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 is used as a collaboration tool within elluminate to communicate and resolve issues. Issues are created and tracked within elluminate and are not pushed to any external systems except for optionally sending an email notification to the user the issue has been assigned to.

Within the Operational Data Repository (formerly CTMS Insights), issues can be created on a record within a panel grid (listing), such as Investigational Products, Programs, Studies, etc., or from the record edit window.

Create an Issue

From a Grid (Listing)

1. Select a panel in the left navigation, such as Investigational Products, Programs, or Studies.
2. Select the row in the grid where the issue will be created.
3. Click the Create Issue icon in the toolbar. The Create Issue window opens.

From a Record Edit Window

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 in the Create Issue Window

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

Issue details display at the top of the window and vary based on where the issue was created.

1. Click the Priority drop-down and select a priority.
2. In Assign To, select User or User Group. 
   • Names that display in the Assign To User drop-down include both licensed and unlicensed users. Unlicensed users must be added to elluminate by those with the appropriate privileges.
3. Click the User / User Group drop-down and select the appropriate user or user group.
4. Review the Due By date.
   • By default, the date reflects the configured Issue Priority. 
   • Optionally, update the date by entering a new value or using the calendar icon.
5. Enter the Issue Text.
6. Configure Send Notification to User / User Group. 
   • By default, None is selected.
   • 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 the Issues module.
7. Select Receive Notifications For Changes to receive notifications when priority, assignment, or status changes.
   1. 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 within the Issues module.

View Issues

Related Issues raised on an Operational Data Repository record can be viewed from within Operational Data Repository. There are multiple ways to access the Related Issues window.

View Issues from a Panel Grid (Listing)

From the Open Issues column of a panel grid, click the hyperlinked number. 


The Related Issues window opens.

By default, a filter is applied to display only open issues, indicated by the highlighted Filters icon. To view all related issues, clear the filter.

Action an Issue

Issues can be actioned directly from the Related Issues window using the Actions icon or the Issue Details button. Selecting Issue Details opens the Issues module in a separate tab and displays the issue details to the right of the Issues listing. Available actions depend on the issue status and user privileges.

1. Select a row in the Related Issues window.
2. Click the appropriate action button:
   • Issue Details: Opens the Global Issues listing in a separate tab.
   • Start Progress (if available)
   • Answer Issue
   • Close Issue
   • Reopen Issue (if available)
   • Cancel Issue
3. Click the Close icon (X) to close the window.

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

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.

Tip: Issues created in the Operational Data Repository can also be managed from the Issues module.