CDISC Terminology for Validation

CDISC Terminology for Validation

Great!
Could you also publish instructions how these need to be installed in (or added to) the software distribution? For me (as a software and XML expert) it was easy, but for other people it might not be immediately clear.

It would also be great if we know which CT versions have been installed / updated / corrected at the instances that the FDA is using. My customer still has a big stomach ache with the incorrectly installed version 2016-03-25 (see https://www.pinnacle21.net/forum/issue-terminology-set-invalid and https://www.pinnacle21.net/forum/wrong-ct-version-implemented-beatsmin-unit). With these downloads we can now correct that ourselves, but how about the FDA? As long as my customer is not 100% sure that the FDA has also corrected this in their instances, they cannot make their submission.

A suggestion for the software: using RESTful web services, such updates could be installed automatically.

Hi Jozef,…

Hi Jozef,

The instructions will be made available shortly.

The CT files made available on our website are exported directly from Pinnacle 21 Enterprise, the version used by FDA and PMDA. So they will always be in sync with the versions used by the agencies.

To make it even either, we will be making the updates available automatically via web services later in 2017.

Best regards,
Max

Instructions for controlled terminology update

Here is how I "repaired" the incorrectly installed March-2016 CT which however contained March-2015 CT. Max, please correct me if that is not the correct way to do this.

- Go to the folder "components\config\data\CDISC\SDTM".
- Delete the whole folder "2016-03-27".
- Create a new folder "2016-03-25".
- Download the file "SDTM Terminology 2016-03-25.odm.xml" from https://www.pinnacle21.com/downloads/cdisc-terminology.
- Store this file into the folder "2016-03-25".
- Then rename this file into "SDTM Terminology.odm.xml"  (attention: file name contains a single blank after "SDTM").
- Test whether everything works fine by using the validator, it should show an entry "2015-03-25" under "CDISC CT", and do a test validation using this CT version.

This worked perfect for me.

Thanks,

Jozef
 

Yes. It's correct.

Yes. It's correct.

https://www.pinnacle21.com…

https://www.pinnacle21.com/configuring-pinnacle21-community-validator-cdisc-controlled-terminology

SDTM and SEND CT 2018-03-30…

SDTM and SEND CT 2018-03-30 are available now for download

Impact of incorrect configuaration

Dear Pinnacle21 team,

are there any insights of what happens in case the Controlled Terminology is not renamed , but stored in the native naming convention (e.g. SDTM Terminology 2019-03-29.odm.xml) as provided on the P21 homepage?

It appears that the respective Controlled Terminology is selectable in the applications (in scope are P21 version 2.2.0, 2.1.0)  and can be used to create reports without the application throwing errors or warnings. However, the created reports seem to lack certain checks (like checks associated with the Controlled Terminology of the TS domain).

Could you please provide feedback about what the application is roughly doing at the background. Is it using the wrong Controlled Terminology, but is not able to perform certain checks correctly? Or is it doing something completely different ?

Many thanks in advance.

Regards,
Stefan

Sergiy

on October 2, 2019

P21

Hi Stefan, Pinnacle 21…

Hi Stefan,

Pinnacle 21 Community 2.x relies on correct configuration of CDISC CT files. In particular, if a folder with a name of CT version exists, then the validator assumes that this folder includes a correct CT file. Missing CT file or incorrect name (e.g., " SDTM Terminology 2019-03-29.odm.xml" instead of " SDTM Terminology.odm.xml") will result in missing validation for most CT rules. Invalid CT file (e.g., downloaded from NCI website instead of Pinnacle 21) will result in potentially incorrect validation. Particularly, it will not performed CT rules for value level items like TSVAL for TS Parameters.

This is one of the reason why Community 3.0 introduced auto-update functionality to ensure that CT files are installed correctly. 

The similar issue exists for other controlled terminologies and dictionaries in Community 2.x. For example, if you create an empty folder for MedDRA version, you can select this version in GUI, but MedDRA validation will not be performed due to missing configuration files. 

Kind Regards, 

Sergiy  

Hello Sergiy, thank you so…

Hello Sergiy,

thank you so much for your response!

If possible, would you be able to provide a list of the impacted CT rules or alternatively instructions how I could identify ignored CT rules? What would be the impact to the ADAM CT rules ?

As you also briefly mentioned the deployment of MedDRA dictionaries . I recognized that Pinnacle provides two installation manuals. One installation manual describes the manual copy&pasting into sub-folders and the other installation manual described the installation via the installation process provided by the Pinnacle21 GUI. Only, the latter seems officially linked anymore. Do I rightly assume, that the manual copy&paste installation process is still functional, but maybe less prefered as being more error prone?

Many thanks and Kind regards,
Stefan

Sergiy

on October 10, 2019

P21

All CTxxxx rules utilize CT files

Hi Stefan, 

All CTxxxx rules utilize Pinnacle 21 CT files. The missing or incorrectly named CT file results in skipping execution of all CTxxxx rules.  

Installation of MedDRA in Community 3.x is designed to work by provided user interface. I did not test an option to directly copy MedDRA files in their designated folder.

Kind Regards, 

Sergiy