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SDTM IG v3.3 and Define xml 2.1

s Sophie
 on July 10, 2020

 

Hi,

Version 6.3 (07 July 2020) of FDA Data Standards Catalog is available now.

https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources

FDA will start support SDTM IG v3.3 and Define xml 2.1 on March 15, 2021 and will require it for a number of submissions starting March 15, 2022.

Based on this, I would like to know when you plan to add SDTM IG v3.3 and Define xml 2.1 configuration ?

Regards,

Forums: General Discussion

Sergiy
on August 11, 2020
P21

Hi Sophie, 

Support for validation of SDTM-IG 3.3 is will be available in the upcoming release of Community. 

Business demand for Define-XML 2.1 is still very low. All users are quite happy with Define-XML 2.0 and are not ready for changing their existing processes. Based on real needs of our clients, I expect that P21 support for Define-XML 2.1 will be introduced early 2021.

Kind Regards,
Sergiy

j Jozef
on August 12, 2020

As a member of the Define-XML Development and Training team, I must partially disagree with Sergiy:

We see a lot of interest for Define-XML v.2.1, especially from those who want to generate their define.xml upfront, i.e. pre-SDTM generation, or as a specification what needs to be delivered later by the provider. This is also the "best practice". We also see such an interest from the tooling side: we get a lot of questions about tools for v.2.1.

Also, the CDISC training course materials have now all been adapted for v.2.1, i.e. the CDISC Define-XML trainings are now teaching v.2.1.

r Rajalakshmi
on November 3, 2020

Hello!

Is there any update on when Pinnacle21 Community version will support generation of define.xml in v2.1? Our clients are insisting on this, as studies submitted after Mar 2021 requires define.xml to be submitted in v2.1. It would be really helpful if this functionality is available sooner. Thanks!

Sergiy
on November 4, 2020
P21

Hi Rajalakshmi, 

This is not true. In March 2021 FDA will start accepting Define-XML 2.1. It is not the same as being required. Define-XML v2.0 is still an option.

According to latest version of FDA Data Standard Catalog, there is no Date Support Ends for Define-XML v2.0. 

Kind Regards,
Sergiy

 

r Rajalakshmi
on November 4, 2020

Thanks for your prompt response Sergiy! But please let us know when we can expect that upgrade in the Pinnacle21 Community version though. Thanks!

Sergiy
on November 4, 2020
P21

When FDA will start accepting this new standard.

j Jeroen
on June 15, 2021

Dear Sergiy, 

 

FDA is accepting define.xml 2.1 now for 3 months. 

Any update on when P21 Community will allow validation of this standard?

It wasn't there in the most recent software update.

 

Thanks and regards,
Jeroen  

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