Hi Garima,
Since your study is only being conducted in the US you do not need to produce a DSUR.
You just need to submit an IND annual report to FDA.
The DSUR is required by EU and other health authorities.
FDA will accept a DSUR in lieu of an IND annual report but for a phase 1 study it's probably not worth the effort to produce the DSUR.
When you have multi-national studies and you have to produce a DSUR, then you might as well submit it to FDA in lieu of the IND AR.
I don't think there is a requirement to ask FDA for permission to submit a DSUR in lieu of the IND AR, but I usually do out of courtesy.
Just don't forget about the US regional appendices listed in the ICH guideline.
Just to be sure, has a DSUR ever been produced for your product?
Are there any previous ex-US studies even in other indications?
Any CTAs that have not been closed out?
If yes, then you might need to produce a DSUR.
If no, then nothing to worry about.
Good luck!
Brian
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Brian Martin
Mountainside NJ
United States
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Original Message:
Sent: 27-Apr-2020 18:03
From: Garima Sharma
Subject: Requirement of DSUR
Hello fellow members,
Our company is sponsoring a phase I Clinical Pharmacology study with healthy volunteers and special population involving only US sites. My question here is whether we will require a DSUR submission or not for this study? As per ICH E2f guidelines, it says DSUR is required for all clinical trials involving human pharmacology, etc. However the dilemma is that this is only US based study, so can we submit IND AR instead of DSUR?
Thanks in advance!
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Garima Sharma
Mountain Lakes NJ
United States
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