Issues is a collaboration tool within Data Central (including RBQM and eIQ Review) and Analytics for users to communicate and resolve issues for data available in these modules, including non-eCRF data, as well as issues related to subjects or EDC queries.

Issues are created and tracked within elluminate and are not pushed to any external systems, except that an email notification can optionally be sent to the user assigned to the issue.

Licensed elluminate users can create, assign, and take actions on issues, regardless of their reviewer role in Data Central. Unlicensed users only have access to their assigned issues, which they can review and respond to.

Issues created in Data Central (including RBQM and eIQ Review) and Analytics are included in the Issues panel within Data Central, as well as the global Issues module. 

Note: For details on how to create and manage RBQM-related issues, refer to the RBQM section.

Create Issues

Issues can be created from most records and listings within Data Central, including graphical patient profiles.

Important: Users with the Blinded Data View privilege see a warning message when creating record-, field-, or domain-level issues. The message identifies fields that contain blinded data. To prevent accidental unblinding, do not include blinded data in the Issue content. 

Tip: Easily create an issue and apply it to multiple records when creating an issue from a Domain or Exception Listing. For example, when there are questions about how several records were coded, a single issue can be entered once and applied to multiple records, rather than entering the same issue text for each one. This approach saves time when addressing common issues.

1. Identify where the issue is being created from (click the drop-down arrow to expand a section):
   • The Subjects Listing
     1. Select a record.
     2. Click the Create icon in the panel toolbar, or right-click a record and select Create, then select Create Issue.
        

   • A Domain or Exception Listing:

     Create A Single Issue

     1. Select a record.
     2. Click the Create icon in the panel toolbar, or right-click a record and select Create.
     3. Select Create Domain Issue or Create Record Issue.
        

     Create a Single Issue on a Field

     1. Right-click a cell.
     2. Select Create Field Issue.

     Apply Issue to Multiple Records

     1. Select the checkboxes to the left of each record where the issue will be added.
     2. Click the Create icon in the panel toolbar, or right-click a record and select Create.

     3. Select Create Domain Issue or Create Record Issue.
        

        Note: If multiple records are selected in an Exception Listing and each record has a different QueryText value, the Issue Text field is disabled and a message indicates that multiple values exist. When the issues are created, each issue uses the text from the corresponding selected record.

   • The Graphic Patient Profile

     Issue related to the Whole Profile

     1. Click the Create Issue icon in the panel toolbar.

     Issue related to a Specific Section of the Profile

     1. Click the Create Issue icon located to the right of the section.

     

   • The Details View
     1. Click the Create icon in the panel toolbar, then select Create Issue or Create Domain Issue.
        

2. The Create Issue window opens.
   

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

   Issue details are displayed in the top section of the window. Depending on where the issue was created, the details may include Type, Subject, Data Store, Site, Domain, Field, and Value. This section also displays any configured related fields and their corresponding values.

3. Click the Priority drop-down and select a priority.
4. In Assign To, select User, Role, or User Group.
   • Assignment can be to a specific user, role, or user group. 
5. Click the User / Role / User Group drop-down and select the appropriate user, role, or user group.
   • The Assign To User drop-down includes licensed users with access to the record and unlicensed users.
6. Review the Due By date.
   • By default, the date reflects the configured default Issue Priority. 
   • Optionally, update the date by entering a new value or using the calendar icon.
7. Review or update the Visit ID field, if available. 
8. Enter the Issue Text.
9. Configure Send Notification to User / Role / 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.
10. Select Receive Notifications For Changes to receive notifications when priority, assignment, or status changes.
    • Options include Select All, Priority, Reassignment, and Status.
11. Click Save. The new issue is added to the Issues listing.

Note: The email sent for a single issue includes additional source details based on the record where the issue was created.

Note: For a Domain or Exception Listing, when multiple issues are created at the same time, a single email goes to each appropriate user. The email includes a list of issues with a link to the user's open issues. The email does not list the details of the issue (subject, etc.) as there could be more than one subject in the batch. 

Note: Issues related to a study include the study name in the subject line of the issue notification email.

Access the Issues Panel

The Issues panel is accessed from the left navigation. The panel can be docked to the sheet, allowing the user to see issues along with other panels docked to the sheet. To work with Issues in full screen, maximize the panel.

The Issues panel supports User Domain Settings through the Issues Settings icon, allowing users to hide System Fields and Domain Variable columns to focus on relevant information. To see more details, see the 'Sort, Fix, Adjust, and Hide Columns in Data Central' article.

Tip: To view issues for records in domains marked as critical, scroll to the right and check the Criticality column.

Tip: Use the Search icon in the panel toolbar to locate a column by name or label. As text is entered, matching column names and labels display. Select a column name to navigate directly to that column. 

Filter Issues Panel Results

Filters are available for columns in the Issues panel. Columns that are filtered have a filter icon next to the column header. 

Issue substatuses are available in the Status column and can be filtered. These include Open – Reopened, Open – Pending, Closed – Snoozed (for KRI / QTL issues), and Closed – Irresolvable.

In the Status column, when a status includes a substatus, an icon displays next to the primary status. Hover over the icon to view the substatus.

Filter and sort issues by the assigned user, role, or group within the Assigned To column.

Tip: To find issues that require action, filter the listing by Status = Open and Assigned To = your user ID.

