P21 2.1 issue: DD0031 Missing NCI Code for Codelist 'CL.AESEVN'

f Frans

on December 30, 2015

In ADaM frequently numeric equivalents for NCI codelists are used (e.g. 1=MILD, 2=MODERATE etc.). We use to give them the name from the NCI codelist with addition of "(N)" (e.g. "Severity/Intensity Scale for Adverse Events (N)"). The validator is programmed to treat NCI codelist names with a small extension like "No Yes Response - subset Y" as a valid NCI codelist where NCI code is required. Would it be a good idea to exclude numeric codelists from this rule check to avoid false DD0031?

Thanks,

Frans Sollie - PRA Health Sciences

Forums: Define.xml

j Jozef

on December 31, 2015

Missing NCI code

In my humble opinion, the implementation of this rule in P21 is the world upside down:
The define.xml file is the sponsor's "truth", i.e. it is the sponsor's explanation to the regulatory authorities about what is in your submission data. Adding an NCI code to a codelist item is the sponsor's indication that the term is one from the CDISC controlled terminology. The absence of the NCI code however means ... nothing. One can have a codelist that has the same "name", but with codes that are different from the ones from CDISC. In that case, the codelist items should of course not have an NCI code. It might even be that in such a codelist, some codes are equal to similar codes in CDISC-CT and some are not. But as no NCI code is present, it then is not CDISC-CT, it is a sponsor's defined codelist.
With other words: a validation engine should not rely on what is in the "Name" attribute of the codelist to find out whether the codelist is from CDISC-CT. The NCI codes themselves are the only identifiers for this.

My suggestion is that the implementation of the rule is changed as follows (for define.xml 2.0):
- if a single item in the codelist has an NCI code, then all other items in the codelist must either have an NCI code OR must have the attribute def:ExtendedValue="Yes".
Essentially, this is a consistency check.

Jozef Aerts - Define-XML Development Team