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