SD0001: No records in data source

Pinnacle 21 Support SDTM
1

Hi Marina,

No, empty datasets should not be submitted.

To document your case you need to use Reviewer’s Guide where is a special question if all planned to collect data are included?

Kind Regards,

Sergiy

2

Just to add, Define-XML 2.1 will have a HasNoData attribute on the ItemGroup element that can be used in this case. When HasNoData=“Yes”, no dataset is expected to exist.

Best, Lex

3

Hello!

I have the annotated CRF with specific domains, but for some of them there is no data. What should I do in this situation? Should the empty datasets be submitted and described in the define.xml document?

Thank you!