From: rtp_cdisc_owner <jack.shostak@...>
Subject: [rtp_cdisc] Re: Rely to rule quesiton
To: rtp_cdisc@yahoogroups.com
Date: Thursday, June 4, 2009, 6:17 PM

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@yahoogrou ps.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@yahoogrou ps.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
> >
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> >
> >
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>