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AETRTEM flag in SUPPAE

m MEHADJIA
 on February 2, 2021

 

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.

Forums: SDTM

Sergiy
on February 2, 2021
P21

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

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