Support for validation of SDTM-IG 3.3

Support for SDTM-IG 3.3

Thanks Sergiy!
Can you tell us what they are based on? As far as I know, FDA has not published rules for SDTMIG-3.3 yet (but I will be glad to be teached better), and I could also not find them at https://www.pinnacle21.com/validation-rules/sdtm. Or are they based on the by CDISC published rules, or on the old FDA rules, or a mixture of both?
Many thanks in advance!
Jozef

Sergiy

on November 3, 2020

P21

HI Jozef, Those are a mix…

HI Jozef, 

Those are a mix of SDTM conformance rules from CDISC and FDA rules.

Kind Regards,
Sergiy