Close
The Close action allows an IRB administrator to close an IRB protocol. They can enter comments to explain the reason for closure. A closed protocol indicates that all activities pertaining to human subject research as indicated in the protocol is complete.
Table 351 Protocol Document, Protocol Actions Page, Request an Action Section, Close Action – Action Attributes
|
Action attributes |
Description |
|
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. |
Figure 1155 Protocol Document, Protocol Actions Page, Request An Action Section, Close Actions Sections Layout
Table 352 Protocol Document, Protocol Actions Page, Request An Action Section, Close Action - Field Descriptions
|
Field |
Description |
|
Close | |
|
Comments |
Enter the rationale behind the close action.
Click within the text box (or press the tab |
|
Action Date |
Select the date you want the close action to become
effective. Click the calendar |
|
Review Comments |
|
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.
