To submit a site application submission to the IRB, complete the following steps:
- Click the Begin button on the right-hand side of the Site Submission description. The submission forms are displayed.
- Identify the submission’s principal investigator by clicking the Select 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.
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If the PI 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 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 in the Registration section.
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- If the PI you selected already uploaded their CV in CIRBI, skip to the next step. If they haven’t yet uploaded their CV, click the Add Document button, select their CV from your computer, and then click the Submit Document button.
- Enter the full protocol title and protocol number in the respective fields. These fields are required.
- Click Save & Next.
- Fill in the remaining forms for research locations, regulatory inspections, conflicts of interest, investigator experience, site/local context information, and informed consent process as required. Some information might already have been entered by the PI during previous CIRBI submissions; if so, the information is automatically populated in the forms, and you can update the information in the form if needed. Otherwise, you must manually enter it when prompted. Click Save & Next to save information on one form and proceed to another.
- On the final Document Attachment Summary form, you must upload any required supporting documents 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 or 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, Submit Document, 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.
- Click Save and then click Submit.
- 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.
Note the following information about site submissions:
- The principal investigator (PI) and any site staff who will need to submit information, receive notifications, or retrieve documentation from CIRBI throughout the life of the study must have a CIRBI account and must be added as a submission contact/team member or point of contact via the Edit Site Contacts activity on the submission workspace. Refer to the Submission Actions page for more information.
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Informed Consent Forms (ICF) Translation Guidance:
- Initial Submission and Review: Sites must indicate in their initial site submission if they need translated informed consent forms (ICFs) and for which required languages. After a site’s initial IRB approval documentation is posted in CIRBI, the site (or the sponsor/CRO on their behalf) must submit a Modification form from the site submission to formally request the site-specific ICF translations. The translation request is processed by Advarra through our third-party vendor. After the translation is finalized, Advarra will post the translated documents, applicable certificates of translation, and a corresponding acknowledgement notice in CIRBI.
- Requesting Translations after Initial Review: If translation isn’t needed at the start of the study, the site (or the sponsor/CRO on their behalf) can submit a Modification form to request the site-specific ICF translation at any time after initial submission.
- Subject Materials: When English-language subject materials are approved for use across all sites on a study, the sponsor/CRO can opt to proactively request the materials be translated by submitting a Modification form at the protocol submission level. For all-site translated materials, Advarra will proactively post the corresponding translated subject materials in the site submission workspace when a site requests a translated ICF of the particular language. Sites requiring translations of site-specific subject materials should submit a Modification form at the site submission level. This can be completed by the site or the sponsor/CRO on the site’s behalf.
- Studies approved by another IRB prior to Advarra integration might need to make variations to the translation processes outlined above.
- The IRB requires the PI’s CV, medical license number, and information about any audits (such as FDA/OHRP) that have occurred in the last 5 years, including relevant audit finding and response documentation.