Permissions: Users with the ODR Configure or ODR Read Write privilege can create, assign, and take actions on issues. 
Users with the ODR Read or ODR Analytics privilege can review and answer issues assigned to them.
Unlicensed users can access only issues assigned to them and can review and respond to those issues.

Issues provides a collaboration tool within elluminate to communicate and resolve issues. Issues are created and tracked within elluminate and are not pushed to external systems, except when an email notification is sent to the assigned user.

Within the Operational Data Repository, issues can be created from a record in a panel grid, such as Investigational Products, Programs, or Studies, or while editing a record.

Create an Issue

Create an Issue from a Grid

1. Select a panel in the left navigation, such as Investigational Products, Programs, or Studies.
2. Select the row.

3. Open the Create Issue window using one of the following methods:

   • Click the Create Issue icon in the toolbar.
   • Right-click the row and select Create Issue.

Create an Issue While Editing a Record

1. Select a panel in the left navigation, such as Investigational Products, Programs, or Studies.
2. Select the row in the grid and click the Edit icon. The Edit window opens.
3. Click the Create Issue icon in the toolbar. The Create Issue window opens. 

Enter Issue Details

The Create Issue window separates editable issue details from read-only record information. The Information section displays record details, which vary based on where the issue is created.

1. Enter the Issue Text. The character counter displays the number of characters entered and the 4,000-character limit.
2. Click the Priority drop-down and select a priority. The priority color indicator and configured due period display with the selected priority.
3. In Assign To, select User or User Group. 
   • Names available when assigning to a user include both licensed and unlicensed users. Unlicensed users must be added to elluminate by users with the appropriate privileges.
4. Select the User or User Group to assign the issue to.
5. Review the Due Date.
   • By default, the date reflects the configured Issue Priority. 
   • Optionally, update the date by entering a new value or using the calendar icon.
6. Configure Send Notification to User / User Group, depending on the assignment type. 
   • None is selected by default.
   • When assigning to an unlicensed elluminate user, select a notification option.
   • Select Immediately to send the notification immediately.
   • Select In Batch if a task to send Issue Notifications is scheduled.
   • Select Defer Notification to delay the notification and send it later from Global Issues.
7. Under Receive Notifications For Changes, select the changes for which notifications should be received. Options include Select All, Priority, Reassignment, and Status.
8. Click Save.

The issue is created and available in the Related Issues window in ODR, and the Issues listing in Global Issues.

Tip: This window can be moved by dragging it elsewhere on the screen to view the window behind it. 

View Related Issues

1. In the Open Issues column, click the hyperlinked number for a record. 
   
   
   The Related Issues window opens.
2. By default, the Related Issues window displays only open issues, indicated by the highlighted Filters icon. To view all related issues, clear the filter.
   

Take Action on an Issue

Issues can be actioned directly from the Related Issues window using the Action icon. To view or edit an issue in Global Issues, click Issue Details. Available actions depend on the issue status and user privileges.

1. Select a row in the Related Issues window.
2. Click the Action icon and select an option:
   • Start Progress (if available)
   • Move Issue To Pending
   • Answer Issue
   • Close Issue
   • Close as Irresolvable
   • Cancel Issue
   • Reopen Issue (if available)
3. Complete the fields in the window that opens for the selected action, as applicable. For example, enter a response when answering an issue or a reason when canceling or reopening an issue.
4. Click Yes to complete the action or No to cancel.
5. Click the Close icon (X) to close the Related Issues window.

Tip: Issues cannot be edited from the Related Issues window. To edit an issue, click Issue Details to open the issue in Global Issues.

Note: The Start Progress action may be available depending on URL configuration. When available, an open issue can be moved to Start Progress and then to Answered.