Mike,

Here are a couple additional comments to go along with Chris's. The FDA put the
SDTM into an eCTD submission guidance a couple years ago as a way that you could
submit study tabulation datasets. It wasn't and still isn't a requirement, but
we remain hopeful that will eventually come to pass. It hasn't yet come to pass
in part for reasons Chris mentions below.

ADaM has not yet been put into FDA submission guidance, but we hope to see it
treated the same way as the SDTM eventually. First, as a suggested submission
standard and then - hopefully - both the SDTM and ADaM would be required. Many
folks are waiting for the FDA to require these models, but it will be a bit
longer before that happens in all likelihood. In the meantime, you can be sure
that the FDA is supportive of both the SDTM and ADaM.

Good luck,

Jack

--- In rtp_cdisc@yahoogroups.com, "Chris Decker" <cdecker@...> wrote:
>
> Hi Mike,
>
> Well I'll attempt to throw in my 2 cents. A few years ago (2006) the FDA was
making a push to require SDTM as a submission standard. This was the proposed
'rule' that would then become a regulation. I think this hit a bit of a
roadblock when the FDA identified some gaps in SDTM that did not quite meet all
their needs (thus the delay in 3.1.2). In addition, over the last few year the
FDA has started down the path of requiring submissions in HL7 by 2013/2014. So,
based on these two points I think the rule is still on the table but I don't
know how much it is being pushed.
>
> Saying that, I know the FDA just signed a 2 year contract to have all their
reviewers training on both SDTM and ADaM so I think the support is still very
strong. SO my guess is that SDTM will be strongly recommended but probably not
a rule/requirement until they figure out the direction of HL7. But this is one
person's opinion.
>
> As for ADaM I'm not sure if it will ever be required. I think they might
recommend following a structure like ADaM but I'm not sure about requiring it.
>
> --- In rtp_cdisc@yahoogroups.com, "Molter, Michael" <mmolter@> wrote:
> >
> > 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 Neuse Road, Suite 400
> >
> > Raleigh, NC 27609
> >
> > 919-926-5710 (work)
> >
> > 919-414-7736 (mobile)
> >
> >
> >
> > ** INC Research is a registered trademark of INC Research, Inc. Notice:
This transmission is intended only for the use of the individual or entity to
which it is addressed and may contain information that is privileged,
confidential and exempt from disclosure. If the reader of this message is not
the intended recipient, or an employee or agent responsible for delivering the
message to the intended recipient, you are hereby notified that any disclosure,
dissemination, distribution or copying of the communication is strictly
prohibited. If you have received this communication or any associated
attachments in error, please notify the sender immediately. Thank you in
advance.
> >
>