Permissions: Users must have RBQM, Data Central, and View privileges assigned to a study to access RBQM and manage Alerts, Risk Signals, and Issues in RBQM.
Assigned unlicensed users can access Risk Signals and Issues, and respond to assigned records through the limited Signals and Issues view.

RBQM uses configured KRI and QTL thresholds to identify potential risks. When a threshold is exceeded, RBQM generates an Alert. Alerts can then be reviewed and, if needed, promoted to Risk Signals to document observations and root cause analysis. When a risk is confirmed, a Risk Signal can be promoted to an Issue for formal tracking and resolution.

The Risk Signals section in RBQM includes Overview and Monitoring pages. Use the Monitoring page to review and manage Alerts, Risk Signals, and Issues for the selected study.

The Risk Signals card on the Risk Management page opens the Risk Signals > Overview dashboard. From the RBQM left navigation, select Risk Signals > Monitoring to access the Monitoring page.

Risk Signals and Issues can also be created from dashboards and profile pages in RBQM.

Issues created in RBQM are added to the Global Issues listing and have the same features and functionality as issues within Data Central and Global Issues.

Tip: Alerts, Risk Signals, and Issues can be assigned to both licensed and unlicensed users, including Site Monitors, CRAs, and external partners, to support cross-functional collaboration.

Understand the RBQM Risk Workflow

RBQM supports a structured workflow for risk communication and investigation.

• Risk Alerts are system-generated records created when a configured KRI or QTL breaches a defined threshold. Risk Alerts help identify potential risks for review and can be closed, reopened, combined, snoozed, or promoted to a Risk Signal or Issue.
• Risk Signals are used to document early observations, supporting evidence, and root cause analysis before a problem is confirmed. Risk Signals can be edited, answered, closed, reopened, combined, or promoted to an Issue.
• Issues are used to track confirmed problems that require formal follow-up and resolution. Issues support assignment, status tracking, and resolution through the issue management workflow.

This workflow supports traceability, collaboration, and compliant risk communication across the study lifecycle.

Access the Risk Signals Monitoring Page

To access the Monitoring page:

1. Open RBQM for the study.
2. In the RBQM left navigation, select Risk Signals > Monitoring.

Note: The Risk Signals card on the Risk Management page opens the Risk Signals > Overview dashboard. Select Monitoring in the RBQM left navigation to review and manage records.

The Monitoring page centralizes Alerts, Risk Signals, and Issues for the selected study.

Use the Monitoring Page

Use Filters

The Monitoring page opens with filters applied to display Open and Answered records for the current user. Click the Filtered by button at the top of the page to open the Applied Filters popout, which displays the columns with applied filters. Click X next to a filter to clear it. Filters can also be cleared from the filtered column using standard Data Central functionality. Columns can be sorted, filtered, fixed, and moved.

Quick Filters

The Quick Filters at the top of the Monitoring page provide access to records by status or assignment.

• Not Assigned, Not Answered, Open, Closed, Reopened, My Deferred, and All Deferred display the number of matching records out of all records. Quick Filter counts do not change when column filters are applied.
• Click a Quick Filter to filter the listing. Click All to display all records.
• When the Details panel is open, the Quick Filters display in a drop-down. Select a Quick Filter from the drop-down to filter the listing.

Configure Fields

Use Field configuration to control which columns display in the Monitoring listing.

1. Click the hidden fields button at the top of the page. The button displays the number of currently hidden fields.
   
2. In the Field configuration popout, select or clear fields to show or hide them in the listing.
3. Use Search to locate a field.
4. Click Show all to display all available fields.
5. Drag fields using the drag handle to change the column order.
6. Click Apply Configuration to apply the changes, or click Cancel to close the popout without applying changes.

Navigate the Listing

Use the controls at the bottom of the Monitoring page to navigate the listing:

• Use the rows per page drop-down to select the number of records displayed per page.
• Use the page navigation controls to move between pages.
• Enter a page number to navigate directly to a specific page.
• Review the page and record totals to see the current position and total number of records.

Use the Toolbar

The toolbar provides the following actions:

• Search: Search column headers. Click the Search icon and enter text in the Search field. Columns matching the entered text display in the listing. Alternatively, scroll through the listing and select a column header. Selecting a column header navigates directly to that column.
• Action: Select a record in the listing and click the Action icon to open the available actions. Actions depend on user privileges, record status, and record type, such as Risk Alert, Risk Signal, or Issue.
• Export: Click the Export icon to export the Risk Signals listing with or without comments.

Use the Row Context Menu

Right-click a record in the listing to open the context menu. Available options depend on the selected record and include:

• Filter by value: Filters the listing using the value in the selected cell.
• Details: Opens the Details panel for the selected record.
• Action: Opens the available actions for the selected record. Actions depend on user privileges, record status, and record type.

View Record Details

Double-click a record, or right-click a record and select Details, to open the Details panel.

The panel displays information for the selected record, including status, RBQM Snapshot, level, risk information, assignment, due date, and other record-specific details.

• Expand Comments to review comments associated with the record.
• Expand Related Records to review associated records.
• Click the Action icon to view available actions for the record.
• Click X to close the panel.

