AETRTEM flag in SUPPAE

Pinnacle 21 Support SDTM
1

Hi Mehadja,

SD1097 and SD1321 are official FDA Validation Rules.

Please see https://www.fda.gov/media/103587/download at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources for details.

Kind Regards,
Sergiy

2

Why is there still a check for the AETRTEM flag in SUPPAE when there is no longer a mention of this variable in the FDA Study Data Technical Conformance Guide?

Thanks.