How to Submit an Amendment Office of Research Compliance 2018

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. 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 2018

Copy and Paste to Log in to Cayuse: https://cpp.cayuse424.com Office of Research Compliance 2018

Select your study Office of Research Compliance 2018

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 2018 Office of Research Compliance v2-2017

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 Office of Research Compliance 2018

You’re taken to this page. Click on “Edit” to provide details about the submission to the IRB. Office of Research Compliance 2018

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 2018

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.). Office of Research Compliance 2018

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. Office of Research Compliance 2018

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 2018

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). Office of Research Compliance 2018

1. Type in your co-PIs name 2. Select your co-PI from the list, then click on “save”. Office of Research Compliance 2018

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 Office of Research Compliance 2018

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. Office of Research Compliance 2018

1. Once every section has a green arrow and have finished with your amendment/modification, scroll down and click on “complete submission”. Office of Research Compliance 2018

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). Office of Research Compliance 2018

Read and select “Confirm”. Office of Research Compliance 2018

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. Office of Research Compliance 2018

If you have any issues or questions, please contact the IRB Office: irb-office@cpp.edu or (909) 869-4215 (Maya) and for IRB document examples and links, visit our website at http://www.cpp.edu/~research/irb/getting-started-with-a- protocol.shtml Office of Research Compliance 2018