SD0057: Expected vars missing in custom findings domain

Pinnacle 21 Support SDTM
1

Hi Nitin,

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

Thanks,

Sergiy

2

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

3

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

4

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.