CT File Changes (Dec2013-Mar2014)

Pinnacle 21 Support Troubleshooting and Problems
1

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

2

Actually, I found linefeed character for the codelist code Damon pointed out (i.e., C111264).

Filename: SDTM Terminology 2013-12-20.txt
Lines: 5961-2
Column: Submission Value

Other instances are:

NCI EVS code: C112326
Lines: 2438-9
Column: CDSIC Synonym(s)

NCI EVS code: C112395
Lines: 2639-40
Column: CDSIC Synonym(s)

NCI EVS code: C112326
Lines: 3490-1
Column: CDSIC Synonym(s)

NCI EVS code: C112395
Lines: 3694-5
Column: CDSIC Synonym(s)

NCI EVS code: C112267
Lines: 4467-8
Column: CDSIC Synonym(s)

Same issue can be found in the QS Terminology’s and SEND Terminology’s flat file.

This issue does not exist in any of the flat files for 2014-03-28 release.

3

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