Issue: Terminology set is invalid

h Hajime

on October 28, 2016

Following file is invalid. Please update the file

Pinnacle 21 Community version 2.2.0
SDTM Terminology.odm.xml for 2016-03-27

The content of the file is created from CDISC terminology of 2015-03-27 (please see the year. This is 2015 !). Furthermore, there is no SDTM terminology of 2016-03-27. The official release date is 2016-03-25.

Forums: Troubleshooting and Problems

b Brian

on December 1, 2016

As a work-around you can…

As a work-around you can just copy the 2016-03-25 folder from the 2.1.3 release into 2.2

j Jozef

on December 1, 2016

Terminology set is invalid

Also see: https://www.pinnacle21.net/forum/wrong-ct-version-implemented-beatsmin-unit
where this issue has been answered (but not resolved -> next release).
Of course you could replace the file, but how can we be sure that the FDA did the same? I currently have a customer where this seems to be a showstopper, as they get a lot of false positives.