IRB Amendment Protocol

[Janna Gonzalez]

1. Where to File a IRB Amendment Protocol Approval_v2.0?
This document have two different approvals.
consent
Protocol v2

Should I file this document in Zone 04.01.02 and 02.02.03?

2. I have another IRB Amendment Protocol Approval v2.0. this document have three approval.
Protocol v2,
Consent,
IRB Approval acknowledgment letter.

Should I file in 04.01.02 and 02.02.03.
Please Advise.
Thank you,
Janna

[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

[Janna Gonzalez]

This is a IRB Amendment and Approval Letter Acknowledges 3 separate items.

This documents read for ‘3_Additional Approvals’.

acknowledges 3 separate items (PV2, consent, and APR) I would like to know the suggested naming convention for documents approving of 3 separate items.

Do I need to saved three of the same documents in the three different Zones?
04.01.02,
02.01.04,
02.02.03
Thanks,
Janna
thanksn

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