Introduction

This guide covers how to tell where a study or submission is in the review process within Cayuse. It also covers how to tell when a submission requires action from the PI.

This guide utilizes screen shots instead of .gif images, because the nature of this guide is less dynamic than the other Gif Guides, and screenshots are sufficient for this topic.

Locating a Study or a Submission

In Cayuse, a study is a sort of “shell” that houses all of the submissions related to that study. Submissions can come in a variety of types, including initial submissions, modifications, renewals, incident reports, and closures. But all of these submission types are housed under a study in Cayuse.

There are a few ways to locate a submission in Cayuse. All of these methods begin on the Cayuse Dashboard.

Using the Cayuse Dashboard

The Cayuse Dashboard contains several “bins” that will list submissions or studies based on where they are in the review process. Each bin is described below.

My Studies

This bin will list all of your currently active studies. Clicking on any of the studies in this bin will take you to the Study Details page. From that page, you can access submissions housed under that study.

My Tasks

This bin will list any submissions that require action on your part. The first column in the bin will list the Cayuse-assigned IRB number for the study, and the second column will display the action required. Clicking on the IRB number of any study in this bin will take you to the submission that requires action.

Submissions by Type

This bin contains a list of submission types (i.e.: renewal, initial, modification, etc.) in the first column, and in the second column will display a number representing the number of submissions of that type you currently have. Clicking on any of the submission types in this bin will take you to a list of those submissions.

Approved Studies

This bin will list all studies that are currently in an “approved” state. Clicking on any of the IRB numbers in this bin will take you to the Study Details page for that study. It is important to note that, while a study may be approved, some submissions housed under that study may not yet be approved. For example, a modification submission may be open and under review, and not yet approved, even if the parent study is currently listed as approved.

Expiring Studies

This bin contains any studies that are set to expire soon. The default timeframe is 30 days, so this bin will, by default, display any studies that are set to expire in the next 30 days. Next to the words “30 days” is a dropdown menu icon. If you click on this icon, you can change the timeframe to 60 or 90 days, to display studies that will expire in the next 60 or 90 days, respectively. Clicking on any studies in this bin will take you to the Study Details page.

Expired Studies

This bin will list any studies that have already expired. Expiration of a study means that it no longer has IRB approval. If a study expires, all research activities must cease until a renewal submission is reviewed and approved by the IRB. Clicking on any of the studies in this bin will take you to the Study Details page.

The Studies, Submissions, and Tasks Bar

Above the bins on the dashboard are a few tabs that can be used for navigation. The default tab selection is “Dashboard.” The other tabs are “Studies,” “Submissions,” and “Tasks.”

Clicking on the “Studies” tab will take you to a list of all of your studies that are in any part of the review process.

Clicking on the “Submissions” tab will take you to a list of all of your submissions that are in any part of the review process.

Clicking on the “Tasks” tab will take you to a list of submissions that require action on your part.

Each one of these lists will display the IRB number, the study title/submission type, the status (unsubmitted; under review; review complete, etc.), and may display additional information, such as the PI, the IRB’s decision, and relevant process dates (i.e.: date a submission was routed to the IRB). The additional information displayed depends on the specific list being displayed.

From the “Studies” tab, clicking on the IRB number will take you to the Study Details page. From the “Submissions” and “Tasks” tab, clicking on the IRB number will take you to a specific submission associated with that IRB study number.

Checking Study and Submission Status

Once you have located the study you are looking for, you will view the Study Details page. At the top of this page are two tabs: one that says “Study Details,” and one that says “Submissions.”

The “Study Details” tab is selected by default. When this tab is selected, it displays relevant information about the study, including an approval date, an expiration date, and a list of any active submissions associated with that study.

Below these two tabs will be a status banner. The status banner will change color and text depending on the status of that study. Statuses that might be indicated in the status banner include statuses such as “unsubmitted,” or “approved” (among several other status types). Keep in mind that the status of a study may differ from the status of a submission.

Below is an example of a study with an “approved” status.

screenshot of the Cayuse system displaying an "approved" status in the status bar

Below is an example of a study that is under review.

screenshot of the Cayuse system displaying an "under review" status in the status bar.

From the Study Details page, click the Submissions tab to view submissions associated with that study.

This tab will display all submissions associated with the study, and will display the status of the submission in the Status column.

Click on the submission type name in the far left column to view the submission details.

Once you are on the Submission Details page, you will see a progress bar at the top of the page, above the submission details. The progress bar will indicate whether the submission is:

“In-Draft” – meaning the submission is with you for editing, and is not yet with the IRB
“Awaiting Authorization” – meaning the submission is with the PI awaiting certification. If a submission is in this phase, it is not yet with the IRB
“Pre-Review” – meaning IRB staff currently has the submission and is conducting a pre-review for completeness
“Under-Review” – meaning the submission has been assigned to an IRB member or has been assigned to an upcoming convened IRB meeting (depending on the review type)

Below the progress bar is another status banner. This banner is just like the one for Studies, and will change color and text depending on the status of the submission.

Statuses that Require PI Action

The following statuses that may be listed in the status bar indicate that PI action is required:

Unsubmitted – this status means that the submission has not yet been completed, and also has not yet been routed to the PI for certification
Awaiting Certification – this status means that the PI must complete the certification process for the submission
Reopened – this status means that the submission has been returned to the PI for edits during any point in the review process. Revisions must be made as instructed, and the submission must be completed and certified by the PI once again before it will return to the IRB