Could you please check if PMDA 2211.0 engine with SDTM-IG 3.3 (PMDA) validation rule dose not validate define.xml v2.1?

m MinJi

on July 19, 2023

Hi, could you please check if PMDA 2211.0 engine with SDTM-IG 3.3 (PMDA) validation rule dose not validate define.xml v2.1?

Though syntax has no error, validation findings are reported.

e.g. Invalid def:DefineVersion value

Best regards,

MinJi

Forums: Troubleshooting and Problems

j Jozef

on July 20, 2023

PMDA 2211.0

Reason could be that PMDA does not formally accept Define-XML 2.1 yet, but according to Yuki Ando of PMDA, this will change soon.
If so, it looks as you are let down if you are already preparing a PMDA submission in the next months, and want to do so with Define-XML 2.1 (which I always strongly encourage).

m MinJi

on July 20, 2023