISC codelist, NEVER, NEVER map back to a CDISC codelist value when this means information loss (which seems to be your case). Much better is to extend the codelist with the terms you need, also when this is an -STRESC codelist.
So, if you have two tickboxes "Abnormal CS" and "Abnormal NCS" on your CRF, you should include both these into your codelist for EGORRES, and also for EGSTRESC.
If these are not in the original CDISC codelist, you should mark them with def:ExtendedValue="Yes" in the codelists in the define.xml.
It would be interesting to see your CRF ...
P.S. "Comparator" is for use in ValueLists, e.g. when there are different codelists used depending on the value of e.g. EGCAT or even EGTESTCD.
The codelist you refer to was designed for specific EG tests rather than for all character values of EGSRESC variable in general. Unfortunately, CDISC does not specify this value-level metadata. So, I would recommend you to utilize this codelist as a potentially useful reference rather than a formal requirement.
Many thank you for your suggestion.
We're eager to share and ready to listen.
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