p Pavel


The EDC being used collects --REASND at the event, form, or item level (Intentionally Left Blank and ILB REason are properties of event, form, and item EDC levels). The field is present in EDC extracts, but it is not represented on the rendered CRF. It is standard to annotate the CRF with --STAT=NOT DONE when --TESTCD=--ALL, but what about annotating --REASND if not present on the rendered CRF page? Is it acceptable to annotate as "--REASND when --ORRES=null" and use typical Type=Collected / Source=Investigator with the PDFPageRef of the annotation text?  Type=Assigned seems inappropriate since the Source is Investigator. 

Forums: Define.xml

j Jozef
on November 9, 2021

IMO best is to make an annotation at the top of the CRF page (althoug there is no field), reference that, and explain in the Reviewers Guide why "reason not done" does not appear on the CRF.
And/or do that as a comment in the define.xml as a def:CommentRef / def:CommentDef pair on the ItemDef for "REASND". The def:CommentDef can also point to the page in the Reviewers Guide where this is explained in detail.

p Pavel
on November 10, 2021

Thanks, Jozef! 

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