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The purpose of using the latest version of SDTM?
s
Sergiy
on July 9, 2015
Hi Verna, While SDTM IG 3.2
Hi Verna,
While SDTM IG 3.2 is not in the list of "officially" accepted versions, FDA reviewers will be happy to get submission data in this version.
You can contact reviewers dedicated to your submission to confirm.
Kind Regards,
Sergiy
Hi,
I have some confusion about the SDTM version submission to FDA. For now, the latest version of SDTM is v1.4 and IG is 3.2( with AP v1.0 and MD v1.0). However, FDA, so far, only accept SDTM v1.3 (IG 3.1.3). Since we don't have the date for acceptancy of SDTM v1.4, then on what reason we can still use the SDTM v1.4?
Or new domains in the SDTM v1.4 can be treated as custom domain when submitted to FDA? What about AP-- domain, or new variables ?
Thanks in advanced!