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