Similar to Aj’s question, I am unable to find the rule definition for SD0008 in either configuration files (config-sdtm-3.1.1.xml and config-sdtm-3.1.2.xml). I tried searching using both v1.0.1 and v1.1 of the OpenCDISC Validator.
Further, am I correct to expect a seperate resource file within the OpenCDISC Validator folder structure for MedDRA preferred terms?
Any pointers as to how exactly this check works (including user configuration) will be appreciated.
You are correct, SD0008 is not included in the posted configurations. The issue is that MedDRA is commercially licensed, so we can’t distribute it freely with the Validator. Instead we have advised our users on how to manually add the check to the Validator configuration.
We are planning to post detailed instructions on the website in the near future, but here is the short version:
Export the Preferred Term dictionary from your licensed version of MedDRA to a tab delimited file
Save the file to “\config\data” folder
Add the following rule to the val:ValidationRules section of the configuration file:
<val:Lookup ID=“SD0008” Variable=“ == AEDECOD”
From=“FILE:TAB:%System.ConfigDirectory%/data/” When=“AEDECOD != ‘’”
Message=“Invalid value for Preferred Term”
Description=“Identifies records where the value for the Preferred Term could not be found
in the MedDRA dictionary”
Category=“Terminology” Type=“Error” Severity=“High”/>
where is the name of the file you created in step 1 and is the name of the column in the file that contains Preferred Terms
Add the following rule reference to the “AE” ItemGroupDef:
I got to know about OpenCDISC validator in recent PhramaSUG and trying to use it on a recent study(3.1.1). I was told that i need to include MedDRA vesrion in define.xml but not sure where to include that (other than comments for AEDECOD). Does versions go into codelist?