k Kyle
on

 

Hi, 

I have several studies for a study drug from 2012 until now, and some of studies are ongoing. For integrating (or pooling) data across multiple studies, we are still using SDTM controlled terminology 2012-12-21. Here is  a questions, if we would like to use OpenCDISC/Pinnacle21 Community v2.x for our study validation, is that possible to have earlier CT version for Community 2.x in this case?

Forums: SDTM

j Jozef
on March 8, 2016

Hi Kyle,

I haven't tried it yet, but I guess the following should work:

Go the directory components\config\data\CDISC\SDTM and create a directory named "2012-12-21".

Then in that directory, add the xml files with the CDISC-CT of that date, with the name "SDTM Terminology.odm.xml". Take care that this file has the same structure as e.g. a similar file in the directory "2015-09-25".

This assumes that you want to use it for SDTM. It is for ADaM, there is a similar directory "components\config\data\CDISC\ADaM".

Please let us all know whether this solved your problem.

d Dmitry
on March 9, 2016

According to this note versions 2.x does not allow you to easily add a custom terminology:

For 2.x, users cannot add controlled terminologies.   With the advent of 2.0, we will keep the software up to date by automatically pushing the latest versions of CT to the desktop when available.   OpenCDISC 2.x also requires the use of the ODM formatted CT files.  Because CDISC does not release these files in the proper format required for validation, the files from the CDISC website are modified before packaging with OpenCDISC Community.  Adding raw *.odm.xml files to OpenCDISC Community will have adverse consequences.  If you feel you need an earlier version that what is deployed, please contact support and we can evaluate the request for you.

 

At the same time you can try to convert CDISC CT to Pinnacle 21 format manually. It looks very similar to define.xml format of a codelist.

j Jozef
on March 9, 2016

That would indeed be a pitty!!! My own SDTM-ETL software exactly allows this, even allowing users to make extensions to codelists and storing these as a new "controlled terminology version".
The format that is used is indeed very close to define.xml codelists (for a good reason...). I have a stylesheet available that transforms the by NCI published CT into this format, and if anyone would like to obtain a copy of it, just contact me.

Just for fun, I just tried the following: I copied the folder "2015-09-25" and renamed the copy into "2011-01-01". After that, I started the validator and selected to validate a define.xml file. In the "CDISC CT" selection on the right "2011-01-01" appeared and I could select it, and start a validation. It worked!

So if you take care that the format is correct ("define.xml format"), my suggestion should work.

k Kyle
on March 14, 2016

Hi Dmitry,

I can convert it by myself actually, but I'm just wondering if it can be provided offically and maintain by Pinnacle 21 team in case of any errors.

 

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