m Manolya
on

 

Hi!

I have a case where this check pops up only when generating the cdisc report together with the define.xml. However, when using only the SDTM datasets, this check does not appear. Is anyone able to explain why this is so?

Thanks!

 

Forums: SDTM

s Sergiy
on January 4, 2016

What version of Validator are you using?

m Manolya
on January 6, 2016

I am using version 1.5 and I suppose that a cross-check to the MedDRA is not present, would that be the explanation?

When I am using the define, I use it together with a macro.

s Sergiy
on January 6, 2016

Hi Manolya, 

In v1.5 a define.xml is a source for MedDRA version used during validation. Define.xml metadata overwrites users settings in GUI. 

I assume that a version of MedDRA in your define.xml file is incorrect.

Kind Regards, 

Sergiy

P.S. We strongly recommend avoiding a usage of outdated versions of OpenCDISC Validator. Otherwise quality of your data may be compromised.

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