No Treatment Emergent info for Adverse Event

Pinnacle 21 Support SDTM
1

There SHOULD not be any imputed data in SDTM, but the sad reality is different …
This is a requirement added by the FDA on top of what CDISC has as requirements.
According to the CDISC principles, “treatment emergent flags” should only appear in ADaM, but the FDA also wants it in SDTM.

Also see: FDA Final Guidance Webinar Q&A | Pinnacle 21

2

Hello,

There is an error in AE domain: No Treatment Emergent info for Adverse Event.

The description of rule 1097 states, it should be included in SUPPAE. But there is no imputation done at sdtm level, so how can one create emergent flag?

Thanks,

Abdul.