Reply To: IRB Amendment Protocol

[Richard Golden]

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