CDISC/NCIt Controlled Terminology from Q'4 2015

j Jon

on January 12, 2016

While looking to download the Controlled Terminology files released in Dec 2015, I found the following note...

----------------------

Questionnaires, Ratings, and Scales (QRS) Terminology:

Keeping the QRS codelists separate from the SDTM codelists was a decision based on the limits of excel spreadsheets. This decision has been reversed, and we will be merging the QRS codelists into the SDTM publication on 2015-12-18. The only content change will be in the codelist long name. Currently the long name starts with QS-, or FT-, or CC-. This prefix will be removed from the codelist long name only.

------------------------

This means there is no longer a QRS file. Will the lack of this file cause the application to crash for either the OpenCDISC Validator v1.x of OPenCDISC Community v2.x? [Yes -- we still have a couple of projects using the old v1.x version of the application].

If the application will crash without this file, would creating a zero byte file for QRS avoid a crash?

Thanks!

Forums: General Discussion

s Sergiy

on January 28, 2016

Hi Jon, We do not support

Hi Jon,

We do not support previous versions of Validator and strongly recommend to use only the most recent version.

There are no valid excuses for usage of outdated validation checks. FDA will judge you based on existence of actual data issues and you are responsible for data quality. Pinnacle 21 (a.k.a OpenCDISC) Validator is a help for you, but FDA expects also running additional all applicable checks to ensure high data quality.

v1.xx will definitely NOT work with new format of CDISC CT.

v2.xx requires CT files from Validator installation package or Automatic Updates.

Kind Regards,

Sergiy