CT0023 and MULTIPLE

Re: CT0023 and MULTIPLE

Hi Martin,

I agree, term MULTIPLE should be part of the LOC (Anatomical Location) codelist. However, for whatever reason it has not been included in the published SDTM Terminology. The good news is that LOC codelist is extensible, so you can add the term to your codelist in define.xml and Validator will accept it as valid.

You should also file a request with the CDISC Terminology team to add this term in the future: http://ncitermform.nci.nih.gov/?version=cdisc

Thanks,
Max

Hi, thanks for the suggestion

Hi, thanks for the suggestion and the link! However I'm not sure that this is the right approach - MULTIPLE is not a value for a particular codelist, it's a special value that can be used with any non-result qualifier - 4.1.2.8.3 of the implementation guide seems pretty clear on this. It would need to be added to every codelist of this type and given that it is not currently present in any codelist I suspect a deliberate decision has been made not to include it.

It seems to me that it would be more logical to handle it directly in the validator as a special case for non-result qualifiers - what do you think?

Cheers,

Martin

Re: MULTIPLE

Hi Martin,

I think you are probably right, the CDISC Terminology team has excluded MULTIPLE from codelists deliberately. We can easily adjust the CT---- rules to ignore MULTIPLE, however I'm not sure what to do about rule SD0037. This is the rule that validates data against user-defined codelists specified in define.xml. Should sponsors include MULTIPLE in define.xml codelist or not? It's going to be much harder to customize this rule to ignore MUTLIPE for just the non-result qualifier variables. I'll ask around and we'll make the necessary changes in the upcoming release.

Thanks again for your feedback,
Max