SKIP_SD0008, SKIP_SD2008, SKIP_SD2009, SKIP_SD2010, SKIP_SD2012, SKIP_SD2015

n nalin

on May 24, 2012

Hello.

I wanted to check what data-checks are performed if the .asc files are provided?

Thanks,

Nalin

Forums: SDTM

s Sergiy

on May 25, 2012

Hi Nalin, Those checks

Hi Nalin,

Those checks compare AE coded data with MedDRA dictionary. You can find descriptions of rules on OpenCDISCwebsite (http://www.opencdisc.org/projects/validator/cdisc-sdtm-3.1.2-amend-1-validation-rules ) or in your validation report in the “Rules” tab.

E.g., “SKIP_SD0008” means that the check SD0008 was not executed because you did not provide the MedDRA dictionary file “pt.asc” in the specified folder. The SD0008 rule description is “Value for the Dictionary-Derived Term (--DECOD) variable must be populated using a Preferred Term of the MedDRA dictionary of a version specified in the define.xml”

If you want to validate MedDRA coding of AE data, then you need to use your company MedDRA license and your own MedDRA files. The configuration is very simple. See details on http://www.opencdisc.org/projects/validator/configuring-opencdisc-validator-meddra

Best Regards,

Sergiy Sirichenko