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Posted On: 05/07/2025 7:31:05 AM
Post# of 152657
Quote:
But most often ( if not always ) to save time they are send to both places simultaneously
If the IRB doesn't like the protocol then the company has to rescind the submission to the FDA and resubmit a revised protocol to the FDA that meets the IRB's standards. Which is why usually you get an IRB approval first.


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