Advisory Review

To submit an advisory review submission to the IRB, complete the following steps:

1. Click the Begin button on the right-hand side of the Advisory Review description. The submission forms are displayed.
2. On the initial form, click the checkbox to acknowledge that you're only seeking advisory/consult review and not regulatory IRB approval.
3. Click Save & Next.
4. On the following form, enter the protocol title (required), protocol number, and sponsor (required) in the applicable fields.
5. Click Save & Next.
6. On the next form, identify the submission’s team members by clicking the Add Team Member button. (In the first right slider that opens, you must click the Add Team Member button a second time to select a team member.) In the second right slider that opens, you can search for a team member by using the Name, Email, or Organization drop-down filter, entering a search term, and then clicking Apply. To select a user, click the radio button by their name and then click the Close button. Back in the first right slider, you must indicate the submission role, editing permissions, and contact preferences for the team member you selected. To save and finish, click the Add This User button. To save and then add another user, click the OK and Add Another button.

   • If the team member has a CIRBI account but is not within the same organization as you, you can enter their full email address in the provided field.

     

   • If the team member doesn’t already have a CIRBI account, you won’t be able to add them to the submission until they create one. They can create an account using the steps outlined on the Registration page.
   • Refer to the Edit Contact and Notifications/Edit Site Contacts section in the Submission Actions topic for more information about this workflow.
7. Identify the submission’s primary point of contact by clicking the Add Primary Contact button. In the right slider that opens, you can search for points of contact by using the Name, Email, or Organization drop-down filter, entering a search term, and then clicking Apply. To select a user, click the radio button by their name and then click the Close button.
8. Enter invoice recipient and purchase order information in the bottom half of the form. You can optionally upload purchase order-related documentation by clicking the Add Document button.
9. Click Save & Next.
10. On the following form, select the considerations you want the IRB to focus on as part of their review. In the Additional Details section, enter any other details you want the IRB to consider as part of their review. Lastly, select where the expected sites will be located. All fields on this form are required.
11. Click Save & Next.
12. On the final Document Upload Page form, upload any applicable supporting documents or information such as protocol documents, recruitment material documents, informed consent form documents, and device profiles in each labeled tab. You can expand the tab for each document type by clicking the (+) button on the tab, or expand all tabs by clicking the Expand All button.
    • To upload a document in an expanded tab, click the Add Document button, drag and drop or browse for the document from your computer, answer the displayed questions about the document, and then click the Add or OK & Add Another button.
    • To add a profile for a drug, cosmetic, or device in an expanded tab, click the Add [record] button, enter profile information, and then click the Add or OK & Add Another button.
13. Click Save.
14. Click Submit.
15. In the window that appears, click Submit Application.

After your submission is created, you can:

• Refer to the General Submission Process Information page for general information about the submission creation process and next steps after creating a submission.
• Refer to the Submission Workspace page to learn about the information you can view about your submission after you've submitted it.
• Refer to the Submission Actions page for more information about the actions you can take on your submission after you've submitted it.