Generic Materials

To submit a generic materials submission to the IRB, complete the following steps:

1. Click the Begin button on the right-hand side of the Generic Materials submission type description. The submission forms are displayed.
2. Select the appropriate checkboxes to indicate which listed reviews or services you’re requesting.
3. Click Save & Next.
4. On the next form, identify the submission’s team members and a primary point of contact from your organization by clicking the Add Team Member or Add Primary Contact button. In the right slider that appears, you can search for the team member by using the Name, Email, or Organization drop-down filter, entering a search term, and then clicking Apply. To select the team member, click the radio button by their name and then click the Close 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 to add them to the submission.

     

   • 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.
5. 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.
6. Click Save & Next.
7. If you didn’t request to have Advarra write a draft informed consent form (ICF) for a future study submission, skip to step 10. If you did, continue to step 8.
8. On the next form, enter study sponsor, protocol number, phase, funding, and study type details. Select the most appropriate choices for the consent/authorization type, study population types, and draft risk information questions.
9. Click Save & Next.
10. On the next form, upload documents in each labeled tab. You can expand the tab for each document type by clicking the (+) button or expand all tabs by clicking the Expand All button. To upload a document in an expanded tab, click the Add Document button, click Browse to select a file from your computer or drag-and-drop a file, and then click the Submit Document button.
    • If you're requesting Advarra to write a draft ICF, you must upload a protocol document in the appropriate tab.
    • If you're requesting other services, you must upload at least one document that’s relevant to the submission (such as the item for which you're requesting review or the item for which you're requesting translation).
11. Click Save.
12. Click Submit.
13. 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.