CT File Changes (Dec2013-Mar2014)

d Damon

on July 3, 2014

All, I'm wondering if others have found some minor changes to the last 2 recent CT files that may be causing 'false' issues to fire during an OC run. For example, there carriage returns in the Dec2013 and Mar2014 CT files for about 5 or 6 items. One of those items is PK Units for C85494 (unit=min*mmol/L/(kg/m2))Has OC accounted for this or similar issues in the CT files? Another change is the reference for "SDTM Domain Abbreviation" is now "SDTMIG Domain Abbreviation". Is it possible that MedDRA dictionary errors could be surfacing due to this change? Does OC v1.5 account for this?Looking forward to feedback!Damon

Forums: Troubleshooting and Problems

s Sergiy

on July 3, 2014

Hi Damon, Sorry, I could not

Hi Damon,

Sorry, I could not find anything wrong with recent CDISC Terminology files. Your example about PK Unit "min*mmol/..." also looks fine. There is no carriage returns in .txt or .xls files I could identify. More details (e.g., exact CT version, file, codelist and term) will be helpful.

Currently Codelists Names are used only in business rule descriptions, while Codelist Code is utilized in validation algorithms. Therefore we do not expect any impact by new changes in CT Codelist Names.

MedDRA validation is independent from CDISC CT.

We'll be happy to investigate any particular examples with false-positive validation messages, which could be related to inconsistencies between CT versions.

Thank you for sharing your findings and concerns!

Kind Regards,

Sergiy

a Anthony

on July 6, 2014