IRB: OneAegis Application, Amendment, and Submissions

On the left of your screen you will see:  Actions, Recent Items, and My Documents & Forms:

User Settings

The first time you log into OneAegis, please complete your user information. In the upper right corner, select your name.

Select Change My Profile to update your name, prefix, suffix, and degree information. Please update My Phone Number(s) and My Address(es) to provide your contact information.

You can begin entering a new project by selecting Click Here to Start a new IRB Initial Protocol Submission below Actions on the left side of the dashboard:

If you have an existing duplicate submission, you will get a warning that there is a submission currently in progress:

Under My Projects on the dashboard, you can view any study with which you are associated. You can go directly to the study by clicking on the project number.  

To add collaborators such as a PI, Co-PI, or other team members so that they can view or edit the protocol submission, see the Adding Collaborators page.

Throughout the data entry process, you will see NOTES in red. These are to assist you with navigating as well as providing helpful information.

You can navigate through the sections of the protocol submission by selecting the drop-down menu at the top of the page:

After entering your protocol information, you will need to sign your submission by entering your password and clicking Next.

***THIS DOES NOT SUBMIT YOUR PROJECT

You will then see Form Completed and you will need to click Submit:

An Amendment Application is required to report changes in research activities that occur during the approval period for projects reviewed and approved by the Alabama College of Osteopathic Medicine’s IRB.

• From the Dashboard, under the section titled My Projects, click on the study for which the Amendment is required.

• On the left side of the screen, under Actions, click on Start xForm

• Click IRB Request to Amend Approved Protocol

• Complete each section of the Amendment application and click 

Note: If any of the changes in personnel affect the study documents, these must be revised and submitted.

•  From the Dashboard, under the section titled My Projects, click on the study for which the Progress Report is required.

• On the left side of the screen, under Actions, click on Start xForm

• Click IRB Progress Report Application

• Complete each section of the Amendment application and click 

Note: If there have been changes to the research personnel, a Request to Amend Protocol form must be submitted AND approved by the IRB PRIOR to starting the Progress Report xForm.

• An Unanticipated Problem/Adverse Event Form is required to report events that are related, unanticipated and places research subjects (or others) at a greater risk of harm than previously known or expected.
• From the Dashboard, under the section titled My Projects, click on the study for which the reportable event is required.

• On the left side of the screen, under Actions, click on Start xForm

• Click Unanticipated Problem/Adverse Event Form

• Complete each section of the Reportable Event form and click