Cayuse Step-by-Step Instructions

Resources for Researchers

Creating a New Study

As an IRB Researcher, you can create a new study within Cayuse IRB from your Dashboard or the Studies page.

Creating a Study

Click in the upper right-hand corner of your Dashboard or the Studies page. Enter the title of your study. 

Click to save your study. Afterwards, you will be taken to the Study Details page.   The person who creates the study is added by default as the primary contact. 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

Once you’ve created a new study, you can begin completing forms for your initial submission by clicking first on New Submission, and then Initial from the drop-down menu. Submission information will populate beneath the Submission Details tab. The person who creates the study is added by default as the primary contact, but this can be changed when editing the submission. Make sure to not remove yourself from all roles, or you will not be able to access your submission once you leave. Click on to begin your submission forms. You will always be able to return to an incomplete submission by clicking this button. On your initial submission form, you can return to the Submission Details page by clicking on Study in the upper left-hand corner of the screen. Use the buttons to toggle between sections. You can also click on a section name in the menu at left to jump to that section.

Completing Submission Forms

There are several types of questions that you may need to answer on the submission forms:

• Radio Buttons: Select one of the available options.
• Check Boxes: Select one or more of the available options.
• Date Picker: Click within the field to browse for a date.
• Text Box: Provide a short answer to the stated question (200-character limit). If you need to enter multiple lines of text, the box will expand to fit.
• Text Area: Provide a detailed answer to the stated question. You can use formatting such as bold, italics, underline, strikethrough, bulleted lists, numbered lists, and hyperlinks. You can also add PNG or JPG images using the image button . Once your image is inserted, you can edit the image by clicking on the image and then clicking Edit.
• Person and Sponsor Finders: While every initial submission will require you to add a Primary Contact and Principal Investigator, you may have to add other people or sponsors to different sections within your submission. Click on the finder button to bring up a search dialogue. Search for the individual or sponsor that you wish to add, select them, and click Save.
• Attachments: Upload one or more files to the study by clicking .Cayuse IRB supports the following file types: You can also include hyperlinks as “attachments” by choosing Add Link from the + drop-down menu. To delete an attachment, click the icon next to the attachment.

Saving Your Changes

Sections with unsaved changes have an asterisk next to the section name. To save your changes, click in the upper right-hand corner.

Help with Questions

If there is help text for a question, you can click on the button to view it. Once there are green check marks next to all of your sections, you have completed the submission forms and are ready for routing. With every section completed, you can complete your submission and send it to the PI for certification. Please note: Cayuse IRB will warn you with a red lock icon if another user is currently editing a section. You won’t be able to edit that section until that person is done making edits.

Completing a Submission

The Complete Submission button will appear only when you have green check marks next to all of your sections. If one of your sections doesn’t have a check mark, 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.

Certification

Your completed submission is sent to the PI for certification. The PI will be notified by email. 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 it, the submission will be reviewed by the organizational approver, if any, and then routed to the IRB Analyst. The submission may be returned at any point for edits or clarification. Completing Submission as a PI: If you are a PI completing your submission, you should be able to then certify it 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 on the button within Submission Details.

Submission Routing

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 > 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.

Addressing Comments

You must mark all comments as addressed before the submission can be completed. Once all comments on the submission have been addressed and it has been completed, the PI will need to re-certify the submission to return it to the IRB Analyst.

• Click on the numbered comment bubble to view the unaddressed comments associated with each question.
• Click Reply. Enter your reply and click Save.
• Once you have resolved an issue, change the status drop-down from to .

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.   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.