Implementation of SDTM-IG 3.4 and ADAM-IG 1.2/1.3

Pinnacle 21 General General Discussion
1

Hi Joran,

P21 Community support for ADaM-IG 1.2 and 1.3 will be available in the next engine release within few weeks,

SDTM-IG 3.4 is not in FDA Data Standards Catalog yet.

Kind Regards,
Sergiy

2

Any updates on the next engine release? It has been a few weeks since June 2023.

3

Dear Sergiy,

Will P21 Community add support for ADaM-IG 1.2 and 1.3 soon?

These standards are required by FDA as of 15 MAR 2024.

Kind regards,
Jeroen

4

Hi,

When will SDTM-IG 3.4 and ADAM-IG 1.2/1.3 be available on Pinnacle Community?
If I am not mistaken, FDA supports ADAM-IG 1.2/1.3 since 07/18/2022.
Thank you in advance.

Kind regards,
Joran