Transition & Timeline FAQs
What is backfilling the application form and how do I do it?
“Backfilling the application form” means that the PI completes all questions in the protocol shell. This is done by creating an amendment in Cayuse so that the form is editable and then completing all sections of the application form.
I have a deferral in LEO. How does the transition to Cayuse impact me?
Deferrals will not be migrated to Cayuse. If you want to continue working on the project after the expiration date in LEO, you will need to resubmit in Cayuse.
What is a ‘PI Group’ and how do I request this?
A ‘Principal Investigator Group’ is one or more study team members that can assist the PI by creating and submitting submissions to the IACUC. NOTE: The PI must still sign off (i.e., certify) before the submission will be routed to the IACUC for review.
To request a PI Group, please email compliance@ohio.edu with the study number and names of research team members to add to the group.
If your study exists as a protocol shell, you must first backfill the application form. This is because only the PI's name has been included in the protocol shell.
Scenario 1: How do I submit a new protocol (not previously approved in LEO) for review?
Transition Plan for Scenario 1: In this case, you will need to start a new protocol application in Cayuse. For more information, please refer to How to Create a New Submission. Please be sure to consult with the IACUC Meeting Schedule, your new protocol will need to be reviewed at a convened meeting. Be sure to submit your protocol before the submission deadline for the meeting you are targeting.
Scenario 2: How do I amend/modify an existing LEO protocol that’s in Cayuse?
Transition Plan for Scenario 2: Before submitting an amendment in Cayuse, you must first backfill your Cayuse protocol shell. A protocol shell has been created for you in Cayuse, accessible only by the PI of the protocol.
The backfilled protocol shell must be reviewed and approved before you can submit an amendment, with the exception of personnel additions or removals being allowed in the backfill. The backfilling step is essential, protocol shells are incomplete in terms applicable sections and content. The shell must be fully backfilled with all the protocol's components to ensure that the elements of the amendment can be properly incorporated.
This review can occur outside of the IACUC convened meeting, so please allow 3 business days for the review process. Once the backfill is approved, you can create and submit an amendment for review. Please be sure to consult with the IACUC Meeting Schedule, your amendment will need to be reviewed at a convened meeting. Be sure to submit your amendment before the submission deadline for the meeting you are targeting.
For detailed instructions on how to backfill a protocol shell, refer to the guide linked below. Once your backfilled submission is reviewed and approved, you can proceed with submitting an amendment. Please refer to the guide linked below for further information.
Step 1. How to Backfill a Protocol Shell
Step 2. How to Create an Amendment
Scenario 3: How do I report a deviation or adverse event?
Transition Plan for Scenario 3:
- If you have already backfilled your protocol shell in Cayuse, please submit an amendment to provide the IACUC with information about your deviation and or adverse event. For more information, please refer to How to Submit a Deviation or Adverse Event Report
- If you have NOT backfilled, you protocol shell in Cayuse. Please report the deviation/adverse event promptly via email compliance@ohio.edu. Please see IACUC Interim Procedure 001: Managing Noncompliance and Animal Welfare Concerns for more information.
Note: Researchers who report an adverse event or deviation through the interim process are required to complete the backfill of their submission within 30 days of the initial report. During this backfilling process, researchers must incorporate the details of the report into their final submission.
Scenario 4: My protocol is expiring soon. How do I renew?
Transition Plan for Scenario 4: To renew your protocol, you need to submit a De Novo (i.e. a renewal) form in Cayuse. Please be sure to consult with the IACUC Meeting Schedule because your De Novo submission will need to be reviewed at a convened meeting. Be sure to submit your protocol before the submission deadline for the meeting you are targeting. To avoid a lapse in approval, please be sure to strive for an IACUC meeting date that is two months before your protocol’s expiration date.
- If you have already backfilled your protocol shell, please go ahead and initiate the De Novo submission. If you need assistance, please contact compliance@ohio.edu.
- If you have NOT backfilled your protocol shell, you can initiate the De Novo submission, however, you will need to budget additional time to completely fill in the protocol shell with information. To do so, after you complete the De Novo form questions, you will need to then navigate to the “Options” section of the protocol form and make selections to open up additional sections for editing. This step is similar to completing a new protocol submission so please budget your time accordingly. Again, if you need assistance, please contact compliance@ohio.edu.
How to Submit a De Novo: Contact compliance@ohio.edu for instructions.
Scenario 5: I do I submit a Continuing Review due in Cayuse?
Transition Plan for Scenario 5:
- If you have already submitted an Annual Report in LEO in 2025, you do not need to submit a Continuing Review in Cayuse. Administrative staff will reconcile the Continuing Review for you.
- If you did NOT submit an Annual Report in LEO in 2025, please complete the Continuing Review by the due date or if the due date has passed, as soon as possible. Please be aware that Continuing Reviews are reviewed outside of the IACUC Convened Meeting. For more information on submitting a Continuing Review, please see How to Submit a Continuing Review.