DD0060 Define.xml/CDISC variable Label mismatch (IE.IETESTCD)

k Kunihito

on December 12, 2015

Pinnacle21 Community v2.1 picks up the follwing error when I validate my define.xml v2.0, but I think this is a false-positive.

IT.IE.IETESTCD,Inclusion/Exclusion Criterion Short Name,Incl/Excl Criterion Short Name

I believe the label of IE.IETESTCD has always been "Inclusion/Exclusion Criterion Short Name". Not really sure how the software recognizes "Incl/Excl Criterion Short Name" is the cdisc-defined label, but I noticed that TI.IETESTCD is configured such way in the SDTM 3.1.3 config, which might be relevant with this issue.

Forums: Define.xml

g Gerard

on December 14, 2015

Hey Ebi, Youare correct

Hey Ebi,

You are correct about the variable label mismatch. The SDTM 3.1.3 IG specifies the label for IETESTCD as “Inclusion/Exclusion Criterion Short Name”. You can treat this as a false positive for now, we will be releasing an update before Christmas that fixes this issue. Thanks for reporting the issue.

Regards,

Gerard