Cytodyn Inc (CYDY): The FDA regulations say the CRO is respo...

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Re: 3X Charm post# 203877

Thursday, 02/17/2022 5:34:52 PM

Thursday, February 17, 2022 5:34:52 PM

The FDA regulations say the CRO is responsible. I've worked for several CROs and had that drilled into my head during training. If they just provide personnel and the company maintains the EDC, TMF, oversight etc., then it's a hybrid system and responsibility is in accordance with the MSA.

This was a big issue when CROs started so it was addressed directly.

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