Modify Submission Request

This action allows the IRB Administrators to change the protocol submission review type. The review type may be set by the investigator during initial protocol submission. This action becomes available only after the protocol has been submitted to the IRB. The system will present pre-defined checklists for Expedited and Exempt reviews if the review types changed to Expedited or Exempt.

 

 

Figure 1173 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request (Submitted Protocol, Expedited – Status:  Submitted to IRB)

 

Figure 1174 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Layout (Exempt Checklist Example)

 

Table 382 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Field Descriptions

Field                                

Description

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.