Elaine,
Check out the top of page 38 of the CDISC SDTM implementation guide.
There is a comments domain called CO which generally should hold all
of your true freestanding comment data no matter where it comes
from. However, if your comment text is really an answer to a
specific domain question, then maybe a supplamental qualifier is in
order. Whichever direction you go in, try to define a company
standard and stick to it.
Cheers,
Jack
--- In rtp_cdisc@yahoogroups.com, "Elaine" <Elaine.Dempsey@...> wrote:
>
> Hello.
>
> We are trying to get our act together to start implementing CDISC
> standards and prepare fo electronic submissions. We are just a
group
> of four and none of us have had that much experience with CDISC, so
I
> am hoping to get some suggestions regarding comments on a CRF.
>
> Would it be better (CDISC-wise) to have one central dataset named
> COMMENTS to hold all comments from the CRF? Or, would it be better
to
> leave each comment with the data from the associated CRF page. For
> instance, should a comment on the AE crf page be stored in the AE
> dataset.
>
> Thanks in advance.
>
> Elaine Dempsey
> Talecris Biotherapeutics
>