Request to Re-open Enrollment

This action allows the investigator to submit a request to reopen enrollment of participants into the study which has been previously closed to enrollment.  The request to reopen enrollment requires subsequent action by the IRB Administrator to reopen enrollment.

 

Table 351 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Request to Re-open Enrollment Action Attributes

  Action attributes

Description

Who can perform action

This action can be initiated by investigators.

Protocol state prior to action

Prior to the action being performed, the protocol must be in the following state:

The protocol status must be in Active - Closed to Enrollment

The submission status can be in any state.

Protocol state after action

After the action is performed:

The protocol status does not change.

The submission status changes to Pending

 

Figure 713 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Record Committee Decision  Action Layout

 

Table 352 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Re-open Enrollement Field Descriptions

Field

Description

Committee

Select the desired Committee name from the list.  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.

File Name

Click the Browse.. button.  In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button.  The File Name field now displays the directory, folder path and filename you selected.

Reason

Enter text that describes the rationale behind the action request.  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.

Attachment

Click the Browse button. In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button.  The File Name field now displays the directory, folder path and filename you selected.

Description

Enter text that describes the attachment. 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. 

Add

Click the add  button to add your attachment as a row in the table below, which will become a numbered line item. 

Click the submit button to generate the action request.