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AETRTEM flag in SUPPAE
SergiyP21
Hi Mehadja, SD1097 and…
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
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.