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j Jozef
on November 3, 2020

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 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!

on November 3, 2020

HI Jozef, 

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

Kind Regards,

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