The submission workspace displays comprehensive information about a submission. This page is where you can complete submission-related activities, download submission and approval documents, and contact the IRB about a submission.

Submission Header

The submission name, ID, status, and type are displayed on the header.

• A: The submission name. The name is system-generated based on information you enter in the submission forms.
• B: The submission’s current status.
• C: The submission’s system-generated unique CIRBI ID.
• D: The submission type.

Submission Status

The submission status is displayed in the upper-left corner of the submission workspace. Status colors indicate whether action is required from you, Advarra, or neither (in the case of an end state). Statuses are defined below:
 

Migrated

Click the Migrated button to navigate to the original submission record in the legacy CIRBI system.

In Process Submissions

Click the In Process Submissions button to navigate to the In Process Submissions page, where you can view a list of the submission's secondary or site-associated submissions that are currently in process in the legacy CIRBI system.

On the In Process Submissions page, submissions are organized by type into four sections:

• Protocol Modifications
• Protocol PREs
• Protocol CRs
  • Note that both continuing review and termination submissions are listed in this section.
• Site Submissions
  • Note that both site submissions associated with the protocol submission and secondary submissions associated with site submissions, such as their continuing review or termination reports, are listed in this section.

Sections are collapsed by default. To expand a section, click the plus (+) icon. To expand all sections, click the Expand All button. To collapse a section or all sections, repeat the action by clicking the (-) icon or Collapse All button.

In each section, legacy CIRBI submissions of that type are listed with ID, Name, and State columns. In the Site Submissions section, a Parent Site ID column is also displayed. To navigate to a listed submission record in the legacy CIRBI system, click the ID link.

To return to the protocol submission workspace, click the ID link in the page header. To navigate to your dashboard, click the Dashboard button.

Submission Form

Click the Submission Form button to view a submission’s forms.

If the submission's IRB review hasn’t yet been completed and you have permission to edit the submission, you can also edit forms in this view. To save any edits you make, click the Save button. To discard edits, click the Exit button and then click the Ignore Changes & Exit button.

The submission ID, date submitted, submission status, and date of the submission's most recent status update are displayed above the forms.

Show Form Changes

During the submission review process, you might have had to edit your initial submission form responses in response to IRB-requested clarifications. You can compare changes you or other submission contacts have made to submission form fields across submission versions by clicking the Show Form Changes button on a submission form page.

In this view, each change to a submission’s status is considered a submission version. For example, submitting the submission to the IRB moves the submission into Administrative Review status (version 1). When Advarra requests clarifications for the submission during initial IRB processing, the submission moves to Administrative Clarifications Required status. When you edit or correct your initial form responses and submit your clarification responses to the IRB, the submission moves back to the Administrative Review status (version 2). The Show Form Changes button allows you to view a comparison of form edits across these submission versions.

To identify which submission forms have fields that changed between submission statuses, refer to the left-hand submission form menu and look for forms that display a pen and paper icon indicator.

To view form changes across submission versions, complete the following steps:

1. Click the Show Form Changes button.
   

2. The Current Version and Choose Version to Compare fields are displayed. The Current Version field displays the current submission version and can’t be changed. To choose a submission version to which to compare the current version, click the status beneath the Choose Version to Compare field.

   

3. In the right slider that appears, select a previous submission status version and then click the Apply Version to Compare button. Note that the same status might be listed multiple times if the submission has traversed through the same status more than once. In this scenario, you can refer to the version date and time to identify which versions you want to compare. Previous versions are listed chronologically in descending order.

   

4. A form field comparison appears beneath fields on the current form that changed between the selected submission versions. The left-hand side of the comparison displays the version in which the change was made. The right-hand side displays how the value changed, who made the change, and when the change was made. If a field didn’t change between the selected versions, no comparison is displayed.

   

Submission Form Printer Version

Click the Submission Form Printer Version button to view submission forms in printer-friendly format. You can’t edit forms in this view.

