SD0063 SDTM/Dataset label mismatch for 3.1.1 uses 3.1.2

a Aleksandra

on June 20, 2012

Hi,

It seems to me that OpenCDISC 1.3 is incorrectly using SDTM 3.1.2 variable label check for SDTM 3.1.1.

I have several SDTM 3.1.1 variables that do not generate errors using OpenCDISC 1.2.1 but do generate errors using OpenCDISC 1.3. Moreover, the labels match what OpenCDISC says it is using for the check. Furthermore, when I replace the correct SDTM 3.1.1 labels with incorrect (SDTM 3.1.2) labels, the errors disappear. This particular sequence has only been tested for the data-only validation so far, but I will be looking at data-only, define-only, and define-plus-data in the next few days.

Thanks!

Forums: SDTM

s Sergiy

on June 21, 2012

Hi Aleksandra, It’s very

Hi Aleksandra,

It’s very interesting. I could not find any inconsistencies between previous and current OpenCDISC validator versions regarding SDTM 3.1.1 labels data.

Could you email me your files for further investigation of this issue? I need

1. opencdisc-validator\config\config-sdtm-3.1.1.xml

2. opencdisc-validator\config\data\SDTM Metadata 3.1.1.csv

My email is “Sergiy at opencdisc dot org”

Thank you,

Sergiy Sirichenko

s Sergiy

on June 25, 2012

Thanks to Aleksandra for

Thanks to Aleksandra for off-line communication, which helped to discover that SDTM 3.1.1 validation specifications v1.3 currently available for download from our website have errors. Checks SD0055, SD0058 and SD0063 use SDTM 3.1.2 metadata. This issue was already fixed right after the official release of the version 1.3 and the corrected “config-sdtm-3.1.1.xml” file is available on

http://svn.opencdisc.org/validator/trunk/config/

Best Regards,

Sergiy Sirichenko