Submission Requirements

In order to successfully submit your study for IRB review, you might need to upload some or all the following materials during the submission or review process:

• Protocol documents, including any diaries, questionnaires, and other associated documents
  • Note that submitting recruitment and study-related materials is optional at the time of initial submission of the study to the IRB.
• Federal funding grant documents, if applicable
• Informed consent form (ICF) documents in Microsoft Word (.docx or .doc) format
• Investigator’s brochures and/or package inserts for drug studies (can be uploaded in the Drug Profile  submission form)
• Product information for device studies (can be uploaded in the Device Profile submission form)

For site submissions, principal investigators or study coordinators at the site might need to upload some or all the following materials:

• Principal investigator’s CV
• FDA audit documentation
• Waiver of IRB oversight (if you have a local IRB)
• Additional ICF text or wording
  • Advarra recommends that you have this wording undergo sponsor/CRO approval prior to its submission to the IRB.
• Compensation amounts or compensation-related language, as applicable

Submission Forms

After you select a submission type, the applicable submission forms for the submission type are displayed. These forms are where you will enter most of the information Advarra requires to proceed with IRB review, so ensure that you enter detailed and accurate information. Required fields are indicated by an asterisk (*).

• A: The list of forms you must submit for the submission type you’ve chosen. As you respond to form questions, additional forms might be added to the list based on your responses.
• B: The submission’s unique CIRBI identifier that’s assigned to the submission when you create it. A submission identifier’s prefix is indicative of the submission type; for example, protocol submissions begin with “PRO” and site submissions begin with “SSU.”
• C: These buttons allow you to save, exit, and navigate between submission forms:
  • To save your changes and exit the submission form workflow, click Exit and then click Save My Submission & Continue Later. To exit the submission form workflow without saving your changes, click Exit and then click Exit again (if you haven't changed the form since the last time you saved) or click Ignore Changes & Exit (if you have changed the form since the last time you saved).
  • To save a form and remain on the same form, click Save.
  • To navigate between submission forms, you can either click the name of a form in the left-hand menu or click the Save & Next or Save & Previous (if you have edit permission for the submission) or Next & Previous (if you don't have edit permission for the submission) buttons. If you have edit permission, any changes you make to the current form are saved when you navigate to a different form.
  • To submit the submission, click Submit.

Form Statuses

The colored banner and dot on the form menu indicates a form’s status. An incomplete form has a blue or gray banner and dot. Blue means that the form you’re currently viewing hasn’t yet been saved, while gray means that a form you’re not currently viewing hasn’t yet been edited nor saved.

A completed form has a green banner and dot.

A form containing errors or missing information has an orange banner and dot.

Completing Form Fields

CIRBI submission forms contain several types of data entry fields ranging from free text to document attachments.

In some fields, you may need to click an Add [record] button in order to add a record to the field, such as a personnel member, document, or product. To complete these fields, click the Add [record] button and then enter or select data in the right slider that appears.

Uploading Documents

Add Document Button

When you click the Add Document button in a form field, you can either search your computer to select a file to upload or drag and drop a file into the upload form. There's no limit to how many files you can select or drag and drop into the upload form at one time. For each file you upload, you can optionally enter a custom document title.

When you've selected or dragged-and-dropped all files you want to upload, click the Submit Document button to start the upload process. While files are uploaded, a progress bar is displayed to indicate if the upload was successful or unsuccessful. If the upload is successful, the bar is green.

If it's unsuccessful, the bar is red. If it's red, you can click the retry icon to retry the upload process for that file.

Files can't exceed 256 MB. If you need to submit a file that's larger than 256 MB, an IRB representative might request you upload the file to a secure file transfer page instead of directly uploading the file into the CIRBI application.

Drag and Drop Document Into Field

You can also drag and drop a file directly onto a document upload field in forms or activities. If you use this method to upload files, you must save the form or submit the activity in order to save the documents, and you can only apply custom document titles to them using the Rename Document workflow described below.

Revising or Renaming Documents

When you've uploaded a document to a field, you can upload a revision or rename the document by clicking the Actions menu (...) to the right of the document and clicking the appropriate action. Note that both of these actions upversion the document by one count (for example, if a document is V1 before you rename it, the renamed document subsequently becomes V2).

Upload Revision

With this action, you can upload a document revision. In the window that opens, you can optionally enter a custom document name in the Document Title field and then select a document from your computer or drag-and-drop a document to upload as a revision. If multiple revisions have been uploaded, the previous versions are listed in this window in view-only format. To download a previous version to your computer, click the Uploaded File link.

Rename Document

With this action, you can rename the current document. In the window that opens, enter a new document name in the Document Title field and then click Rename Document.

Show Form Changes

Refer to the Show Form Changes topic on the Submission Workspace page.

Post-Creation

Upon successful submission, you will navigate to the submission workspace and the submission will transition to the Awaiting Assignment status. When the submission is received by Advarra, you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission. 

You can view a copy of the attestation to which you're required to agree in the Submitted for Review activity record in the submission's Submission History log.