OpenCDISC 1.5 SD0056 error for MLPSTRGU variable

y Yi

on April 24, 2014

Dear All,

I was testing OpenCDISC1.5 today and there is a error message for SD0056 (SDTM required variable not found) that looks strange. It shows variable MLPSTRGU that is not found on the Meal dataset. However, I didn't find any information about this variable0 MLPSTRG on SDTMIG or online. Please advice.

DOAMIN VALUE RULE ID MESSAGE CATEGORY SEVERITY

ML MLPSTRGU SD0056 SDTM Required variable not found Metadata Error

Thank you!

Bessie

Forums: SDTM

s Sergiy

on May 1, 2014

Hi Bessie, Thank you for

Hi Bessie,

Thank you for reporting this issue!

--PSTRGU is "Pharmaceutical Strength Units" variable recently introduced in SDTM v1.4.

Yes, this variable should not be Required for custom Intervention domains. It's a bug in OpenCDISC specifications for SDTM IG 3.2.

As a temporary solution you can ignore this false-positive messages or change OC Validator specifications manually by editing a "config-sdtm-3.2.xml" file in "...\opencdisc-validator\config" folder.

Find and replace the following text (row #522)

<ItemRef ItemOID="INTERVENTIONS.PSTRGU" OrderNumber="40" Mandatory="Yes" Role="Variable Qualifier" val:Core="Required"/>

<ItemRef ItemOID="INTERVENTIONS.PSTRGU" OrderNumber="40" Mandatory="Yes" Role="Variable Qualifier" val:Core="Permissible"/>

Sorry for inconvenience.

Kind Regards,

Sergiy