r Rajalakshmi



We are currently using Pinnacle21 Community version to create define and validation. We are able to create the define in v2.0 format. Is there a way to create define.xml in v2.1 format using Pinncle21 Community version. Please help.

Forums: Define.xml

on October 9, 2020

Hi Rajalakshmi,

No, now Pinnacle 21 does not support Define-XML v2.1. P21 support will be available after accepting this standard by regulatory agencies.

Kind Regards,

p Philip
on July 14, 2021



FDA begins to support Define.xml v2.1 from 03/15/2021. When will P21 release the next version to support the standard?


Thank you,

on July 14, 2021

Hi Phillip, 

I cannot provide specific dates for starting support for Define-XML 2.1. It is still considered as low priority task due to lack of business demand for Define-XML 2.1 at this moment.

While FDA formally started accepting Define-XML 2.1 in 2021, "requirements begin" only in 2023. So far, I have never seen any study implemented using new version of Define-XML. All our clients including FDA and PMDA are asking about Define-XML 2.1 only in sense of curiosity. Everybody are still OK! with Define-XML 2.0. Users do not like changing their existing processes for no real benefits.

Yes, Define-XML 2.1 has some nice new features. But timing for their adoption is still coming in the next few years with FDA publishing new guidance documentation with therapeutic-specific requirements. Like current CBER guidance for vaccines or CDER Pilot OCE/OOD Safety Team Standard Data Requests.

Kind Regards,


j Jozef
on July 15, 2021

Dear Philip,

As one of the (co)developers of the Define-XML 2.1 standard, I already see a lot of use of it, also for sponsor submissions to the FDA.
If you do a search on the internet, you will find some tools, including mapping software (i.e. software that starts from a define.xml template to generate SDTM) that supports or uses Define-XML 2.1.

You may always contact me for more information.
Jozef Aerts

a Assia
on November 7, 2021


Any update on when P21 will support Define-XML 2.1 please?

Many thanks.




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