Cayuse IRB: Creating and Submitting Additional Submissions
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 change the study title and 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.
•
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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.
•
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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, you’re 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
You’ll 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.
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OFFICE OF RESEARCH V1-2017
You’re 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
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 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 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 V1-2017
For a withdrawal, your not-yet-approved study protocol won’t
appear in the X’d box. Find it in the box with the red arrow and
select the protocol. Then select “New Submission” tab at the
top of the screen and a drop-down menu with the option
“Withdrawal” appears. Follow the processes.
X
For a withdrawal ….
OFFICE OF RESEARCH V1-2017
After select your study from the dashboard, hover your cursor
over the title on the Study Details page. Clicking in that text box
should allow the study title to be edited. After making any
edits, the change will need to be saved by selecting the blue
checkmark that appears immediately below that field.
OFFICE OF RESEARCH V1-2017
Changing a Study Title…
If you have any issues or questions, please contact the IRB
Office:
irb@chapman.edu
or (714) 628-2833 and for IRB
Consent Templates and links, visit our website at
https://www.chapman.edu/research/integrity/irb/forms-and-
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
This tutorial is for researchers (PIs) with an approved IRB protocol who want to make changes to their study titles and submit renewals, modifications, incidents (adverse events), or closures. Learn about the process in Cayuse, from initial study to amending/modifying, renewing, or closing protocols. Follow step-by-step instructions to navigate through the submission process effectively.
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Presentation Transcript
Cayuse IRB Creating and Submitting additional submissions
How to use this tutorial This tutorial is for researchers (PIs) who already have an approved IRB protocol and wish to change the study title and 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 keyboard s left/right/up/down arrow (or your mouse/trackpad scroll or the spacebar) to move through the PowerPoint. Instructions are animated. Instructions are animated.
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 Ensure that you and your co- -PI(s) have been authenticated with the IRB office. If PI(s) have been authenticated with the IRB office. If you are unsure, contact the IRB office at you are unsure, contact the IRB office at irb@chapman.edu irb@chapman.edu *You do not have to finish the IRB protocol in one sitting. All information can be saved.
Log in to Cayuse: https://chapman.cayuse424.com/
Once logged in, youre first taken to this page. Click on Cayuse IRB (Human Studies Compliance)
After clicking Cayuse IRB, you will be taken to your Dashboard where you can see all of your affiliated studies
Youll be taken to this page. Click on the blue button for New Submission.
Renewal Renewal = extending the study for up to a year, before the approved protocol expires. Modification Modification = submitting a change or amendment to the protocol Incident Incident = reporting an adverse event or unanticipated problem Closure Closure = you are finished collecting data for the study Select the type of submission you want to complete.
Youre taken to this page. Click on Edit to provide details about the submission to the IRB.
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 .
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).
Read and select Confirm .
After you have certified, the submission details page should look like this. The study protocol is now 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.
For a withdrawal . X X For a withdrawal, your not-yet-approved study protocol won t appear in the X d box. Find it in the box with the red arrow and select the protocol. Then select New Submission tab at the top of the screen and a drop-down menu with the option Withdrawal appears. Follow the processes.
Changing a Study Title After select your study from the dashboard, hover your cursor over the title on the Study Details page. Clicking in that text box should allow the study title to be edited. After making any edits, the change will need to be saved by selecting the blue checkmark that appears immediately below that field.
If you have any issues or questions, please contact the IRB Office: irb@chapman.edu or (714) 628-2833 and for IRB Consent Templates and links, visit our website at https://www.chapman.edu/research/integrity/irb/forms-and- instructions.aspx As this is a new IRB system, if you find any issues (typos, unclear questions, etc.) please let us know!
