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 submission review type must be Response

The protocol status can be in any state

The submission status can be in any state

Protocol state after action

After the action is performed

The protocol status changes to Active - Open to Enrollment

The submission status changes to Approved

Response Approval

Approval Date

Specify the date you want the approval 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.

Expiration Date

Enter the future date when the approval will expire.  Click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date. 

Comments

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.  After saved, 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.

Enter Risk Level

Risk Level

Select one of the following options:

•      No greater than minimal risk.

•      Greater than minimal risk but potential for direct benefit for participant

•      Moderate Risk

•      Research involving greater than minimal risk, with no potential for benefit to participant, but likely to yield generalizable knowledge about the participant’s condition

•      High Risk

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.

  The available Risk Levels are modified via the Risk Level maintenance document.

Date Assigned

By default, this 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.

Date Inactivated

When the status is inactive, the date it became inactive is displayed.

Status

Display-only (for example, active).  The current status of the risk level.

Comments

To enter textual information to describe the selection of the risk level, 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.  After saved, click the green arrow  symbol to view full text in a separate browser window.

Actions

Click the add  button to add your selection to as a row in the table below, which will become a numbered line item.  Click the delete button to remove a previously-added line item row from the table.

Review Comments