Submit for Review

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Submit for Review

The Submit for Review action allows the investigators to submit protocols, amendments, renewals and response to revision requests to the IACUC office. The system also allows for investigators to y select the review type for the protocol and the committee and schedule for the review of the protocol based on institutional configuration.

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 IACUC Administrators, access the IACUC Protocol Review Type maintenance table from the Maintenance menu. For any submission review type values such as (Full Committee Member Review, Designated Member Review etc.) that an institute does not want the investigator to select, set the Global Flag indicator to No Submission Review Type value with Global Flag indicator set to Yes will be visible to both investigators and IACUC Administrators. Submission Review Type values, which have the Global Flag indicator, set to No, will be visible only to IACUC Administrators.

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 IACUC_COMM_SELECTION_DURING_SUBMISSION accessible through the System Admin menu. Based on institutional policy and preference the system parameter can be set to one of the following three values 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 569 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Submit for Review – Action Attributes

Action attributes	Description
Who can perform action	Investigators can initiate this action.
Protocol state prior to action	Prior to the action being performed, the protocol must be in the following state: The protocol can be in one of the following states: “Pending/In Progress”, "Withdrawn”, Minor Revisions required", "Major Revisions Required", "Tabled", "Return to PI", "Administratively incomplete", "Administratively withdrawn" and "Disapproved”. The submission status can be in any state.
Protocol state after action	After the action is performed The protocol status changes to Submitted to IACUC. The submission status changes to Submitted to Committee if committee is selected or Pending if committee is not selected

Figure 1391 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Submit for Review Layout

Table 570 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, Response to Previous IACUC Notification, Request to Deactivate, Request to Lift Hold, FYI, Amendment, Renewal, Renewal with Amendment, Continuation/Continuing Review, Continuation/Continuing Review with Amendment, Request Suspension, Notify IACUC.

, 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: Modification/Amendments/revision/Significant New Findings, Annual Scheduled by IACUC, Contingent/Conditional Approval/Deferred Approval/Non-Approval, Eligibility Exceptions/Protocol Deviations, AE/UADE, Complaint, Deviation, IACUC Protocol-related COI report, Self-report for Noncompliance, Request for eligibility exception, Training certification, Unanticipated problems and Annual report.

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 committee member review, Designated Member Review, Administrative Review, FYI, Response and IACUC Review not required 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.

Configurable display of committee and schedule for selection by investigator during protocol submission

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.

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.