帝王会所

How to Backfill a Protocol Shell

Transition Pathway for Existing LEO Protocols

We are transitioning all active approved IACUC protocols from LEO to Cayuse using a 鈥減rotocol shell鈥 approach. This protocol shell will include only the study title, the Principal Investigator鈥檚 name, and PDF attachments of submissions approved in LEO during the current approval period.

  • Note: To complete this transition, the Principal Investigator (PI) will need to actively participate by backfilling the submission with content from your currently approved LEO protocol. This involves filling out all required sections in the protocol shell to ensure a seamless transfer.

How Do I Backfill a Protocol Shell?

Our office has developed a comprehensive tutorial to demonstrate the backfilling process in Cayuse. This tutorial will guide you step-by-step through completing the backfill process. Key information about this process is also provided in .

Benefits of Using a Protocol Shell Approach

  • Retention of Existing Approval & Expiration Dates: All protocols will maintain their current approval and expiration dates as indicated in LEO.
  • Streamlined Review: Backfilled protocols that contain only existing content that covered under the current LEO protocol do not have the undergo full committee review at a convened meeting. These submissions can be reviewed outside of the convened meeting using Designed Member Review (DMR)

Important Considerations

  • Backfilling is Required: Before any amendments, deviation/adverse event reports, or renewals can occur, the application form must be 鈥渂ackfilled鈥 by the PI.  This involves completing all questions in the protocol shell by creating an amendment in Cayuse to make the form editable and then filling out all sections of the application form.
  • No Changes to Protocols: This transition period is not the time to make changes to the protocol. Only currently approved LEO content should be used for backfilling. 

The Office of Research Compliance is here to assist you, contact us at complianc@ohio.edu or 740-593-0664 if you have any questions about transitioning to Cayuse.