Single-Site Protocols

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

1. Click the Begin button on the right-hand side of the Single-Site Protocol description. The submission forms are displayed.
2. On the lead-in form, enter the full protocol title (required), protocol number, sponsor (required), and funding information (required) in the applicable fields. If you indicate that you have your own internal tracking number that’s different from the protocol number, an additional required field is displayed to allow you to enter the tracking number.
3. Click Save & Next.
4. On the following form, identify the submission’s principal investigator by clicking the Add Investigator button. In the right slider that appears, you can search for the PI by using the Name, Email, or Organization drop-down filter, entering a search term, and then clicking Apply. To select a PI, click the radio button by their name and then click the Close button.

   • If the PI has a CIRBI account but isn't associated with your organization, you can enter their full email address in the provided field.

     

   • If the PI doesn’t already have a CIRBI account, you won’t be able to submit the submission until they create one. They can create an account using the steps outlined on the Registration page.
5. If the PI you selected already uploaded their CV in CIRBI, it's automatically populated in the CV of Investigator field and you can skip to the next step. If they haven’t yet uploaded their CV, click the Add Document button. In the right slider that opens, select or drag and drop their CV from your computer and then click the Submit Document button.
6. In the Sub-Investigator section, indicate whether you want to submit a sub-investigator/co-investigator's information for IRB review. If you indicate that you want to, additional required fields are displayed.
7. In the Staff Member Access and Primary Contact sections, identify the submission’s team members and a primary point of contact from your organization. You must indicate the submission role, editing permissions, and contact preferences for each study staff member you identify. Refer to the Edit Contact and Notifications/Edit Site Contacts section in the Submission Actions topic for more information.
8. On the second half of the form, enter invoice recipient and purchase order information. You can optionally upload purchase order-related documentation by clicking the Add Document button.
9. Click Save & Next.
10. On the subsequent forms that are displayed, fill in the remaining fields for funding information, IRB review type, informed consent forms, protocol procedures, conflicts of interest, investigator experience, site/local context information, informed consent process, and document attachments as required. Click Save & Next to save information on one form and proceed to another.
11. 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 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.
    • To enter the PI's medical license number, click the Medical License Number tab and enter the number in the free text field.
12. Click Save and then click Submit.
13. 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.