Submission without EX domain

[Sergiy]

Hi Bharath,

Yes, it’s OK! to submit observational study data to FDA without EX domain.

It is always a good practice to communicate to your FDA reviewers in advance about your proposed plan. There are two major options:

• Use Study Data Standardization Plan (https://www.pinnacle21.com/blog/how-prepare-study-data-standardization-plan-sdsp-fda)
• Email your question to FDA eData team at cder-edata@fda.hhs.gov (https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/study-data-submission-cder)

EX domain is not applicable in some observational studies. Current CDISC and FDA validation rules are designed for clinical trials. Recently CDISC has started addressing this issue of limited standards support for observational studies. See https://www.lexjansen.com/phuse-us/2019/si/SI08_ppt.pdf

Kind Regards,

Sergiy

[bharathkumar.v]

Hi Sergiy,

I appreciate your timely support. Points noted.

Regards,

Bharath, V

[bharathkumar.v]

Dear Team,

Is it advisable to submit a study to FDA without EX domain in case of an observational study?

This study comprises of deceased subjects where the contrast agents provided to them is being monitored or analysed. Hence this detail is captured in the AG domain.

Also, i would like to know the list of Mandatory domains for SDTM submission.

Regards,

Bharath, V