Regulatory Open Forum

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

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May Litt
Clinical Operations Consultant
Weirsdale FL
United States
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It depends. FDA considers IDE/IND review of protocols and protocol amendments as separate procedures. I would only wait to submit for IRB approval of the amendment if I thought it was possible that FDA would require further changes in the amended protocol. You will need to weigh the possibility of delays in implementing the amendment by not submitting the amendment in parallel versus needing to resubmit the amendment to the IRB if FDA requires further modifications.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

For drug (IND) studies, the FDA does not have a review and response process for protocol amendments, even major ones.  There is no 30 day requirement as there is for initial IND submissions.  Typically FDA will not even respond (ever) to a protocol amendment unless they have a significant safety concern. 

As noted in 312.30(b)(2), a protocol amendment can be implemented as long as it is SUBMITTED to FDA and it is approved by the IRB(s).  There is no requirement or expectation to obtain FDA approval for a protocol amendment or any waiting time.

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Michael Hamrell, Ph.D., RAC, FRAPS
Nipomo CA
United States
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Original Message:
Sent: 08-Sep-2022 07:53
From: Glen Park
Subject: Question on protocol amendment IRB notification

It depends. FDA considers IDE/IND review of protocols and protocol amendments as separate procedures. I would only wait to submit for IRB approval of the amendment if I thought it was possible that FDA would require further changes in the amended protocol. You will need to weigh the possibility of delays in implementing the amendment by not submitting the amendment in parallel versus needing to resubmit the amendment to the IRB if FDA requires further modifications.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

This message was posted by a user wishing to remain anonymous

FDA does not send approval letters to the protocol amendments so go ahead and submit it to the IRB ASAP. Next time just submit concurrently!
Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

Original Message:
Sent: 9/7/2022 4:46:00 PM
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

Hi May.

As a rule you will not be able to implement any changes to the protocol until the IRB approves the change and any necessary changes that they might make to your informed consent (as well as any decision on how exactly to manage the newly required information for those who have already been through the consent process before the protocol change/update).  So waiting to get FDA's approval before submitting the information to the IRB could actually be seen as problematic because now FDA has approved and expects that the change will be taking effect while the IRB has not even seen the change yet.

I agree completely with the other responders - submit concurrently.  It saves time, energy and money in the long run when you have the ability to simply move forward with the study once everyone is on the same page.  It also avoids that issue of the black hole that might come from FDA not officially notifying you of their approval as someone else mentioned.

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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
------------------------------

Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

Thank you all for your feedback! My instinct was to submit to the FDA and IRB in parallel. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------

This message was posted by a user wishing to remain anonymous

If it is a major amendment where we expect FDA will request changes/additional information we wait to avoid submitting multiple modifications to IRB, which actually end up taking more time.
Original Message:
Sent: 07-Sep-2022 16:45
From: May Litt
Subject: Question on protocol amendment IRB notification

Hello,

For a major protocol amendment submitted to the FDA, should the IRB be informed ASAP or should the IRB be informed upon FDA approval of the protocol amendment? I can't find anything conclusive on this. Thank you!

------------------------------
May Litt
Clinical Operations Consultant
Weirsdale FL
United States
------------------------------