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Re: misiu143 post# 209470

Thursday, 05/26/2022 3:24:24 PM

Thursday, May 26, 2022 3:24:24 PM

Post# of 233759
Clinical sites are required to maintain their records until after the last filing for an intern indication or the IND is closed out. They must be made available to the sponsor, their delegates and regulatory authorities. They can be sent off site but are normally requested to be able to be available on site within 3 to 5 business days of a request. That is pretty typical boilerplate language for site contracts. Anyone who does clinical research is set up for that.
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