Submit for Review

The Submit for Review action allows the investigators to submit protocols, amendments, renewals and response to revision requests to the IRB office. The system allows for investigators to optionally select the review type for the protocol and also the committee and schedule for the review of the protocol.

tip.png

Configure Submission Review Type: To control which submission review type values should be visible to only the investigator and which should be visible to both investigators and the IRB Administrators, access Protocol Review Type from the Maintenance menu. For submission review type values such as (Full, Expedited etc.) that should not be visible to the investigator, set the Global Flag indicator to No. Submission Review Type values with  Global Flag value set to Yes will be visible to both investigators and IRB Administrators.

tip.png

Configure Committee and Schedule selection: The system allows implementing institutions to control whether the investigators should be able to select the committee and schedule during protocol submission. This is enabled through the system parameter IRB_COMM_SELECTION_DURING_SUBMISSION accessible through the System Admin menu. The following options are available: M - Display committee and schedule and make their selection mandatory during protocol submission; O - Display committee an d schedule and make it optional to select committee and schedule during protocol submission.; D - Do not display or allow selection of committee and schedule during protocol submission.



Table 412 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Submit for Review – Action Attributes

  Action attributes

Description

Who can perform action

This action can be initiated by investigators.

Protocol state prior to action

Prior to the action being performed, the protocol must be in the following state:

 

The protocol status must be in one of the following states: Pending/In Progress, Withdrawn, Specific Minor Revisions, Substantial Revisions Required,  Deferred,  Response Required

The submission status can be in any state.

Protocol state after action

After the action is performed

The protocol status changes to Submitted to IRB.

The submission status changes to Submitted to Committee if committee is selected or Pending if committee is not selected

 

 

 

Figure 1190 Protocol Document, Protocol Actions Page, Request An Action Section, Available Actions – Submit for Review Layout

 

Table 413 Protocol Document, Protocol Actions Page, Request An Action Section, Available Actions – Submit for Review Field Descriptions

Field

Description

Submit for Review

Submission Type

Required.  Select one of the following options as appropriate:  Initial Protocol Application for Approval, Continuing Review/Continuation without Amendment, Amendment, Response to Previous IRB Notification, or Continuing Review/Continuation with Amendment.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Type Qualifier

Select one of the following options as appropriate:  Request for Eligibility Exception, Training Certification, Unanticipated Problems, DSMB Report, Annual Report, Annual Scheduled by IRB, Contingent/Conditional Approval/Deferred Approval/Non-Approval, Eligibility Exceptions/Protocol Deviations, AE/UADE, Compliant, Deviation, Protocol-related COI Report, or Self report for Noncompliance.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Committee

Select the desired option from the list of committee names.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Submission Review Type

Select one of the following:  Full, Expedited, Exempt, Limited/Single Use, IRB Review not required, Response, or FYI as appropriate.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

note.png  If expedited or exempt, then checklist items appear and are required, which is the same behavior as in the Modify Submission Request action.

Schedule Date

Select the desired date from the list that is automatically populated with available meeting dates based on your selection in the Committee field.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Click this button to command the system to submit the review request you selected and notify recipients of the action request, which will appear in their respective action lists.