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

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. Click on a panel in the left navigation, e.g., Investigational Products, Programs, Studies, etc.
2. Highlight the record (row) in the grid (listing) where you wish to create the issue.
3. Click the Create Issue icon in the toolbar. The Create Issue window opens.

From a Record Edit Window

1. Click on a panel in the left navigation, e.g., Investigational Products, Programs, Studies, etc.
2. Highlight the record (row) in the grid (listing) and click the Edit icon. The Edit window opens.
3. Click the Create Issue icon in the toolbar. The Create Issue window opens. 

Enter the 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 are displayed at the top of the window and will vary based on where the issue was created.

1. Click the Priority drop-down arrow and select Priority.
2. Click User or User Group in Assign To.
   

   Note: 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 arrow and select the appropriate User or User Group.
4. By default, the Due By date based on Issue Priority configuration. Optionally, update the date by entering over the date displayed, or using the calendar icon.
5. Enter the Issue Text.
6. Click in the Send Notification to the User/User Group checkbox if appropriate. If the issue is assigned to an unlicensed elluminate user, be sure to check the box.
   
   1. Select either Send in batch or Send immediately. If Send in batch is selected, be sure a task is scheduled to send Issue Notifications.
7. Click in the Receive notifications for these changes checkbox if you (as creator of the issue) would like to receive notification when there are changes to priority, assignment, and status. By default, all three boxes are checked. Uncheck any boxes if you do not want to receive notification.
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)

1. From the Open Issues column of a panel grid (listing), click the hyperlinked number (this is the number of open issues). 
   
   
   The Related Issues window opens.
   
   The Related Issues window has a default filter applied to display only open issues; this is indicated by the highlighted Filters icon. To see all related issues, clear the filter.
   

Action an Issue

Users can action issues directly from the Related Issues window by clicking the Actions icon, or by clicking the Issue Details button which opens Global Issues in a separate tab, displaying the details record at the right of the Issues listing. Available actions depend on the status of the issue and your privileges. 

1. Highlight a row.
2. Click the appropriate action button: 
   • Issue Details (To open the Global Issues listing in a separate tab.)
   • Start Progress (if available)
   • Answer Issue
   • Close Issue
   • Reopen Issue (if available)
   • Cancel Issue
     

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

3. Click the Close icon (the x) to close the window.

Note: The action of 'Start Progress' may be available depending on the configuration of the URL. If available, users can action an Open issue to Start Progress, and then to Answered.

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