j Jozef
on

 

I have a sponsor-defined findings domain XX.

When I validate the dataset xx.xpt I get a warning that rule SD0057 is violated: variable XXDTC is missing. It is "expected".
I do indeed not have this variable in my dataset.

My question:
- I have not been able to find in the standards document nor in the IGs that --DTC is expected in the case of a sponsor-defined domain. Can you point me to the paragraph where this is stated?
Or has it simply be assumed that it is so as it always is expected in the standard findings domains?

Many thanks in advance,

Jozef Aerts
XML4Pharma

Forums: SDTM

m Max
on July 1, 2010

Hi Jozef,

Make sure you are using the latest set of configuration files. The --DTC variable in custom findings domains have been changed to Permissible in the latest release. Please refer to the release notes for the full list of changes: http://svn.opencdisc.org/validator/tags/validator-1.1.0/config/CHANGELOG.txt

Regards,
Max

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