How to Submit an
Amendment
How to use this tutorial
• This tutorial is for researchers (PIs) who already have an approved IRB protocol and
wish to submit an amendment/modification.
• If the protocol has not been reviewed and approved, then the researchers can submit
a withdrawal type protocol. That process is similar to what is described here; the
details are at the end of this tutorial.
• In Cayuse, the first protocol is known as the “initial” study. It can also be called “de
novo,” “new,” “draft” while it is being written and developed, and “under review” by
the IRB (both the office and the Board members).
• Before approval, PIs can withdraw their protocol from further review. Once approved,
then the protocol can be amended/modified, renewed, or closed.
• Use your keyboard’s left/right/up/down arrow (or your mouse/trackpad scroll or the
spacebar) to move through the PowerPoint. Instructions are animated.
Copy and Paste to Log in to Cayuse:
https://cpp.cayuse424.com
Select your study
You’ll be taken to this page. Click on the blue
button for “New Submission.”
Select Modification
Renewal = extending the study for up to a year,
before the approved protocol expires.
Modification = submitting a change or
amendment to the protocol
Incident = reporting an adverse event
Closure = you are finished collecting data for the
study
You’re taken to this page.
Click on “Edit” to provide details about the submission to the IRB.
1. See that you have all of your original
protocol sections (blue) plus two new
sections at the top (red).
2. Any changes you are submitting must be
changed within the protocol (blue). You will
also need to complete the first two sections
(red). The first two sections provide the IRB
with a brief summary of the changes, then the
actual changes within the blue sections,
modify the protocol.
1. If you are adding or removing study
personnel, follow these instructions.
2. First, complete the top 2 sections (red). The
first question asks if you are adding or
removing study personnel. Click yes if you are
(this includes research assistants, co-PIs, PIs,
etc.).
1. If you click “yes”, a text box will open and
here you will explain the personnel changes.
This example shows you the addition of a
research assistant.
1. If you click “yes”, a text box will open and
here you will explain the personnel changes.
This example shows you the addition of a co-PI.
1. After you complete the first two sections
(blue), you will need to go back into the
protocol sections and make the changes. For
this example, we are adding research assistants
which are in the personnel section (red).
1. For this example, we are adding a co-PI (red),
also in the personnel section.
2. To add a co-PI, look for the co-PI section and
click on “Find People”. A pop-up will appear on
your screen (next slide).
1. Type in your co-PIs name
2. Select your co-PI from the list, then click on
“save”.
1. If you are making changes to other parts of
the protocol (methods, consenting, etc.),
please provide us with a brief summary of the
changes here
1. Make sure you attach your updated
documents here (red box) and update them
within the protocol (blue). We ask you to
update them in both places to make the
review process easier.
1. Once every section has a green arrow and
have finished with your
amendment/modification, scroll down and
click on “complete submission”.
You’ll be redirected to this page. You will need to
“Certify” in order to finalize the submission.
Certification says you knowingly mean to take this action
(to renew, amend/modify, or close).
Read and select
“Confirm”.
After you have certified, the submission details
page should look like this. Notice that the study
protocol is “Under Pre-Review” which means it’s
with the IRB office. You and any co-PIs should
receive an email confirmation of the action and
submission type you did.
If you have any issues or questions, please contact the IRB
Office: [email protected] or (909) 869-4215 (Bruce Kennedy)
or (909) 869-3713 (Desiree) and for IRB document examples
and links, visit our website at
http://www.cpp.edu/~research/irb/getting-started-with-aprotocol.shtml
As this is a new IRB system, if you find any issues (typos, unclear
questions, etc.) please let us know!