specify NCI codelist in ADaM Define.xml

Pinnacle 21 Support Define.xml
1

It depends …
Usually, one will develop subset codelists starting from the by CDISC published codelist, containing only the values that one really needs.
This is especially the case for the UNIT (C71620) codelist. After all, the codelists in the define.xml are meant to only contain the POSSIBLE values in your submission.
So, if your list of units in ADCM, ADLB and ADEX are completely identical (which I doubt), you can generate a single UNIT-subset-codelists starting from the by CDISC published one, and reference that single subset-codelist from the corresponding variables in these three domains.
If your list of units in ADCM, ADLB and ADEX are not identical, you should generate 3 subset UNIT codelists, one for each case, take care that your variables reference the correct one.
Please also take into account that these subset codelists still need to contain the correct NCI codes both at the codelist level itself, as on the codelist item level, even though it are subsets, unless for “extended” values, which will have the attribute def:ExtendedValue=“Yes”.

There is a good amount of user-friendly tools available on the market to do all this easily and correctly.

Jozef Aerts
CDISC Define-XML Team

2

In order to specify NCI codelist which is used mulitiple ADaM datasets, there is a rule for the case described below?

For example, NCI Codelist “Unit (Codelist code : C71620)” is used for ADCM, ADLB and ADEX for describing CM dose unit, LB test result unit and EX dose unit in each datasets.
And each values of unit included in each ADaM are different according to the datasets. (ex. ADCM : mg / ADEX : mg/kg, mg/m2 / ADLB : %, AUC etc.)

In this case, should we describe one codelist for three ADaM datasets in define.xml? or should we split three codelist for each ADaM (i.e. CMUNIT, LBUNIT, EXUNIT)?

We guess if the purpose of codelist in ADaM is to show the limited value in each variables, we need to split the codelist for each ADaM.
or if the purpose is to show the decoded value of coded value, it is acceptable to use one combined codelist for multiple ADaM.

So, please let me know which one is closer to your opinion.