Cayuse IRB Creating and Submitting additional submissions OFFICE

Cayuse IRB Creating and Submitting additional submissions OFFICE

Cayuse IRB Creating and Submitting additional submissions OFFICE OF RESEARCH INTEGRITY How to use this tutorial This tutorial is for researchers (PIs) who already have an approved IRB protocol and wish to submit a renewal, modification, incident (adverse event) or closure. 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 keyboards left/right/up/down arrow (or your mouse/trackpad

scroll or the spacebar) to move through the PowerPoint. Instructions are animated. OFFICE OF RESEARCH INTEGRITY Before You Begin an IRB Protocol Make sure you have the following items ready*: Supplemental documents in individual document files (i.e. informed

consent form(s), authorization(s), recruitment documents, questionnaires, etc.). Files can be in various formats (PDFs, docx) however doc. (Microsoft Word) files are preferred. Faculty advisor and co-PI(s) CITI training copy of certificate. Ensure that you and your co-PI(s) have been authenticated with the IRB office. If you are unsure, contact the IRB office at [email protected] *You do not have to finish the IRB protocol in one sitting. All information can be saved.

OFFICE OF RESEARCH INTEGRITY Log in to Cayuse: https://chapman.cayuse424.com/ OFFICE OF RESEARCH INTEGRITY Once logged in, youre

first taken to this page. Click on Cayuse IRB (Human Studies Compliance) OFFICE OF RESEARCH INTEGRITY After clicking Cayuse IRB, you will be taken

to your Dashboard where you can see all of your affiliated studies Select your study OFFICE OF RESEARCH V1-2017

Youll be taken to this page. Click on the blue button for New Submission. OFFICE OF RESEARCH V1-2017 Select the type of submission you want to

complete. OFFICE OF RESEARCH V1-2017 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 or unanticipated problem Closure = you are finished collecting data for the study Youre taken to this page. Click on Edit to provide details about the submission to the IRB.

OFFICE OF RESEARCH V1-2017 Fill out the protocol. Remember this is not the same as the initial protocol you did before. When you are finished, click on Complete Submission. OFFICE OF RESEARCH V1-2017

Youll 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 V1-2017 Read and select Confirm.

OFFICE OF RESEARCH V1-2017 After you have certified, the submission details page should look like this. The study protocol is now Under PreReview which means its 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 V1-2017 For a withdrawal . X OFFICE OF RESEARCH V1-2017 For a withdrawal, your not-yet-approved study

protocol wont appear in the Xd box. Find it in the box with the red arrow. Then select Withdraw from the New Study tab and follow the processes. If you have any issues or questions, please contact the IRB Office: [email protected] or (714) 6282833 and for IRB Consent Templates and links, visit our website at https:// www.chapman.edu/research/integrity/irb/forms-an

d-instructions.aspx As this is a new IRB system, if you find any issues (typos, unclear questions, etc.) please let us know! OFFICE OF RESEARCH INTEGRITY

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