j Jon
on

 

When will the Controlled Terminology files for 2017-03-31 appear on the webpage https://www.pinnacle21.com/downloads/cdisc-terminology ?

Thanks

 

Forums: General Discussion

a Ashwin
on May 10, 2017

please could you give us an ETA for this CT version?

j Jozef
on May 10, 2017

As I was in the same urgent need for this, this is what I did as a temporary solution:
I downloaded the 2017-03-31 SDTM-CT from: https://evs.nci.nih.gov/ftp1/CDISC/SDTM/ (file "SDTM Terminology.odm.xml").
In my Pinnacle21 distribution, I navigated to \components\config\data\CDISC\SDTM and created a new folder 2017-03-31.
In the folder, I copied the file "SDTM Terminology.odm.xml" and renamed it to "SDTM Terminology 2017-03-31.odm.xml" - Done.
Remark that I am not sure whether it is necessary to rename the file. I usually do just for clarity.

Also remark that this is a temporary solution only. As soon as Pinnacle21 publish their 2017-03-31 terminology, I will replace the file with the one from Pinnacle21.
It is then also interesting to create a "diff" between the Pinnacle21-CT file and the one from CDISC-NCI to see what the differences are. There are several (also free) tools available on the internet to generate "diff"s between XML files. I think the major differences are that the Pinnacle21 files contain def:ValueList and def:WhereClause elements, which are essentially define.xml elements.

s Sergiy
on May 12, 2017

Hi Jon, 

Sorry for delay. New CDISC CT configuration files are available our website now: https://www.pinnacle21.com/downloads/cdisc-terminology

Be aware that you should not use original CT files from CDISC as suggested by Jozeff ( XML4Pharma )

Kind Regard, 

Sergiy

j Jozef
on May 12, 2017

Hi Sergiy,

Could you please explain why one should not use original CT files (even not as a temporary solution)? Would this break some of the rule validations?
Please explain in detail.

s Sergiy
on May 12, 2017

Hi Jozeff, 

Please see an example on page 1 of this paper: http://www.lexjansen.com/pharmasug/2017/SS/PharmaSUG-2017-SS05.pdf

Kind Regards, 

Sergiy

j Jozef
on May 14, 2017

Thanks Sergiy!
Yes, each time a new SDTM-IG is published for public review, I protest against setting "(NY)" in the "Controlled Terms" column and then restricting it further by writing AS A TEXT things like "The value should be 'Y' or null". That is far away of what we designate as a "machine-readable" specification. The SDTM team however seems to be inconvincible ...

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