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FDAC022 - No Treatment Emergent info for Adverse Event
s
Sergiy
on December 21, 2017
Do you have SUPPAE dataset?
Hi Manolya,
Do you have SUPPAE dataset? A check is not executed without it.
Thanks,
Sergiy
m
Manolya
on December 22, 2017
No SUPPAE dataset
Hi Sergej,
I don't have a SUPPAE dataset yet, that's why I am wondering. Why doesn't the check fire in this case? I think it should...
Best regards
Manolya
I am running the P21 v2.2.0 on my SDTM datasets, and I'm wondering why I don't get the warning for FDAC022 (as I did get previously in other studies). There is no SUPPAE for this study right now, so why doesn't the warning pop up? Is it not required by the FDA anymore?
Best regards
Manolya