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SD0045 and SD0002 for TFRESCAT
Forums: Validation Rule Suggestions
Hi Amelia, Thanks for the
Hi Amelia,
Thanks for the reported issue. It looks like some inconsistencies in the SEND IG. We need to contact the SEND development team about this issue.
Meanwhile I would ignore (but clearly and fully document) SD0002 Errors (a missing value for required TFRESCAT variable) for such cases in the TF domain.
Regards,
Sergiy
Hi Sergyi, Thank you for the
Hi Sergyi,
Thank you for the quick reply.
If possible, please inform us also when you get a reply from the SEND team about this issue.
Best regards,
Amelia
TFRESCAT, TFSTAT and TFREASND
Dear Amelia,
The Tumor Findings (TF) domain is intended to capture only tumor findings, and is a subset of the records in the Microscopic Findings (MI) domain.
This implies that any records with an (MI)STAT of ‘NOT DONE’, does not get transferred into the TF domain, only diagnosed tumors.
It logically follows that the variables TFSTAT and TFREASND would not be used in the TF domain, and should be omitted. The SEND team will consider removing these variables from the domain, and listing them under assumption 5 as generally not appropriate for this domain.
On behalf of the CDISC SEND team
Gitte Frausing
Hi all,
I'm having the following situation:
If I populate TFRESCAT for situations when TFSTRESC=TFORRES is empty and TFSTAT=NOT DONE, the SD0045 warning is trigerred: "Missing value for --STRESC, when --RESCAT is populated".
But TFRESCAT is a Required variable, so if I try to leave it empty, the SD0002 error is trigerred: "NULL value in -- variable marked as Required".
I could either:
a) change optionality for TFRESCAT from Required to Permissible (as for MIRESCAT); but the SEND requirements will no longer be followed...
b) disable rule SD0045 for TF; not sure if the best idea, since the rule seems valid to me.
Can you please advise?
Thanks!
Amelia