Multi-Site Protocols

To submit a multi-site protocol submission to the IRB, complete the following steps:

1. Click the Begin button on the right-hand side of the submission type description. The submission forms are displayed.
2. Enter the protocol title, protocol number, sponsor, and funding information in the respective fields. If you indicate you have your own internal tracking number that’s different from the protocol number, an additional required field is displayed.
3. Click Save & Next.
4. 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.
5. 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.
6. Enter invoice recipient and purchase order information in the bottom half of the form, if required. You can optionally upload purchase order-related documentation by clicking the Add Document button.
7. Click Save & Next.
8. Fill in the remaining forms for IRB review type, informed consent forms, protocol procedures, protocol research populations, and site information, as applicable. Click Save & Next to save information on one form and proceed to the next.
9. On the final Document Upload Page form, you must 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, OK and Add Another, or Submit Document 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 OK or OK & Add Another button.
10. Click Save and then click Submit.
11. In the window that appears, click Submit Application. Your submission is created and submitted to the IRB for review.

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.