Agree that its standard. FDA is the pivotal body at all times, as it retains veto rights on licensure.
Details on how trial roles & responsibilities (i.e. IRB, DMC, investigator) are to be divvied up by the sponsor to avoid a material Cof I are set out in the following current guidance from FDA: https://www.fda.gov/media/75398/download
A great (COVID-free) weekend to all holders.
Agree that its standard. FDA is the pivotal body at all times,...
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