For particularly long printer views of forms, a Back to Top button is displayed at the bottom right-hand corner of the page. You can click it to automatically go back to the top of the form page.

IRB Issued Documents

If IRB review of a submission has been completed and documents have been posted in CIRBI, the IRB Issued Documents button is displayed. You can click this button to navigate to the IRB Issued Documents page.

Documents listed on this page may include approval letters, informed consent forms, and recruitment materials. IRB-issued documents on this page are organized by type in sections that are collapsed by default. The total number of IRB-issued documents is indicated in parenthesis to the right of the Issued Documents header. The number of documents of each type is indicated in parenthesis to the right of the document type header.

To expand a document type section, click the plus (+) icon. To expand all sections, click the Expand All button. To collapse a section or all sections, repeat the action by clicking the (-) icon or Collapse All button.

To return to the submission workspace, click the ID link. To return to the dashboard, click the Dashboard button.

Download Documents

To download a single document, click the document name link. The document automatically downloads to your computer.

The document version is appended to the document name link, and the icon to the left-hand side of the document name link indicates the file type. Note that only .pdf and .docx files have specific file type icons; all other file types are indicated by a blank piece of paper icon.

To download multiple documents in a batch, complete the following steps:

1. Click the Download Documents button.
   

2. In the right slider that opens, check or uncheck the document types you want to view and download; all types are selected by default.

   

   You can also search for specific documents you want to include in the batch by entering a keyword in the Search field and then clicking the Apply button.

   

3. For multi-site submissions: To include associated site-level documents in the list of downloadable documents, select the Include Associated Site-level IRB Issued Documents checkbox. Otherwise, leave the checkbox unchecked.

   

4. Documents that match all criteria are listed in the table with Project ID, Investigator, Type, Name, Size, and Posted Date columns. To select the documents you want to include in the downloaded batch, click the checkbox to the left of the document. As you make selections, the Estimated Batch Size field is updated to reflect the file size of the batch you’ve compiled. You can also click the Select All checkbox to include all listed documents in the batch. If you don’t make any selections, all IRB-issued documents for the submission and all associated sites (if applicable) will be included in the batch.

   

5. To start downloading the batch, click the Generate Batch Download button.

   

   • If the download is successful, a success message is displayed and a link to a .zip file of the batch documents is emailed to you. Click the link in the email to download the .zip file. Each document in the .zip folder maintains its original naming convention as it appears in CIRBI.
   • If the download is unsuccessful, an error might have occurred due to the size of the batch you attempted to download. You can try again by selecting fewer documents per batch to optimize performance.

Document Integration

If you would like to have your CIRBI submission’s approved documents automatically integrated with other applications, such as an eTMF system, you can request to have an outbound document integration enabled in CIRBI. To get started, contact your Advarra Client Executive or Strategic Partner.

This integration is fully enabled and managed by Advarra. For successful setup, you will be required to provide information to an Advarra specialist about the destination system and the fields in the destination system to which your documents must be mapped.

When the integration is successfully enabled, IRB-issued documents are automatically sent to the destination system soon after the documents are approved and posted in CIRBI. The following documents are included in the integration:

• Documents issued for a protocol submission
• Documents issued for a protocol’s secondary submissions (such as continuing review and reportable event submissions)
• For multi-site protocol submissions: Documents issued for associated site submissions and those sites’ secondary submissions

Submission Overview

This tab displays important submission information and dates.

