Permissions: Licensed elluminate users can create, assign, and take actions on issues, regardless of reviewer role in Data Central. Unlicensed users can access only issues assigned to them and can review and respond to those issues.

Issues is a collaboration tool within Data Central (including RBQM and eIQ Review) and Analytics that lets users communicate and resolve issues related to data, subjects, or EDC queries, including non-eCRF data.

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

Issues created in Data Central (including RBQM and eIQ Review) and Analytics display in the Data Central Issues panel and in Global Issues.

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. Select where to create the issue (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 Subject 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 for each record to add the issue to.
     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 Graphical Patient Profile

     Issue Related to the Entire 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 Record Details Panel
     1. Click the Create icon in the panel toolbar, then select Create Issue or Create Domain Issue.
        

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. The Configured Related Field(s) section displays configured related fields and their values, when applicable.

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

1. Enter the Issue Text.
   • The character counter displays the number of characters entered and the character limit.
2. Review or update the Visit ID field, if available.
3. Click the Priority drop-down and select a priority.
   • The drop-down displays a color indicator and the associated due timeframe next to each priority option.
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 Date.
   • By default, the date reflects the configured Issue Priority.
   • Optionally, update the date by entering a new value or using the calendar icon.
7. 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 Global Issues.
8. Under Receive Notifications For Changes, select the changes for which notifications should be received. Options include Select All, Priority, Reassignment, and Status.
9. 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.

View Field-Level Issue and Query Indicators in Record Details

Fields with associated Issues or Queries display a colored indicator in the Record Details panel opened from a listing. Indicator colors reflect the highest-priority status for the field:

• Red: The field has at least one Issue or Query in Open or In Progress status.
• Green: The field has no Open or In Progress Issues or Queries and at least one Answered Issue or Query.

• Black: All Issues or Queries for the field are Closed.

  

Tip: Hover over an indicator to display a tooltip summarizing field-level Issues or Queries, grouped by status.

Click an indicator to expand the Related Issues or Related Queries section and filter the table to display only the Issues or Queries for the selected field. Clicking an Issue or Query in that section highlights the corresponding field in the Record Details panel and scrolls it into view, if needed.

Access Related Issues and Queries from Record Details

Expand the Related Issues or Related Queries section at the bottom of the Record Details panel to view all related issues or queries. Issues and queries can be actioned from this section using the toolbar above the section.

View 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, 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 and Sort 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 = the user's ID.

To find issues that were opened by the user and then answered, filter the listing by Opened By = the user's 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 Issue Details

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 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.

View the Issue Source

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.

View Issue and Query Counts from Data Listings

Issue and Query counts displayed in Data Listings are interactive.

1. In a Data Listing, click an Issue or Query count for a record. The record expands to display the associated Issues or Queries.
2. Review the expanded details:
   • Open and In Progress Issues: Issue text, Issue ID, Priority, Field (for field-level Issues), Assigned To, Due Date, and Progressed By or Pended By, where applicable.
   • Open Queries: Query text, Query ID, Field, Notification Group, and Opened Date.
   • Answered and Closed tabs: Issue or query text, response, and the responding or closing user and date.
3. Click an Issue ID or Query ID to open the associated Issue or Query details directly.
4. Click the same count again, or press Esc, to close the expanded view. Clicking a different count opens that record's Issues or Queries immediately, replacing the current expanded view.

Note: If no Answered Issues or Queries exist but Closed ones do, the 0 in the Answered column remains clickable and opens the Closed tab. If no Answered or Closed Issues or Queries exist, the 0 is not clickable.

Tip: This quick view helps confirm whether review activity already exists for a record before creating a new Issue or Query, reducing duplicates.

Take Action on Issues

Issues can be actioned individually from the Details view or in groups from the Issues panel. Available actions depend on the Reviewer Role and issue status. Issues remain open until answered or canceled. After an open issue is answered, the status changes to Answered. An answered issue can then 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 is 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. Optionally, enter a reason for canceling.
• Reopen Issue: Click to reopen a closed issue. See Reopen a Closed Issue for details.
• 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 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.

Take Action on a Single Issue

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

5. 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 to view the window behind it.

6. Make updates to Visit ID, Priority, Assign To, User / Role / User Group, or Send Notification to User / Role / User Group. The creator of the issue or a user with the Issue Administration privilege can also update the Due Date and the Issue Text.
   • The Priority drop-down displays a color indicator and the associated due timeframe next to each priority option.
7. Click Save.

Reopen a Closed Issue

Reopening a closed issue must be performed from the Details view.

1. Open the Details view for a closed issue.
2. Click Reopen Issue in the panel toolbar. The Reopen Issue window opens.
3. Review the Issue Text. This field displays the original issue text and cannot be edited. The character counter displays the number of characters and the character limit.
4. Enter the Reason for Reopening. The character counter displays the number of characters entered and the character limit.
5. Review or update the Visit ID field, if available.
6. Review or update the Priority.
   • The drop-down displays a color indicator and the associated due timeframe next to each priority option.
7. Review or update Assign To and the User / Role / User Group.
8. Review the Due Date.
9. Configure Send Notification to User / Role / User Group.
10. Under Receive Notifications For Changes, select the changes for which notifications should be received. Options include Select All, Priority, Reassignment, and Status.
    • These notification settings apply to the reopened issue independently and do not carry over from the original issue.
11. Click Save.

Take Action on 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.