FDAC022 - No Treatment Emergent info for Adverse Event

Pinnacle 21 Support SDTM
1

Hi Manolya,

Do you have SUPPAE dataset? A check is not executed without it.

Thanks,

Sergiy

2

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

3

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