• Protocol Title: The title of the protocol.
  • Note for site submissions: Prior to a site submission being processed by Advarra, the protocol title as it has been entered in the submission forms by the submitting party is displayed. After submission processing has begun, the protocol title of the associated parent protocol submission as it appears in CIRBI is displayed.
• Protocol ID: The unique CIRBI ID of the associated protocol for the site. This is only displayed on site and secondary submissions.
• Protocol Status: For secondary submissions such as modifications, this field displays the status of the protocol submission.
• Expiration Date: The date on which which the submission’s IRB approval will expire. If continuing review is required for the submission, you must submit a continuing review report prior to this date. This field is only displayed on protocol submissions.
• Site Expiration Date: The date on which the site submission's IRB approval will expire. If continuing review is required for the submission, you must submit a continuing review report prior to this date. This field is only displayed on site submissions and their secondary submissions, such as site continuing review submissions, site modifications, and site prompt reportable events.
• Protocol Expiration Date: The date on which the parent protocol submission's IRB approval will expire. If continuing review is required for the submission, you must submit a continuing review report prior to this date. This field is only displayed on site submissions and on secondary submissions of all submission types, such as continuing review submissions, modifications, and prompt reportable events.
• Review Interval: The interval at which IRB continuing review is required for the submission. This is only displayed for protocol submissions.
• Submitted Date: The date you submitted the submission to Advarra.
• Approval Date: The most recent date the submission was approved by the IRB.
• Initial Approval of Protocol: The date the parent protocol submission was initially approved by the IRB. For protocol submissions, the Approval Date and Initial Approval of Protocol date might differ if the submission has already undergone at least one continuing review interval.
• Advarra Client Services Coordinator: The name, profile photo, and email address of the submission’s assigned Client Services Coordinator at Advarra. If the assigned coordinator is out of office or is planning to be in the future, the dates they're out of office and the name of the user assigned as their backup is displayed.
• Advarra Client Services Processor: The submission’s assigned Client Services Processor at Advarra. This is usually the same person as the coordinator, but might differ for administrative reasons. If the assigned processor is out of office or is planning to be in the future, the dates they're out of office and the name of the user assigned as their backup is displayed.

Submission History

The submission history section displays a history of actions taken on the submission. For each action, the name of the activity, the name of the author, and the date the action took place are displayed.

The last 50 actions are displayed by default. To load more actions, click the Load More button. Counts of displayed and total actions are displayed beneath the button.

You can filter the list by clicking the Filters button. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

You can click a link in the Activity column to view detailed information about the record. 

• Activity Form: Data entered in the activity’s forms.
• Documents: Documents that were attached to the activity, if applicable. To download a document, click the File Name link. The date the document was uploaded is displayed in the Date column.
• Property Changes: A change history of the activity.
• Notifications: Notifications that were triggered by the activity, if applicable. For each notification, the following information is displayed:
  • The title of the notification. You can click the Title link to view a copy of the notification.
  • The recipient.
  • The recipient’s email address.
  • The date the notification was sent to the recipient.

Site Information

The Site Information tab displays information about sites associated with the submission. The list is paginated and 50 records are displayed per page.

For each site, the following information is displayed. You can click a column header to sort the list on a particular column:

• ID: The unique CIRBI identifier of the site submission. You can click the ID link to navigate to the site’s workspace in CIRBI.
• Name: The principal investigator’s name.
• State: The current status of the site submission in CIRBI.
• Submitted: The date the site submission was submitted to Advarra.
• Submission Complete: The date IRB review of the site submission was completed.
• Site Expires: The expiration date of the site submission.
• Approval Documents Posted: The date IRB approval documents were posted in CIRBI.

You can filter the list by clicking the Filters button. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

You can export site information in .csv format by clicking the Export button. The file contains additional dates and information for each listed site. Additionally, the file respects any filters and sorting you’ve applied.

Modifications

The Modifications tab displays information about modifications that have been submitted for the submission. The list is paginated and 50 records are displayed per page.

For each modification, the following information is displayed. You can click a column header to sort the list on a particular column:

• ID: The unique CIRBI ID of the modification submission. You can click the ID link to navigate to the modification submission in CIRBI.
• Name: The name of the modification submission.
• UAP: Indicates if the modification is reporting an unanticipated problem.
• Description: The description of the modification as it was entered by the submitter.
• State: The current status of the modification submission in CIRBI.
• Date Submitted: The date the modification submission was submitted to Advarra.

You can filter the list by clicking the Filters button. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

Continuing Review/Terminations

The Continuing Review/Terminations tab displays information about continuing review or termination reports that were submitted for the submission.

