Support validation SDTM IG 3.4

Sergiy

on April 8, 2022

P21

So far, none of regulatory agencies accepts SDTMIG 3.4

Hi, 

A scope for Community Validator is to support regulatory submissions. So far, none of regulatory agencies (FDA, PMDA, NMPA) accepts SDTMIG 3.4.

Also, our industry metrics show that today most studies still utilize SDTMIG 3.2. There are 10 times less studies based on SDTMIG 3.3 compare to v3.2.

We are introducing support for SDTMIG 3.4 as beta version in Enterprise only. Plans for Community are still open and driven by FDA, PMDA and NMPA.

Could you explain why do you need SDTMIG 3.4 now? Are you planning some submission? Do you need some new domains or variables introduced in SDTMIG 3.4?

Kind Regards,
Sergiy 

FDA accepts SDTM IG 3.4

Hi Sergiy,

Is there a time schedule for when Pinnacle21 Community plans to support SDTM IG 3.4 validation, now it is accepted by the FDA? The requirement of this version will be started on 1year and 2months.

Thank you.

Kind regards,

Joan

FDA accepts SDTM IG 3.4

Dear Joan,

Did you ever get an answer to your question?
We do already (for a longer time) fully support SDTMIG-3.4 in all our products.

Matt

on February 5, 2024

P21

Hello Joan,   The P21…

Hello Joan,

The P21 validation engine, available in our Enterprise product, has had support for SDTMIG 3.4 validations. We recently released the FDA 2304.3 engine to support SDTMIG 3.4 validations following the FDA beginning support for SDTMIG 3.4 back in December. Speaking with our team, they let me know that the FDA 2304.3 engine is going to be available within Community in the next few weeks.

Kind regards,

Matt

Using SDTM IV v 3.4 and ADaM v 1.2 or latest

Hi Matt and Sergiy,

Do we have any update on when we will be able to validate against SDTM IG V 3.4 and ADaM V 1.2/1.3 on the P21 community version?

Thanks,

Kishore

SDTM IG 3.4 in command line

Dear Pinnacle21 team,

It looks like SDTM IG 3.4 support is available in Pinnacle21 Community GUI, but not in the command line. Can you please comment if SDTM IG 3.4 is supported by the command line version of the validator, and if not, will such support be added?

Thanks,
   Leonid

Matt

on April 30, 2024

P21

Hello Leonid,   I am able…

Hello Leonid,

I am able to successfully validate using SDMTIG 3.4 in both the GUI and with CCLI. What errors do you receive? If you wish to provide files/screenshots, feel free to post them here or email community@pinnacle21.com.

Kind regards,

Matt

Hello Matt, Sorry for the…

Hello Matt,

Sorry for the long delay in this thread, here's the info you requested. I am running the command line version of the validator as follows:

"c:\pinnacle21-community 4.0.2/resources/app.asar.unpacked/components/java64/bin/java.exe" 
  -jar "c:\pinnacle21-community 4.0.2\resources\app.asar.unpacked\components\lib\p21-client-1.0.7.jar" 
  --standard=SDTM --standard.version=3.4 --engine.version="FDA 2304.3" 
  --source.sdtm="c:\packages\SDTM" 
  --source.define="c:\data\packages\SDTM\define.xml" 
  --cdisc.ct.sdtm.version=2021-12-17 
  --report="c:\data\report.xlsx" 
 

It gives this error:

net.pinnacle21.oce.exceptions.CLIException: Config is required to run local validation, but was not provided or found. config=c:\pinnacle21-community 4.0.2\resources\app.asar.unpacked\components\lib\configs\SDTM-IG 3.4 (FDA).xml. input=Command line: --standard=SDTM --standard.version=3.4 --engine.version=FDA 2304.3 --source.sdtm=c:\data\packages\SDTM --source.define=c:\data\packages\SDTM\define.xml --cdisc.ct.sdtm.version=2021-12-17 --report=c:\data\report.xlsx

The file SDTM-IG 3.4 (FDA).xml it mentions does not exist. Interestingly, in the c:\pinnacle21-community 4.0.2\resources\app.asar.unpacked\components\lib\configs folder I have subfolders corresponding to various engines, but none for 2304.3.

Thanks,
   Leonid

Matt

on May 14, 2024

P21

Hello Leonid,   You…

Hello Leonid,

You previously had a similar report in https://www.pinnacle21.com/forum/pinnacle21-community-400-cli-issue. In it, I mention:

"Indicated in How to use Pinnacle 21 Community CLI, it mentions that "To get started using the CLI copy the CLI jar located at the path below and paste it to Documents\Pinnacle 21 Community". The default location for this is typically C:\Users\<user>\Documents\Pinnacle 21 Community. There should also be a configs folder located there.Then it will be able to locate the config based on the engine and standard version that you provide."

In my Pinnacle 21 Community\configs folder, I have a folder named 2304.3 and can validate with this engine both in the application and with the CLI. 


Your command appears to be running the JAR file from its original location. Can you try moving the JAR under the Pinnacle 21 Community folder? To get an idea where this may be, in the app you can navigate to Help > Preferences > Resources. Note, this will also list where your configs folder is.

Kind regards,

Matt

Hello Matt, I tried copying…

Hello Matt,

I tried copying the JAR file to Documents\Pinnacle 21 Community and using it from there, but the result is the same. The error message now mentions that it is looking for the file SDTM-IG 3.4 (FDA).xml under Documents\Pinnacle 21 Community, but it's not there either. Nor is the 2304.3 folder. I wonder where you got it from. I did a fresh installation of Pinnacle21 Community 4.0.2 on another computer, and can't see folder 2304.3 anywhere.

Thanks,
   Leonid

Matt

on May 14, 2024

P21

Hello Leonid,   Do you see…

Hello Leonid,

Do you see the engine in the dropdown under the Validation menu in the application itself? If so, validate in-app once and then see if the folders exist.

Kind regards,

Matt

Hello Matt, Yes! After I…

Hello Matt,

Yes! After I ran a validation once from the GUI, folder 2304.3 appeared under Documents\Pinnacle 21 Community, and after that, I can use this engine from the command line. Thanks a lot for your suggestion, it solved my issue!

Leonid

Matt

on May 16, 2024

P21

Hello Leonid,   Thank you…

Hello Leonid,

Thank you for the follow-up and confirmation that you can now validate with CCLI!

Kind regards,

Matt