Modify Submission Request

This action allows an IRB Administrator 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 type is changed to Expedited or Exempt from another selection.

 

Figure 702 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request (Submitted Protocol, Expedited – Status:  Submitted to IRB)

 

Figure 703 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Layout (Exempt Checklist Example)

 

Table 332 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request Field Descriptions

Field                                

Description

Submission Type

One of the following options will populate automatically based on your previous selection:

 

•      Initial Protocol Application

•      Renewal with Amendment/Renewal without Amendment

•      Amendment

•      FYI

Submission Review Type

One of the following options will populate automatically based on your previous selection:  

 

•      Full

•      Expedited

•      Exempt

•      IRB Review not required

•      Response

 

To change, use the drop-down menu.  Click the down arrow to display the list, and then click on an item to select.

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.

 

Type Qualifier

NOTE: This feature is only used for submissions with Submission Review Type of “IRB Review not required.”

 

Select one of the following options from the drop-down menu:

•      IU Accepts Approval from another IRB

•      NCI

•      Non-Human Subjects

•      Student Project

•      WIRB

 

Use the drop-down menu by clicking the down arrow to display the list, and then click on an item to select.

*Checklist (Exempt or Expedited)

Differs depending on the Submission Review Type selected. Click within the checkbox to select the appropriate Category 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 button to generate the action request.