Notify Committee

This action allows the IRB Administrator to list an expedited approval in a full committee meeting schedule. A typical scenario might be that the investigator submits a protocol for expedited review. Neither the investigator nor the IRB Administrator selects a schedule for the submission. In many institutions the IRB office does not want to put the expedited protocol on a schedule prior to approval. After the IRB Administrator performs expedited approval on the protocol submission, the Notify Committee action allows the IRB Administrator to include the expedited protocol in a schedule. Once the Notify Committee action is performed it is recorded within the History section of the protocol, where all protocol actions are maintained in chronological order.

 

Table 333 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Notify Committee – Action Attributes

  Action attributes

Description

Who can perform action

IRB Administrators can perform this action.

Protocol state prior to action

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

The Submission Review Type must be Expedited

The protocol status must be in Submitted to IRB

The submission status can be in any state.

Protocol state after action

After the action is performed

The protocol status does not change.

The submission status does not change

 

Figure 704 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Notify Committee Action Layout

 

Table 334 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Notify Committee Field Descriptions

Field

Description

Committee ID

This field displays the identifier of the IRB committee the protocol is assigned to. This is a read only field.

Committee Name

This field displays the name of the IRB committee the protocol is assigned to. This is a read only field.

Comment

Enter textual detail that will serve as the notification content.  Click within the text box to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.  Click the add note  icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document.  After saving, click the green arrow  symbol to view full text in a separate browser window.

Action Date

Specify the date you want this action to become effective.  By default, the field displays the current date.  To change it, click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.

Submit

Click the submit button to generate the action request.