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IRB Frequently Asked Questions

Researcher Dashboard Overview Video

IRB Researcher overview video:

Frequently Asked Questions

Creating a Study

  1. As an IRB Researcher, you can create a new study from your Dashboard or the Studies page within Cayuse IRB.
  2. Click "New Study" in the upper right-hand corner of your Dashboard or the Studies page.
  3. Enter the title of your study. The title can be up to 600 characters long
  4. Click checkmark box to save your study.

After creating your study, you will be taken to the Study Details page. Here, you will see where important study information will populate once you begin your submission.

The person who creates the study is added as the primary contact by default. You can change this when editing the submission.

You can rename your study up until the completion of a withdrawal or admin closure submission. From the Study Details screen, hover over the study title and click within the field to edit.

Once you create your study, you can begin your initial submission. Click on New Submission in the upper right-hand corner to start completing your forms.

Creating an Initial Submission

The Complete Submission button will only appear when you have green check marks next to all of your sections,. If one of your sections doesn't have a check mark and you aren't sure why, click on the section to search for any required questions you may have missed.

Once you have filled out every section of your submission and have added all required attachments, a Complete Submission option appears beneath Routing within the menu.

After clicking Complete Submission, you will be prompted to Confirm or Cancel.

Upon confirmation, you will see the status of your submission change on the Submission Details page.


Your completed submission is sent to the PI for certification. The PI will receive an email letting them know that the submission needs to be certified. When the PI certifies the submission, they are asserting the submission is complete and accurate and are accepting their PI responsibilities.

If the PI decides that changes need to be made, they will send the submission back. All research team members will receive an email notifying them of the change in status so they can make the necessary edits and complete the submission once more.

Once the PI has certified the submission, the submission will be reviewed by the organizational approver and routed to the IRB Analyst. The submission may be returned at any point for edits or clarification. Please note: If your institution does not have an approver, the submission may be routed directly to the IRB Analyst.

Completing Submission as a PI: If you are a PI completing your submission, you should be able to then certify the submission right away.

Co-PIs: Your institution's settings may require that any Co-PIs on the study also certify the submission. These individuals also have the ability to return to the submission to the research team. IRB Administrators can specify this behavior in the Application Settings.

Recertification: If the submission does get returned to the research team, all previous certifications are cleared. All individuals who were required to certify the submission in previous rounds of routing must recertify every time the submission is returned before it can move forward.

Reopening Your Submission

To reopen the submission and make edits, click "Edit" on the button within Submission Details.

Viewing and Downloading Letters

During the submission process, the compliance office may send communication to the PI in the form letters notifying the PI of status changes, approvals, and needed information. Letters are sent via email and are available to download directly from Submission Details in Cayuse IRB.

The Letters tab appears for a submission when there is at least one letter associated with that submission. To view a letter, click on the letter tab.

You will be able to view the subject, send date, and recipient(s) for each letter. You can click anywhere on the line to open a PDF of the letter in a new window.

To save the letter to a file:

  • Chrome: Right-click within the opened PDF and select Save As.
  • Firefox: Right-click within the opened PDF and select Save Page As.
  • Internet Explorer: In the menu bar, click on settings icon > File > Save As.

Addressing Comments

When a submission has been certified by a PI and sent to the IRB Analyst, the Analyst or other individuals reviewing the submission may comment on various questions within the submission forms. The Analyst will return the submission to the investigators, and the investigators will need to address any of the comments.

Sections with unresolved comments have a comment bubble icon indicating the total number of unresolved comments in that section. Click on the section to see which questions have a comment attached.

Depending on how far the submission progressed, you may see comments from the IRB Analyst, your Organizational Approver, or from the IRB member(s) reviewing the submission.

  1. Click on the numbered comment bubble to view the unaddressed comments associated with each question.
  2. Click Reply. Enter your reply and click Save.
  3. Once you have resolved an issue, change the status drop-down from "Not Addressed" to "Addressed".

You must mark all comments as addressed before the submission can be completed.

Once all comments on the submission have been addressed and the submission has been completed, the PI will need to re-certify the submission to return it to the IRB Analyst.

Viewing Submission Details and History

You can access all details and history for a submission within the Submissions tab on the Study Details page, or from the menu on your Dashboard.

From Study Details

From the Study Details page, click on the Submissions tab.

The Submissions tab shows the list of submissions associated with the study, including the submission type, review type and status, decision, and last modified date. Click on the submission you wish to view.

At the bottom of the Submission Details screen, you'll see tabs that vary depending on the submission stage. Tabs may include Approvals, Task History, Letters, Meetings, Decisions, and Linked Proposals.

Click on the desired tab to locate the required information.

From Your Dashboard

Click on Submissions in the menu.

Search for the submission you wish to view, and then click on the submission.

This will bring you to the Submission Details page.

Understanding Submission Types

When you first create a study, you also create the initial submission outlining the purpose of that study by clicking on "New Submission on the Study Details page.

In addition to this initial submission, there are five other types of submissions that you may submit during the course of your research.

Please note: Each submission type has its own template that the IRB Analyst or Admin needs to configure via the Manage Submission Templates page before the submission type can be created.

Available Submissions Types:

  • 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.
  • 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.
  • Renewal: When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. The renewal will need to be approved before you can continue with the study.
  • Incident: You must submit an incident report to inform the Compliance 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.
  • Withdrawal: A withdrawal submission notifies the 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 has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research.
  • 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.
  • Legacy: Used for studies imported from previous systems. The legacy submission replaces the initial submission for imported studies. Once the legacy submission is finalized, you can create additional submissions such as modifications, renewals, etc. An IRB Analyst must create and publish a legacy template before users can create legacy submissions or work with studies that have been imported from other systems.

Submission Types Available to IRB Analysts and Admins:

  • Admin Closure: Allows a study to be administratively closed when needed, for example when the PI leaves the institution or chooses to let a study expire.
  • Admin Withdrawal: Allows a study to be administratively withdrawn when needed, for example when the PI leaves the institution.