IRB Basic Steps
after approval: Submitting a modification, renewal or closure
After a PI has received an Initial approval for their study, they will be able to resubmit the study for either a Modification, Renewal, Incident or Closure. More information on all submission types available in Cayuse IRB can be found below in the Cayuse IRB Submission Types tab.
In addition, all Expiration and Renewal Notices are emailed through the Cayuse IRB production site. Cayuse IRB will send reminder notices 60 and 15 days before a protocol expires, so that the PI(s) have adequate time and opportunity to renew the expiring protocol.
NOTE: It is the PI's responsibility to renew his/her protocol before it expires.*
Cayuse IRB Submission Types
When you first create your study in the system, you are creating the Initial Submission for the protocol. In addition to the Initial Submission, there are five other types of submissions that you may submit during the course of your study. The additional submission types include:
Initial- This is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin. For additional guidance, access the step-by-step instructions for Cayuse IRB: Initial Submission (user guide)
Withdrawal- A withdrawal submission notifies the Research Compliance Office that you no longer wish to submit your initial submission and want to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved. If the initial submission had been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Withdrawal Notification
Modification- If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes. Modifications will only be available after initial approval is issued. Modifications will be linked with the initial application and you will make revisions to the initial application based on the modifications you are requesting. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Modification
Renewal- When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. Expiration notices will be emailed from Cayuse. Renewals, like modifications, will only be available after initial approval is issued. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Renewal
Incident- You must submit an incident report to inform the IRB Office of any adverse incidents, as required by your institution. Incident reports may be submitted at any time after a study has been approved, including after it has been closed. More than one incident report may be created for a given study, as needed. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting an Incident Report
Closure- A closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Closure Request
