If the subject of the notice is unrelated to the outstanding matters defined by the conditions, then yes. If there is some interconnection, then maybe (depending on the nature of their interrelationships) and I would recommend a quick email to the lead review for asking for guidance on how best to handle the change. If the subject of the notice is intended to directly resolve the condition(s), either in part or in whole, and if time allows, then in most cases you would simply include it in a relevant supplement that addresses the specific condition(s).
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David Collette RAC
Associate Director, Regulatory Affairs
Brea CA
United States
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Original Message:
Sent: 24-Mar-2021 17:03
From: Anonymous Member
Subject: 5-Day Notice after IDE conditional approval
This message was posted by a user wishing to remain anonymous
Hi All,
I have question regarding IDE 5-Day Notices. Can a sponsor submit 5-Day Notices for changes if the IDE has received approval with conditions, which do not prevent enrollment? Or does the sponsor need to first respond to conditional approval and receive full approval before submitting the 5-Day Notices?
Thank you very much for helping with the question.