For each continuing review or termination, the following information is displayed:

• ID: The submission’s unique CIRBI identifier of the continuing review or termination. You can click the ID link to navigate to the submission in CIRBI.
• Name: The name of the submission.
• Date Submitted: The date the continuing review or termination was submitted.
• State: The current status of the continuing review or termination submission in CIRBI.

Clarifications

The Clarifications tab displays clarifications about the submission that have been requested by Advarra. You can view and respond to clarifications in this tab. Refer to the Clarifications page for more information.

List of Suspensions

The List of Suspensions tab displays suspensions associated with the submission.

Within this tab, several sub-tabs are displayed to organize suspensions into the following categories:

• Protocol Level Modifications with Suspend Determination
• Site Level Modifications with Suspend Determination
• Protocol Level PREs with Suspend Determination
• Site Level PREs with Suspend Determination

Click a sub-tab to expand it. In each sub-tab, the following information is displayed:

• ID: The submission’s unique CIRBI identifier. You can click the ID link to navigate to the submission in CIRBI.
• Name: The name of the submission.
• Date Reviewed: The date the submission’s IRB review was completed.
• Determination: The IRB’s determination.
• Type of Suspension: The type of suspension as determined by the IRB.

You can click the View All button in any subtab to view a complete list of all suspensions in that category.

Attachments

The Attachments tab displays attachments, profiles, or records that you or other submitting parties attached to submission forms while creating the submission. Note that attachments listed in this tab are not approval documents or other Advarra-provided documents; documents that have been provided by Advarra are located in the IRB Issued Documents section of the workspace.

Within this tab, several sub-tabs are displayed to organize records into categories. You can click a sub-tab to expand it or click the Expand All button to expand all sub-tabs. To collapse a sub-tab, click it again or click the Collapse All button to collapse all sub-tabs.

A counter is displayed on the main Attachments tab to indicate the total number of attachments listed in the section. Additionally, counters on each sub-tab indicate the number of attachments in a sub-tab.

Note that not all sub-tabs are displayed for all submission types.

• Protocol Documents
• Sponsor Submitted Informed Consent Form Documents with Tracked Changes
  • Only displayed for multi-site protocol modification submissions
• Recruitment/Subject Facing Materials
• Sponsor Submitted Informed Consent Form(s)
• Translated Materials
• Drug/Biologics Profile(s)
• Active Comparator/Package Insert
• Device Profile(s)
• In-Vitro Diagnostic Device Profile(s)
• Mobile Application(s)
• Mobile Application Details
  • Only displayed for single- and multi-site protocol submissions
• Cosmetic Information
  • Only displayed for multi-site protocol submissions and advisory review submissions
• Cosmetic Ingredient List
  • Only displayed for multi-site protocol submissions and advisory review submissions
• Food/Dietary Supplement Ingredient List
  • Only displayed for single- and multi-site protocol submissions when Study Type = Food/Dietary Supplement [US Research]
• Other Documents
• Federal Grant
  • Only displayed for single- and multi-site protocol submissions and advisory review submissions
• CV of Principal Investigator
• Waiver of IRB Oversight
• Broad Consent Document(s)
• Informed Consent Documents
• Informed Consent Templates
  • Only displayed for generic materials submissions
• Product Information
• ICF for IRB Review
  • Only displayed for correction modification submissions created from single- or multi-site protocol submissions or site submissions
• Supplemental Materials
  • Only displayed for generic materials submissions
• Generic Materials Uploaded in Smart Form
  • Only displayed for generic materials submissions
• Purchase Order Document(s)
  • Only displayed for protocol submissions (all types), advisory review submissions, and generic materials submissions
• Institutional COI Management Plan Document(s)
  • Only displayed for single-site protocol submissions and site submissions
• Sub-Investigator CV
  • Only displayed for single-site protocol submissions and site submissions
• Regulatory Inspection Information
  • Only displayed for single-site protocol submissions and site submissions
• Revised Site-Specific Informed Consent Form Documents with Tracked Changes
• Audits
  • Only displayed for modification submissions or Audit Report reportable event submissions created from single-site protocol or site submissions
• Informed Consent Form(s)
• HDE Document(s)
  • Only displayed for continuing review and termination report submissions created from single- or multi-site Humanitarian Use Device (HUD) protocol submissions
• Patient Brochure
  • Only displayed for continuing review and termination report submissions created from single-site protocol or site submissions
• Additional Clinicians
  • Only displayed for Humanitarian Use Device (HUD) single-site protocol submissions and continuing review and termination report submissions created from single-site protocol or site submissions
• Translation Documents
  • Only displayed for modification submissions created from single- or multi-site protocol submissions or site submissions
• Change of PI CV
  • Only displayed for modification submissions created from single-site protocol submissions or site submissions
• Change of Sub-Investigator CV
  • Only displayed for modification submissions created from single-site protocol submissions or site submissions
• eConsent
• Product Version(s)
• Medical License
  • Only displayed for standard, expanded access, and Humanitarian Use Device (HUD) single-site protocol and site submissions
• National Provider Identifier
  • Only displayed for expanded access site submissions and Humanitarian Use Device (HUD) single-site protocol submissions
• FDA form 3926, FDA form 1571 and/or any related FDA documentation/communication noting FDA approval of the submission
  • Only displayed for expanded access multi-site protocol, single-site protocol, and site submissions

