1. Cayuse IRB USER guide Villanova University
Version: February 2019

2. Cayuse IRB Basics
The Villanova IRB uses an online protocol management system called Cayuse IRB for all applications, modifications, notifications, and other official communication about human subjects research.
Cayuse IRB is separate from other Cayuse services used for submitting grant materials, but run by the same company.
To be granted access to Cayuse, fill out the Cayuse Request Form available on the IRB website.
Anyone can have an account, but only faculty, post-docs, and PhD students may be Principle Investigators on applications.

3. Getting started: Logging on1.
Logon URL: 2.
Sign on with your Villanova credentials 3.
Select “Cayuse IRB”

4. Getting started: Dashboard
Each time you log on you will be brought to your “dashboard” page that allows you to navigate to other areas of the site.
Your Name
Study Title
This top pane summarizes the status of your submissions
Click on the “bell” to access any notifications (e.g. study tasks or decision notices)
The “My studies” widget displays all of your active submissions
Any pending tasks appear here
Any approved studies appear here
Soon to expire studies appear here
Expired studies appear here

5. Getting started: Creating a new study1.
Your Name
The blue “+ New Study” button in the upper right corner will allow you to create a new submission. 2.
Clicking that button will bring you to the study details page.
Type your study name and click the blue check box.
You cannot easily change this title later on, so be sure about what you select.

6. Getting started: Creating a new study
Your study status will be highlighted here.
Your Name
Study Title 1.
To access the full application, click on the “+ New Submission” button, and then select “Initial”.
Your study will be assigned a protocol number. This number will be used for the entire life of your protocol. 2.
Click on “Assign PI”, which will lead you to the full application.

7. Getting started: Creating a new study
The interactive form will offer different questions depending on which answers you select.
Study Title - Initial
Optional: Use the menu on the left to navigate through your submission.
All personnel (including students) listed on your application must have completed all required CITI trainings and FCOI disclosure form. See irb.Villanova.edu for list.
Move your way through the form. You may save and return later if needed. You will need to include information about your study background and rationale, design, measures, etc.
Note: Cayuse does not auto-save!

8. Getting started: Creating a new study
The task bar on the left side of the screen will mark your progress through the application.
A green check mark shows that all required questions in that section have been answered.
Once all sections are complete, you will see a new option to Complete your submission. Once you do, it will be sent to: 1.) PI and co-PI(s) for certification,
2.) Selected person in your department who handles approval (e.g. dept. chair, dean),
3.) ORP for pre-review to verify completeness

9. Continued use: Replying to reviewer comments
In many cases your application will be returned to you for changes before it is approved.
Sections with reviewer or analyst comments will be highlighted in the sidebar.
You can locate the “expand comments” bubble to view and respond to requests.
Mark comments as “addressed” when you have done so.

10. Modification submission
You must seek IRB approval for modifications to your protocol including personnel changes, updates to your study instruments, or recruitment materials, etc. For exempt studies, see your determination letter for instructions about when a modification is necessary. 1.
Login to Cayuse IRB and click on the study you wish to modify. 2.
Click on “New Submission” and select “modification” from the drop down list. 3. 4.
When the application is complete the routing and “complete” buttons will appear in the sidebar to finalize.
Complete the modification cover page and make any necessary changes to the body of the main application.

11. Login to Cayuse IRB and click on the study you wish to renew.
Renewal Submission
Annual Renewals (full board studies/clinical trials) or Status Update Reports (expedited studies) must be completed each year before your expiration date 1.
Login to Cayuse IRB and click on the study you wish to renew. 2.
Click on “New Submission” and select “Renewal” from the drop down list. 4.
When the application is complete the routing and “complete” buttons will appear in the sidebar to finalize. 3.
Complete the Status Update Report or Annual Renewal form depending on your study’s review level.

12. Login to Cayuse IRB and click on the study you wish to close.
Closure submission
Close your study when you have completed all enrollment, data collection, data analysis, and manuscript preparation. 1.
Login to Cayuse IRB and click on the study you wish to close. 2.
Click on “New Submission” and select “Closure” from the drop down list. 3. 4.
Complete the closure report affirming that you have completed work on the study.
When the form is complete the routing and “complete” buttons will appear in the sidebar to finalize.

