QS-FT Terminology 2014-09-26

Pinnacle 21 Support SDTM
1

Hi Brian,

This term with NCI Code=C111379 was introduced only in CDISC CT 2015-12-18. It does not exist in the version you refer to. Please clarify your question.

Regards,

Sergiy

2

It is in the QS_FT file from 2014-09-26, but I now see that it is incorrect there as well. I will just explain in the reviewer’s guide. Thank you.

3

Thank you! I was confused due to a merge of originally separate QS-FT (QRS, QS, etc.) CT to SDTM CT 2015-12-18.

Unfortunately, we cannot deviate from official CDISC Control Terminology and modify existing official standard terms.

As I understand, CDISC is not planning to correct any errors in their published standards. There is new Errata info published on CDISC WIKI https://wiki.cdisc.org/display/PUB/Errata+for+Foundational+Standards . However, it does not cover CT.

I recommend to document this issue and explain a validation message as an obvious error in a version of CDISC CT you utilized for the study.

Regards,

Sergiy

4

I found the same error. We have a database based on SHARE content that is serving the public RESTful web services.
The error (“missing I”) seem to exist in all the versions from 2014-03-28 up to 2015-03-27 (and including your version 2014-09-26). See picture:

C111379 from SHARE content.png
C111379 from SHARE content.png733×321 31 KB

You can always use the public RESTful web services that are described at: XML4Pharma Web Services (there are about 30 of them). Everything that is in there is SHARE content. For example for your cases:
http://www.xml4pharmaserver.com:8080/CDISCCTService/rest/SDTMTermFromNCICode/C111379/2014-09-26
returns “C-SSRS CHILDREN’S SINCE LAST VIST”
whereas http://www.xml4pharmaserver.com:8080/CDISCCTService/rest/SDTMTermFromNCICode/C111379/2015-06-26
returns “C-SSRS CHILDREN’S SINCE LAST VISIT”

I will take contact with the responsible people at CDISC and NCI and ask whether I am allowed to change this obvious error and also ask whether it can/should be corrected in SHARE.

5

There is a missing letter “I” for VISIT in the XML file:

CodedValue should be “C-SSRS CHILDREN’S SINCE LAST VISIT”

This appears to be corrected in later versions. I am trying to finalize a study with this version of CT - any chance that this will be updated?