Attachment Information

Document Attachments

In most sub-tabs containing documents, the following information is displayed:

• File Name: The file name. You can click the File Name link to download the file to your computer.
• Date: The date the file was uploaded.

In the Recruitment/Subject Facing Materials sub-tab, the following information is displayed:

• Type of Material: The type of material; options include Recruitment or Subject-Facing.
• Document Name: The document name. You can click the Document Name link to download the file to your computer.
• Document Type: The type of document, such as Radio, Television, or Diary.
• Category: The document category; options include New Material, Revised, or Final Format.

Profile Attachments

In sub-tabs containing profile records such as the Drug/Biologics Profile(s), Device Profile(s), In-Vitro Diagnostic Device Profile(s), and Cosmetic Information sub-tabs, a Name column displays the name of the associated profile. You can click the Name link to view and edit the profile. Documents attached to the profile are listed beneath the profile’s Name link. The document version is appended to the document name link. You can click the document name link to download the file to your computer.

Regulatory Inspection Information/Audit Attachments

In the Regulatory Inspection Information and Audits sub-tabs, the following information is displayed for each listed record. Each record is expanded by default:

• Type: The type of audit. You can click the Type link to view the submission form on which the audit was reported.
• Date: The date the audit occurred.
• Audit Finding: The audit finding.

Note that all audits reported as part of the current submission as well as any other audits related to the parent submission are listed in this sub-tab. Documents associated with the audit record are listed beneath the record. The document version is appended to the document name link. You can click the document name link to download the file to your computer.

All SAEs Reported by Sites

The All SAEs Reported by Sites tab displays serious adverse event (SAE) reports that have been reported at the site level by sites associated with the submission. Within this tab, the following information is displayed:

• ID: The submission’s unique CIRBI identifier. You can click the ID link to navigate to the submission in CIRBI.
• Name: The name of the SAE submission.
• First Name: The principal investigator’s first name.
• Last Name: The principal investigator’s last name.
• Date Submitted: The date the SAE was submitted in CIRBI.
• Report Type: The report type of the SAE as was entered by the submitting user.
• Event Description: The description of the SAE as was entered by the submitting party.
• Subject Number: The subject number associated with the SAE.

You can filter the list by clicking the Filters button. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

You can export the list in .csv format by clicking the Export button. The exported file respects any filters you’ve applied.

