The IRB/IBC/IACUC/Dive number is created at initial review by the system automatically. This number is tied to the overall study.
The reference number is tied to an individual submission for the study. A reference number is created when submissions, like an amendment, reportable event, continuing or annual review, are drafted.
“Create a New Study” begins a new application. This should be used for your initial submission.
“Start a Study Submission Form” is used when you need to submit a continuing review, amendment, or reportable event to an existing approved study.
Once you are done completing the last section of the study application, you will automatically enter the submission packet where you will attach any documents to the application.
When you click add consent for, you will be presented with a few options on how to create the consent form. One option is to use the consent builder. The consent builder takes our template and uses merge code from your application to auto fill a draft document. For example, it will take the information from the user profile for the PI added to the submission and pre-populate their name and contact information in the Who to Contact section of the informed consent template.
The Initial Review Submission Packet “packages” the Application and documents together for submission. As you progress through the submission packet you will see the IRB Application form you just filled out and then will be prompted to attach various study documents.
"Add a New Consent" in the Informed Consent section.
"Add New Document" or "Add Multiple Documents" in the "Study Documents" section.
You can view your submission progress from the Study Assistant Dashboard.
Click the paper/pencil icon to reopen the Study Dashboard and continue editing your submission.
Select "Sign off and Submit" to open the PI Attestation Page.
Note: Only the Principal Investigator can execute the sign-off and submit action.
If you are not the PI, the page will instead show an option to notify the PI to signoff.
The PI will receive a notification and task on their dashboard alerting them to sign off. Once the PI signs off then the submission will route to the IRB assignment queue.
