QS domain - logically skipped items in C-SSRS

d Deepika

on May 21, 2018

Hi, In recent TCG v4.0 and 4.1, FDA has guidance to map logically skipped items in QS domain. My company collected Coulmbia Suicide Rating Scale (C-SSRS) and there are Describe questions which are typically blank based on response for previous Y/N question. We haven't mapped this in the past, but looks like FDA guidance is to map these. Has anyone does this and any thoughts/issues doing it.

Thanks.

Forums: SDTM

s Sergiy

on May 23, 2018

I would recommend you to contact FDA team

Hi Deepika,

Yes, there is an inconsistency between CDISC interpretation and FDA request for implementation C-SSRS questionnaire. I would recommend you to contact FDA team for clarification if needed. Depends on FDA division you are planning to submit your application, email your question to:

CDER eData ( cder-edata@fda.hhs.gov)

CBER (cber.cdisc@fda.hhs.gov)

Kind Regards,

Sergiy

s Suhel

on October 4, 2018

Updates

Hi Deepika- did you contact the FDA? If yes then what is the respose?

d Deepika

on February 5, 2019

I did but not whether we…

I did but not whether we should or should not implement it - seemed to me they want us to map it this way. I asked if they had an example and they did not, but based on C-SSRS they pointed me to the instructions and to map accordingly.