1777 Sentry Parkway West
Building 17, Suite 405
Blue Bell, PA 19422
+1 (888) 507-2270
Wrong CT version implemented? beats/min unit
Thanks for reporting this bug!
Hi Jozef,
Thanks for reporting this bug!
New fixed release will be available soon.
Kind Regards,
Sergiy
What should be interim solution for this 2016-03-25 terminology
Hi Sergiy,
What should be interim solution for validation of SDTM CT 2016-03-25?
Regards,
Saurabh
If you still have version 2.1.2, then you can copy correct files
Hi Saurabh,
If you still have a version 2.1.2, then you can copy a correct file folder "2016-03-25" and its content from "components\config\data\CDISC\SDTM".
Kind Regards,
Sergiy
Wrong CT version
Hi Sergiy,
For those not still having v.2.1.2, can we also simply download the file "SDTM Terminology 2016-03-25.odm.xml" from the NCI website, rename it into "SDTM Terminology.odm.xml" and put in the folder "2016-03-25"?
One of my customers has exactly the same problem, and their big fear is that the instance that the FDA is using has NOT been corrected for this bug, so that when the FDA is running the validator, they are thinking validating against the March 2016 CT version, but actually validating against a much older version, with all consequences and misunderstandings as a result.
Can Pinnacle21, as the vendor of the software, guarantee us that the CT version installed at the FDA is the correct one, i.e. that the bug has been repaired there?
This is utmost important information for my customer, as it otherwise may retard their submission for months.
Hi Jozef, …
Hi Jozef,
It will not work properly. There are many extensions to original CDISC CT. For example, Value Level CT or errors fixes.
Kind Regards,
Sergiy
Pinnacle 21 community Version: 2.2.0 CDISC SDTM CT
Hi Sergiy,
Thank you so much for your response.
My organization has concern about the rest of CDISC SDTM CT for Pinnacle 21 community version 2.2.0, that the other terminologies into SDTM folders are accurate or not with NCI terminologies? Can you please provide information about which other terminologies have issues in best of Pinnacle 21 knowledge and can Pinnacle 21 provide assurance the rest of terminologies into SDTM folder accurate in best of Pinnacle 21 knowledge?
Kind Regards,
Saurabh.
SDTM 2015-03-27 is the only incorrect CT in v2.2
Hi Saurabh,
SDTM 2015-03-27 is the only incorrect CT in v2.2
Kind Regards,
Sergiy
When validating my SDTM datasets I was already surprised that for the CT the validator presents me the choice "2016-03-27" whereas there is no such version on the NCI server: there is only a version "2016-03-25" and a version "2015-03-27".
I then did my validation and got warnings for the unit "beats/min". I checked in the file for "2016-03-25" from the NCI site and found that "beats/min" is present (all lowercase). So the validator shouldn't give a warning. So I was a bit stunned.
I then looked into the Pinnacle-CT file in the directory "2016-03-27" and found out that it states "SDTM-Terminology-2015-03-27.odm.xml" with "BEATS/MIN" (uppercase). So it looks as the Pinnacle-CT implementation mixes up "2015" and "2016", i.e. it puts a 2015 CT into a file that suggests it is a 2016 CT.
I can of course put the correct files from the NCI web site into the correct directories, but I don't think the FDA and PMDA will do so upon my request......