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Posted On: 11/21/2025 3:13:16 PM
Post# of 158792
I asked ai because I dont know anyone else. But she's not infallible.
"A rollover trial can start before the end of the original trial by amending the protocol. However, the sponsor must submit the changes to the FDA, get approval from the Institutional Review Board (IRB), and follow the specific regulations for amendments, which can be complex depending on the type of change"
"A rollover trial can start before the end of the original trial by amending the protocol. However, the sponsor must submit the changes to the FDA, get approval from the Institutional Review Board (IRB), and follow the specific regulations for amendments, which can be complex depending on the type of change"