4 Radnor Corporate Center
Suite 350
Radnor, PA 19087
+1 (888) 507-2270
SD0001: No records in data source
Forums: SDTM
s
Sergiy
on November 29, 2018
No, empty datasets should not be submitted
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
l
Lex
on November 29, 2018
HasNoData
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
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!