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November 11, 2020 at 4:02 pm #3846
for both questions – are you asking about the approval documentation being distinct from the approved documents?
if I understand you correctly, the IRB approval letter/form should go in 4.1.2
while the actual approved documents go in their respective Zone 2 folders (2.1.4 for protocol amendment and 2.2.3 for ICF)
it would be helpful to clarify exactly what you’ve received from the IRB