MedDRA version?

SD0008

RE: The supported check SD0008 (a.k.a. WebSDM IRx007, http://www.opencdisc.org/projects/validator/rules/sd0008)

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.

Thanks.

Re: MedDRA Version

Hi Ajith,

You can find an example on page 21 of the CRT_DDS (Define.xml) Specification, here is an excerpt:

<CodeList OID="ExternalCodeList.AEBODSYS"
  Name="MedDRA Adverse Events Dictionary" DataType="text">
  <ExternalCodeList Dictionary="MedDRA" Version="6.0"/>
</CodeList>

This example is for AEBODSYS, so make sure to change it to AEDECOD in your define.xml.

Regards,
Max

Re: SD0008

Hi Anthony,

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:

1.  Export the Preferred Term dictionary from your licensed version of MedDRA to a tab delimited file
2.  Save the file to "\config\data" folder
3.  Add the following rule to the <val:ValidationRules> section of the configuration file:

<val:Lookup ID="SD0008" Variable="<PreferredTerm> == AEDECOD"
   From="FILE:TAB:%System.ConfigDirectory%/data/<FileName>" 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 <FileName> is the name of the file you created in step 1 and <PreferredTerm> is the name of the column in the file that contains Preferred Terms

4.  Add the following rule reference to the "AE" ItemGroupDef:

<val:ValidationRuleRef RuleID="SD0008" Active="Yes"/>

Let me know if you have any questions.

Thanks,
Max

Thank you!

Thank you!