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 status must be in one of the following statuses Active - Open to Enrollment, Active - Closed to Enrollment, Active - Data Analysis Only, Exempt, Suspended by Investigator, Suspended by IRB, Withdrawn, Suspended by DSMB, Expired, Disapproved, Terminated by IRB, Suspended by IRB or Suspended by DSMB

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 changes to Submitted to IRB or Pending

Submission 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.

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.

File Name

Click the Browse.. button.  In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button.  The File Name field now displays the directory, folder path and filename you selected.

Committee

Select the desired Committee name from the list.  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.

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 saved, click the green arrow  symbol to view full text in a separate browser window.

Attachment

Click the Browse button. In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button.  The File Name field now displays the directory, folder path and filename you selected.

Description

Enter text that describes the attachment. Click within the text box (or press the tab  key from a previous field) 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. 

Add

Click the add  button to add your attachment as a row in the table below, which will become a numbered line item. 

Submit

Click the submit button to generate the action request.