d Davina


SENDIG 3.1 uses controlled terms for MISTRESC, but the validator isn't flagging non-controlled MISTRESC entries. Is it possible to include this?

Forums: Validation Rule Suggestions

on July 3, 2019

Hi Davina, 

According to SEND IG 3.1, MISTRESC variable is assigned to two different CT codelist.

We are not sure about implementation of this business rule.

Thank you, 


d Davina
on July 5, 2019

Hi Sergiy,

Thank you for your reply. Both of those codelists are extensible, and we have had to extend them. We thought the validator would identify codes that are not in the CT.



j Jozef
on July 5, 2019

As Sergiy indicated, there are two possible codelists for MISTRESC as per SENDIG.
In such a case, the software should look into the define.xml which one is assigned to MISTRESC and than use that for validation. Background of this is that the define.xml is the "sponsor's truth". So you should add the define.xml location to the validator.
If you have terms from both the codelists, I would suggest that you combine them into a new, sponsor-defined codelist, but keep the NCI codes of each term, and assign that codelist to the variable in the define.xml. Of course that codelist could also contain "extended values" (marked by def:ExtendedValue and without NCI code).
The software should then also pick that up.

The CDISC Define-XML development team has discussed this situation with the SEND team. The general consensus is that in the case of multiple codelists, one should separate the cases for which each codelist applies on the define.xml ValueList level. I am however not confident enough in the MI domain to be able to say on basis of what variable one should make this separation (MICAT?).

With best regards,


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