No Treatment Emergent info for Adverse Event

Pinnacle 21 Support SDTM
1

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

2

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?