DD0055

According to page 4 of http://cdisc.org/system/files/members/standard/adam/ADaM%20OCCDS%20v1Provisional.pdf

you should use this for the Class

ADaM 1.0 IG – ADAE

ADaM 1.1 IG – OCCURRENCE DATA STRUCTURE

Of course, NCI does not have ADAE in its GNRLOBSC codelist. According to ALT (adam leadership team) and ADaM Validation subteam, you should use ADAE. And since you can’t possibly be using ADaM 1.1 since it has not been released, i would go with ADAE. Interested in your take on this.



EVENTS



C103372



FINDINGS



C103373



INTERVENTIONS



C103374



RELATIONSHIP



C103376



SPECIAL PURPOSE



C103377



TRIAL DESIGN



C103379



SUBJECT LEVEL ANALYSIS DATASET



C103378



BASIC DATA STRUCTURE



C103371



OCCURRENCE DATA STRUCTURE



C123454

The Define-XML specification rules that def:Class needs to follow the NCI GNRLOBSC codelist. ADAE was indeed never part of the GNRLOBSC CodeList.

So, I still think we have to follow whatever is in the GNRLOBSC CodeList.
Note that the Analysis Metadata Results example as published by CDISC also uses OCCURRENCE DATA STRUCTURE.

This is all about Define-XML v2 of course, as in Define-XML v1 this was not strictly defined. The older document (ADaM IG 1.0) were published before the release of Dfine-XML v2.

Be aware that more Define-XML metadata will be driven by NCI Codelists in Define-XML 2.1 (eg. Origin), so can not be hardcoded in the application.

I hear you. We will account for the lastest terminology coming soon so that define.xml issues are corrected. However if you plan on using a Define.xml for ADaM, the ALT and OCCDS documentation is very clear that you should use ADAE with ADaM 2.1/IG 1.0.

I don’t see why you have to use ADAE, but i’m also not very passionate about issues dealing with labels or categories that do not really impact regulatory review. i.e. ADAE vs OCCDS or …Standard unit vs Std. Unit. Sometimes we don’t give humans sometimes enough credit to deciper on their own :slight_smile:

It looks like the ItemGroupDef/def:Class values are hard-coded, since “OCCURRENCE DATA STRUCTURE” for ADaM is deemed invalid (ERROR). However, the values are governed by CDISC/NCI CodeList C103329 (GNRLOBSC, “General Observation Class”). “OCCURRENCE DATA STRUCTURE” has been part of the CodeList since 2015-09.

Thanks,
Lex Jansen