Reportable Events

The Reportable Events tab displays reportable events that are relevant to the submission using the following logic:

• For protocol and site submissions, it displays all reportable events that have been reported at the level of the current submission. For multi-site protocols, reportable events reported at the site level aren’t displayed in this tab.
• For continuing review and termination report submissions, it displays all reportable events that have been reported at the level of the current submission's parent submission. For example, if the continuing review report submission was created for a single-site protocol submission, the tab lists all reportable events that have been reported at the level of the single-site protocol submission.

This tab is displayed when the current submission is in any of the following statuses:

• Approved
• Suspended
• Approved With No Continuing Review Required
• Non-Human Research Determination
• Exempt Confirmed
• Withdrawn
• Disapproved
• Terminated
• Expired

Within this tab, several sub-tabs are displayed to organize attachments into the following categories:

• IND Safety Reports
• Data Monitoring Committee (DMC)
• Audit Reports
• Unanticipated Problems (UAPs)
• Protocol Deviation/Violation List
• Serious Adverse Events
• Serious/Continuing Non-Compliance

A counter is displayed on each sub-tab to indicate how many reports of that type have been submitted.

The lists are paginated and 50 records are displayed per page.

Click a sub-tab to expand it. In each sub-tab, some or all of the following information is displayed depending on the event type. You can click a column header to sort the list on a particular column:

• ID: The submission’s unique CIRBI identifier. You can click the ID link to navigate to the submission in CIRBI.
• Name: The name of the submission.
• Date Submitted: The date the reportable event was submitted in CIRBI. If the current submission is a site submission and the event was originally reported at the protocol level, this column displays the date the event was reported at the protocol level.
• Report Type: The report type of the SAE as was entered by the submitting party.
• Event Description: The description of the SAE as was entered by the submitting party.
• State: The current submission status of the submission in CIRBI.

You can filter a particular list by clicking the Filters button in each sub-tab. Available filters vary by sub-tab. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

All Protocol Deviations/Violations Reported by Sites

The All Protocol Deviations/Violations Reported by Sites tab displays deviation or violation reports that have been reported at the site level by sites associated with the submission.

Within this tab, the following information is displayed. You can click a column header to sort the list on a particular column:

• ID: The submission’s unique CIRBI identifier. You can click the ID link to navigate to the submission in CIRBI.
• Name: The name of the submission.
• First Name: The principal investigator’s first name.
• Last Name: The principal investigator’s last name.
• Date Submitted: The date the deviation/violation was submitted in CIRBI.
• Description: The description of the deviation/violation as was entered by the submitting party.
• Subject Number: The subject number associated with the deviation/violation.

You can filter the list by clicking the Filters button. Enter filter criteria in the available fields and then click the Apply button. To reset the applied filters, click the Reset Filters button. To close the filter section, click the Filters button again.

You can export the list in .csv format by clicking the Export button. The exported file respects any filters you’ve applied.

All Sites

The All Sites tab displays information about site submissions affiliated with the current submission’s protocol and the continuing review or termination reports they’ve submitted. Within this tab, the following data is displayed:

• ID: The site submission’s unique CIRBI identifier. You can click the ID link to navigate to the site submission in CIRBI.
• Site Submissions: The principal investigator’s name.
• SSU State: The submission status of the site submission in CIRBI.
• Expiration: The expiration date of the site submission.
• Submitted: Indicates whether the site has submitted a continuing review report. If yes, a green checkmark is displayed.
• CR Submission State: The submission status of the site’s continuing review report in CIRBI. You can click the CR Submission State link to navigate to the site’s continuing review report in CIRBI. If the site hasn’t submitted a continuing review report, “N/A” is displayed.
• ICF: The total number of subjects who signed the informed consent forms, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.
• Follow-up: The total number of subjects in follow-up only, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.
• Active: The total number of subjects who are still active in the research study, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.
• Comp: The total number of subjects who have completed their participation, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.
• PreTerm: The total number of subjects who prematurely terminated from participation after meeting enrollment criteria, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.
• SF: The total number of subjects who screen failed, as indicated by the site in the Site Enrollment Questions form in the site’s continuing review report.