The Close Enrollment action allows an IRB administrator to indicate that no new people will be enrolled for the human subjects research as indicated in the IRB protocol. The protocol remains active. The IRB administrator action is typically preceded by a researcher request to close enrollment for the protocol.
Table 303 Protocol Document, Protocol Actions Page, Request an Action Section, Close Enrollment 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 Active - Open to Enrollment The submission status can be in any state.
|
Protocol state after action |
After the action is performed
The protocol status changes to Active - Closed to Enrollment The submission status changes to Closed for Enrollment |
Figure 685 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Close Enrollment Layout
Table 304 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Close Enrollment Field Descriptions
Field |
Description |
Close Enrollment | |
Comments |
Enter textual comments pertaining to the rationale behind the close enrollment 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. After saved, click the green arrow symbol to view full text in a separate browser window. |
Action Date |
Select the date you want the close enrollment 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 |
For more information, see “Review Comments”. |