1. How to Submit an Amendment
Office of Research Compliance v2-2017

2. 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.
Office of Research Compliance v2-2017

3. Copy and Paste to Log in to Cayuse: https://cpp.cayuse424.com
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4. Select your study
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5. You’ll be taken to this page
You’ll be taken to this page. Click on the blue button for “New Submission.”
Office of Research Compliance v2-2017
Office of Research Compliance v2-2017

6. Modification = submitting a change or amendment to the protocol
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
Select Modification
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7. You’re taken to this page.
Click on “Edit” to provide details about the submission to the IRB.
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8. 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.
Office of Research Compliance v2-2017

9. 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.).
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10. 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.
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11. 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.
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12. 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).
Office of Research Compliance v2-2017

13. 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).
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14. 1. Type in your co-PIs name
2. Select your co-PI from the list, then click on “save”.
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15. 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
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16. 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.
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17. 1. Once every section has a green arrow and have finished with your amendment/modification, scroll down and click on “complete submission”.
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18. You’ll be redirected to this page
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).
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19. Read and select “Confirm”.
Office of Research Compliance v2-2017

20. 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 confirmation of the action and submission type you did.
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21. If you have any issues or questions, please contact the IRB Office: or (909) (Bruce Kennedy) or (909) (Desiree) and for IRB document examples and links, visit our website at protocol.shtml
As this is a new IRB system, if you find any issues (typos, unclear questions, etc.) please let us know!
Office of Research Compliance v2-2017