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Hi everyone,
I know that the answer to this question may not be as simple
as people would like, but can anyone summarize where in the process the FDA is
in mandating SDTM? There was something about a "proposed rule" but
I'm not sure what that means. Is it mandated for electronic submissions only?
Is a time coming when it will be mandated for all submissions? Same question
goes for ADaM.
Any insight here is appreciated. Thanks.
I’ve posted the same question on the CDISC public
discussion forum.
Michael Molter
Principal
Statistical Programmer - Biostatistics
INC Research
4700 Falls
of
919-926-5710
(work)
919-414-7736
(mobile)
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