n Nitin
on

 

Hi We have few customs findings domains and following variables are flagged as expected in v1.4 using IGv3.1.3:

DTC, STRESN, ORRESU, STRESU.

In some SDTM findings domains like EG these are permissible so in any findings domain they should be permisible as well.

Forums: SDTM

s Sergiy
on July 25, 2013

Hi Nitin, 

Yes, we have already adjusted Core values for custom Findings domains exactly as you are suggesting.

Thanks, 

Sergiy

n Nitin
on July 26, 2013

Hi Sergiy, how can i implement this change in current version?

s Sergiy
on July 26, 2013

Go to "...\config" folder and open "config-sdtm-3.1.3.xml" file for editing.

If you have experience working with define.xml, it will be helpful. OpenCDISC config files are extension of define.xml standard. It's better to use some XML editor. However any text editor like WordPad will be OK too.

Find and replace ItemRef

ItemRef ItemOID="FINDINGS.__ORRESU" OrderNumber="19" Mandatory="No" Role="Variable Qualifier" val:Core="Expected"/>

with

ItemRef ItemOID="FINDINGS.__ORRESU" OrderNumber="19" Mandatory="No" Role="Variable Qualifier" val:Core="Permissible"/>

Do the same with other variables.

Kind Regards,

Sergiy 

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.