Who can perform action

IRB Administrators are allowed to perform 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 one of the following: "Active - Open to Enrollment", "Active - Closed to Enrollment", "Active - Data Analysis Only", "Exempt", "Suspended by Investigator", "Suspended by IRB" “Request to Close”

The submission status can be in any state.

Protocol state after action

After the action is performed

The protocol status changes to Closed by Investigator (if the request to close was initiated by the investigator) and Closed Administratively (if the request to close was not initiated by the investigator).

The submission status changes to Closed.

Close

Comments

Enter the rationale behind the close action. 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. 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.

Action Date

Select the date you want the close action to become effective. Click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.

Review Comments