c Courntey
on

 

Hi, I am validating domains along side the define.xml. In the define.xml, I added a term to the CMROUTE controlled terminology list since it is extensible. I added the term "OTHER" and included it in the define.xml but when I run the validator with both the domains and define.xml I still get CT0031 that states "Route of Administration (--ROUTE) variables values should be populated with terms found in 'Route of Administration' (C66729) CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.". When I used to use validator version 1.4 it would allow adding values to comtrolled terminology lists with no errors or warnings. Can someone please explain how to avoid the CT0031 message when validating?

 

Thanks,

Courtney

Forums: SDTM

s Sergiy
on September 10, 2014

Hi Courtney, 

If you added a new term in CT you will receive a validation message.

There are two separate set of checks:

1. SD0037 ensures that a codelist in define.xml file describes actual data correctly. This is "metadata" check.

2. CTxxxx checks are about following standard Control Terminology. Any additional terms are reported by the validator and require a manual review for their valid usage. So far we cannot programmatically implement the following business rule: "New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.

Therefore the only way to avoid CTxxxx messages is to 100% follow standard CT.

It's OK! to introduce new terms for extensible CT. However you need to document and explain it.

Kind Regards, 

Sergiy

c Courntey
on September 10, 2014

Great! thank you very much!!

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