CT2002 - LBORRESU value not found in 'Unit' extensible codelist when incorporating define.xml

CT2002 vs SD0037

The idea is that CT2002 will always get triggered just so the FDA knows you've extended it (either in data only, or both data and define.xml).  SD0037 would then fire if you don't include the value in your define.xml.  If there is no issue for SD0037 for this variable, then it would appear you placed the term in the Define.xml codelist appropriately.

Of course, even if you extend it correctly in your define.xml, when it hits a regulatory review, human eyes like myself may determine that you extended a codelist with a synonym of a value already present.  In that case, the WARNING would be implicity upgraded to an ERROR.   If the extended value is truely unique/value add/protocol specific, then implicity a person decides the WARNING downgrades to an INFO.

As sofware and term matching becomes increasingly sophisticated and reliable, the person could be replaced by a machine :)

Thanks!

Thanks - that answered my question perfectly!  

Thanks!

Thanks - you answered my question perfectly! 

Extensible codelist

The define.xml v.2.0 specification states (4.3. Controlled Terminology Definitions): "If a Define-XML CodeList element includes definitions of terms that are not included in the published list, then the def:ExtendedValue attribute should be set to “Yes” (on CodeListItem or EnumeratedItem) regardless of whether or not the codelist is extensible".

The def:Extended attribute has exactly been designed to let the reviewer know that the codelist has been extended with that specific value or code. So if you correctly added the attribute, AND the codelist is "extensible", none of the rules CT2002 nor SD0037 should trigger, as there is no violation AND the reviewer already knows about the extended value from the define.xml (his/her first source of information).

Didn't you (agarrett) forget to add the def:ExtendedValue="Yes" to the "EnumeratedItem" or "CodeListItem"?

Extensible CodeList

I think what Mike is pointing at, is this fragment from the Define-XML specification 4.3: Sponsors may add to extensible codelists as long as they are not adding duplicates or synonyms of existing terms.

Unfortunately a computer would not be able to check thuis violation.

More importantly to Joseph's

More importantly to Joseph's concern, Pinnacle 21 Community automatically sets the extended atribute flag (def:ExtendedValue="Yes") for a codelist that has extended terms.   Amy, if you use Community Define generator, you will get that for free.   The extended codelists i believe are shown with an asterisk in the Browser via the style sheet.