1777 Sentry Parkway West
Building 17, Suite 405
Blue Bell, PA 19422
+1 (888) 507-2270
No Treatment Emergent info for Adverse Event
SergiyP21
More details about your implementation are needed
Hi Hyewon,
More details about your implementation are needed.
So, you have SUPPAE dataset and each record in AE domain has records in SUPPAE where
- QNAM = 'AETRTEM'
- USUBJID = AE.USUBJID
- IDVARVAL = AE.AESEQ
Kind Regards,
Sergiy
I added AETRTEM variable of which label is Treatment Emergent Flag in SUPPAE as per FDA rule.
However , still see the 'No Treatment Emergent info for Adverse Event' error after validation using FDA engine.
Is it possible not to see this error?