p Paula
on

 

Should the issues with severity of "Warning" be included in the SDRG?  Or just those with a severity of "Error"?

Forums: SDTM

b Brad
on January 22, 2016

Hi Paula,

I don't believe there is any agreed upon standard for which issues need to be included in the SDRG.

This needs to be decided on an issue-by-issue basis. If you believe that including an issue in the SDRG would provide any benefit to the reviewer, then it should probably be included and explained. But also note it is discouraged to submit the entire issue summary (unless every issue will impact review). So you should not be making these decisions based purely on severity. In fact, there are cases when every status (Error, Warning, Notice) should be included.

You will need to decide if the issues/explanations provide any value or orientation to the reviewer.

s Sergiy
on January 28, 2016

To make it clear.

Yes, you need to include all reported validation issues regardless of their Severity attribute value into SDRG.

Kind Regards, 

Sergiy

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