Modify Submission Request

This action allows the IRB Administrators to assign the protocol to a committee and schedule and to change the protocol submission review type.

The assign to committee and/or schedule action makes the protocol eligible to be reviewed by IRB committee members through a full board or expedited or exempt review. The committee/schedule selection serves as a precursor to make many other actions available.

In addition the “Modify Submission Request” action allows the IRB Administrator to change the review type. The investigator may set the review type during initial protocol submission.

The system will present pre-defined checklists for Expedited and Exempt reviews if the review type is Expedited or Exempt.

 

Screen shot 2014-05-12 at 10.57.24 AM.png

Figure 961 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request (Submitted Protocol, Full– Status:  Submitted to IRB)

 

Screen shot 2014-05-12 at 10.56.04 AM.png

 

 

Figure 962 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request (Submitted Protocol, Expedited – Status:  Submitted to IRB)

 

Screen shot 2014-05-12 at 10.56.41 AM.png

Figure 963 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Layout (Exempt Checklist Example)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 281 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Field Descriptions

Field                                

Description

Committee

Select the desired committee from the list of names 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.

Schedule Date

Select the date/location/time option from the list of scheduled committee meetings 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. The schedule date selection will display only the permissible current or future meeting date schedules to which the protocol can be assigned.

Submission Type

Select one of the following options from the list:

•      Initial Protocol Application for Approval

•      Continuing Review/Continuation without Amendment

•      Amendment

•      Response to Previous IRB Notification

•      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.

Submission Review Type

Select one of the following options from the list:  Full, Expedited, Exempt, Limited/Single Use, IRB Review not required, Response, or FYI.  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.

Billable

To indicate that the sponsor is billed for protocol review, click within the checkbox to select the item.  A check mark appears within the checkbox to indicate the item is selected.  Click within the checkbox again to clear the mark and deselect the item.

note.png  Only a person with an IRB Administrator role has the ability to edit the Billable checkbox selection after saving.

 

tip.png  This option may not appear based on your institution’s unique implementation of KC, as it is controlled by an implementation parameter to allow institutions who do not bill, or who track this information in other systems, can remove it from view.

Type Qualifier

Select one of the following from the list:  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.

Checklist (Type)

Differs depending on the action (for example, Exempt or Expedited).  Click the green arrow  symbol to view full text in a separate browser window.  Click within the checkbox to select the item.  A check mark appears within the checkbox to indicate the item is selected.  Click within the checkbox again to clear the mark and deselect the item for all applicable items.

Submit

Click the submit button to generate the action request.