13. Complete the incident report, providing as much detail as possible.
Notify the IRB via an incident report if there are any unanticipated or adverse events during the course of your study activities. This includes any deviation from your approved protocol. 1.
Login to Cayuse IRB and click on the study on which you wish to report. 2.
Click on “New Submission” and select “Adverse Event” from the drop down list. 4.
When the form is complete the routing and “complete” buttons will appear in the sidebar to finalize.
The IRB will contact you with any further information or action requests 3.
Complete the incident report, providing as much detail as possible.

14. Getting started: Workflow
PI creates protocol
PI submits protocol
Protocol is routed for Organizational Approval
ORP is not notified of your application before this point
ORP receives protocol and conducts pre-review
Protocol is returned to PI for revision or training issues
Protocol is sent to reviewer
PI returns protocol to ORP after revising
Protocol Approved
Reviewer has up to two weeks to review initial submission. Most applications (aside from full board studies) are approved within this two week period.

15. CONTACT:
irb.villanova.edu
Kaitlin Gottuso Compliance Specialist, ORP (Office) Rani MuthukrishNan Director, ORP (office) Suzanne Smeltzer Chair, IRB (Office)

16. Appendix: More information

17. Helpful Hints
Cayuse does not auto-save your work! Be sure to manually save often.
Applications are sent to reviewers on Fridays in a “batch”.
Any complete application that is received by Thursday at 2pm will be included in the weekly batch.
Be sure to allow time for organizational approval if you are trying to meet the Thursday deadline.
All communication about your study (confirmation of receipt, decisions, expiration notices) will come in writing via from

18. Helpful Hints
You can find monthly deadlines for the submission of protocols that will undergo Full Board review on the ORP website.
You can delete protocols that have not yet been submitted from the “submission details” page. Anything that has already been submitted must be withdrawn or closed.
Applications cannot be duplicated for ease of creating new protocols.
As a workaround, on the “submission details” page you can create a PDF of your application from which you may copy/paste.

19. Submission process
Once your protocol is submitted, ORP will verify that CITI training and fCOI requirements are up to date for all personnel listed on the protocol.
In certain cases you (PI) will also be able to verify CITI trainings for your research staff before you submit your protocol. This requires your students having a Cayuse account (see first slide).
Then reviewers will be assigned by ORP depending on the level of review required.

20. Workflow PI ORP Reviewer
ORP forwards complete applications to Reviewers on Fridays (if submitted by Thursday at 2pm)
PI submits protocol after completing Cayuse application PI
ORP
Reviewer
Reviewer has up to two weeks to review initial submission. Most applications (aside from full board studies) are approved within this two week period.
ORP will send back to PI with reviewer comments or if submitted application is incomplete
Reviewer decisions (approvals or returns to PI) are sent to PI via ORP

21. IRB Operations: Types of IRB submissions
Initial Review
The first review of a human subjects research protocol.
Modifications
Modifications include changes to already approved protocols, like adding personnel, changing study measures or recruitment strategies.
Annual or Continuing Review
For many studies the IRB conducts an annual continuing review (full board) or status update (expedited) check.
Incident
An occurrence of any protocol violation, noncompliance, deviation, or serious noncompliance that is not consistent with the approved study procedures. For example, enrolling more participants than initially approved in your IRB application.

22. IRB Operations: types of IRB Submissions (cont’d)
Withdrawal
Used to withdraw an application from consideration by the IRB before it is officially approved. For example, when application sent in error or when you decide not to conduct the research.
Closure
Any study where all study procedures have been performed and data collection/analysis is complete.
Administrator Closure
Similar to ‘closure’ but initiated and performed by IRB Administration staff.
Administrator Withdrawal
Similar to a ‘withdrawal’ but initiated and performed by IRB Administration staff.

23. All decisions provided
in writing!
IRB Operations: types of IRB Decisions
Approved: The protocol is approved as submitted and research may begin.
Return to PI/Minor Stipulations: Reviewers will choose either of these decision types when they have identified issues the PI must address and revise before review can be finalized.
Exempt: This determination is given to protocols that meet a specific set of criteria laid out by the federal government.
Not Human Subjects Research: The IRB will sometimes give this determination if the research does not meet the federal definition of human subjects research and the activity is not subject to the regulations. No continued oversight required.