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