Close Enrollment

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

link.png For more information, see “Review Comments”.