To find issues that were opened by the user and then answered, filter the listing by Opened By = your user ID and Status = Answered, review the response, and then close the issue.

If an issue is created by an Orchestrator rule, the Opened By column displays the name of the rule. This column can be filtered by the Orchestrator rule name.

Note: For more details on using filters, refer to the Use Filters in Data Central article in the Data Central section.

Open Record Details View

From the Issues panel or the Related Issues section of a Record Details panel, there are multiple ways to open the issue details view:

• Select a record and click the Details icon in the panel toolbar.
• Right-click a record and select Details.
• Double-click a record.

The panel toolbar displays a set of icons that allow taking action on the issue, docking the panel, maximizing or restoring it, and closing the panel. 

Use the scrollbar on the right to view more of the panel. The top portion displays Issue Details, any configured related fields and their values, followed by Record Details (if configured), Comments, Related Queries (if available), and Related Issues, which can be expanded to view existing entries or add new ones.

Tip: URLs can be configured to include Record Details for Issues. Issues created for a record include an expandable Record Details section located above the Comments section. This section is also available to unlicensed users. Click Record Details to expand and view the details.

Tip: From the Details view of an issue or query, expand the Related Issues section at the bottom of the panel to view all related issues. If an issue record has associated issues, the issue count badge does not display until Related Issues is expanded. Issues can be actioned from the Related Issues section using the toolbar above the section.

View the Source of the Issue

There are two ways to open the record, listing, or graphical patient profile where the issue was created:

• From the Issues Listing, click a link in the Type column for a record.
  
• From the Details view, click the link in the Type field.
  

The source opens in a new panel on the sheet which can be docked. Types include:

• Domain: Opens the domain listing, or the graphical patient profile.
• Query: Opens the query record.
• Record: Opens the record within a listing.
• Subject: Opens the subject detail record or the graphical patient profile.
• Study: Opens the RBQM dashboard where the issue was created. 
• Site: Opens the RBQM dashboard where the issue was created.
• Country: Opens the RBQM Countries dashboard where the issue was created.

Action Issues

Issues can be managed one record at a time by working in the Details view or actioned in groups from the Issues panel. Available actions depend on the Reviewer Role and the status of the issue. Issues are open until they are answered or canceled. After an open issue is answered, the status is updated to Answered. Issues with a status of Answered can be closed.  

Available Actions

• Previous / Next Record: Click the directional arrow to move to the previous or next record.
• Start Progress: Click to set an open issue to In Progress. (This action / status is only available when configured for the URL). 
• Move Issue to Pending: Click to move an issue to pending and enter a reason. This is a substatus of an open issue.
• Answer Issue: Click to Answer an open or in progress issue.
• Close Issue: Click to Close an answered issue, and optionally enter Closure Text to document final resolution details.
• Close as Irresolvable: Click to close an issue as irresolvable and enter a reason. This is a substatus of a closed issue.
• Snooze Issue: This is only available for RBQM-related issues.
• Cancel Issue: Click to Cancel an open or closed issue. Add an optional reason for canceling, then click Yes to confirm, or No to stop the action.
• Reopen Issue: Click to Reopen a closed issue.
  • The Reopen Issue window opens.
  • Make updates to Priority, Assign To, User / Role, Reason For Reopening, and Send Notification Email (checkbox).
• Edit Issue: All Data Central users can click to edit the priority, assignment, user/role/user group, or email notification on open or answered issues. The creator of the issue or a user with the Issue Administration privilege can also edit the Due By date, and the Issue Text.
• Maximize / Restore: Click to view full screen / return to view in sheet.
• Record Details (if configured for the URL): In the Record Details section, click the arrow to expand and view domain record details. This section is also available to unlicensed users.

• View or Add Comments: In the Comments section, click the expand arrow to see existing comments and add new comments.

  Note: Property details of a reopened issue are added to the Comments section by the system.

Action a Single Issue

1. Open the Details view for an issue.
2. The individual issue opens in a separate panel.
3. Use the panel toolbar icons to perform the appropriate actions for that individual issue. Depending on the selected action, enter any required reason or optional Closure Text if prompted.
4. Optionally, scroll down to the Record Details section (if available) and expand to see domain record details.
5. Optionally, scroll down to the Comments section and expand to see existing or add new comments.

6. Optionally, click the Edit icon in the panel toolbar, and the Edit Issue window opens. 

   Tip: This window can be moved by dragging it elsewhere on the screen, allowing dialog behind the window to be seen.

7. Make updates to Priority, Assign To, User / Role / User Group, or Send Notification Email (checkbox). The creator of the issue or a user with the Issue Administration privilege can also update the Due By date and the Issue Text.
8. Click Save. 

Note: To reopen a closed issue, the action must be performed in Details View.

Action Multiple Issues

1. In the Issues panel, select the checkboxes next to each record to be actioned.
2. Click the Action icon.

3. From the drop-down, select the appropriate action. Depending on the selected action, enter any required reason or optional Closure Text if prompted.
   

   Note: Actions that are grayed out indicate they are not available. Sometimes a field within a record must be highlighted first for an action to become active. In the screenshot, the selected issues have an open status, therefore the actions available are Start Progress, Move Issue to Pending, Answer Issue, and Cancel Issue. 

   Tip: To work through answered issues, set the filter to Status = Answered.