Review Records by Type

Risk Alerts are generated automatically when configured KRI or QTL thresholds are breached during an RBQM Snapshot. Alert details are based on the KRI or QTL configuration. Alerts identify potential risks for review and can be promoted to a Risk Signal for further investigation or to an Issue to track a confirmed problem. Once promoted to a Risk Signal or Issue, the record can be assigned to a user, user group, or role.

1. Open Risk Signals > Monitoring.
2. Review the table columns and apply filters as needed.
3. Open a record to review additional details.

Take Action on Records

Available actions depend on the record type, status, and user privileges. Actions can be performed on individual records or multiple selected records of the same type. Actions are available from the Action icon in the listing toolbar or the Details panel, or from the row context menu.

Available Actions by Record Type

• Risk Alerts: Close, Reopen, Combine, Snooze, Promote to Risk Signal, or Promote to Issue.
• Risk Signals: Edit, Answer, Close, Reopen, Combine, Promote to Issue, or Send Deferred Notifications.
• Issues: Edit, Start Progress, Move to Pending, Answer, Close, Close as Irresolvable, Cancel, Reopen, or Send Deferred Notifications.

Perform an Action

1. Select one or more records in the listing. To perform an action on multiple records, select records of the same type.
2. Click the Action icon in the listing toolbar or Details panel, or right-click a selected row and select Action.
3. Select an available action. Available actions depend on the record type, status, and user privileges.
4. Enter or update fields as needed in the window that opens.
5. Click Save or Apply, as applicable.

Common Actions and Use Cases

• Create and categorize signals: Capture emerging concerns at the study, country, or site level.
• Answer and comment: Support structured communication and cross-functional collaboration.
• Edit and reassign: Update levels, ownership, priority, and due dates to maintain accountability.
• Close: Close Open or Answered Risk Alerts and Risk Signals, or Answered Issues, when no further action is needed.
• Snooze: Snooze Risk Alerts for later review.
• Reopen: Reopen closed records when additional investigation is needed.
• Combine: Consolidate related Risk Alerts or Risk Signals with the same root cause to reduce duplication.
• Promote: Promote a Risk Alert to a Risk Signal or Issue, or promote a Risk Signal to an Issue.
• Send Deferred Notifications: Send notifications that were deferred for Risk Signals or Issues.

Send Deferred Notifications

Risk Signals and Issues can be marked to defer notifications for later delivery. Use the My Deferred and All Deferred Quick Filters on the Monitoring page to locate records with deferred notifications.

1. Click My Deferred to display records with deferred notifications for the current user, or click All Deferred to display all records with deferred notifications.
2. Select a Risk Signal or Issue. To send deferred notifications for multiple records, select records of the same type.
3. Access Send Deferred Notifications using one of the following methods:
   • Click the Action icon in the listing toolbar and select Send Deferred Notifications.
   • Right-click a selected record, select Action, then select Send Deferred Notifications.
   • For a single record, open the Details panel, click the Action icon, then select Send Deferred Notifications.
4. A confirmation message displays indicating that notifications were sent for the selected record or records.

Note: Send Deferred Notifications applies to Risk Signals and Issues. The action is not available for Risk Alerts.

Promote a Risk Alert to a Risk Signal

After reviewing a Risk Alert, create a Risk Signal to document the observation, supporting evidence, and investigation outcome.

Risk Signals provide a structured method to document observations and investigation outcomes.

• Document observations with supporting evidence.
• Perform root cause analysis.
• Track open and resolved signals.
• Consolidate related observations.
• Trace signals to originating KRIs or QTLs.

1. Select a Risk Alert.
2. Open Promote to Risk Signal using one of the following methods:
   • Select the record, click the Action icon in the listing toolbar, then select Promote to Risk Signal.
   • Open the Details panel, click the Action icon, then select Promote to Risk Signal.
   • Right-click the record, select Action, then select Promote to Risk Signal.

The Promote to Risk Signal window opens.

• Details for the selected Risk Alert display at the top of the window. The fields vary based on the alert type and level. For a country-level KRI alert, the details include Level, Country, KRI Name, KRI Score, Score, CTQ, and RBQM Snapshot.
  

3. Update and enter fields as needed. Due By and Reason For Promotion are required.

• Level: Click Change Level. In the window, click the Level drop-down and select a level.
  • In the Change Level window, adjust the scope between subject, site, country, and study levels to reflect the impact of the underlying issue.
  • Depending on the selected level, update other fields as needed, then select Save.
    
• Category: Select a category from the drop-down.
• Risk Description: Enter a description.
• Priority: Review the priority. The default Issue Priority configured in Configuration > Issue Priority is selected automatically. Click the drop-down to select a different priority, if needed.
• Assign To: User is selected by default. Select Role or User Group if needed.
  • Assignment can be to a specific user, role, or user group.
• User / Role / User Group: Select the appropriate user, role, or user group.
  • The Assign To User drop-down includes both licensed and unlicensed users.
• Due By: Review the due date and time.
  • The due date is calculated using the Due in Days value configured for the selected Issue Priority.
  • Update the due date and time by entering a new value or using the calendar icon, if needed.
• Action: Not Required is selected by default. Select Required if needed.
• Action Description: Enter a description when additional action details are needed.
• Send notification email: Select to send the assignee an email.
• Risk Signal Text: Displays the configured Risk Alert text. This field cannot be modified.
• Reason For Promotion: Enter the reason for promoting the Risk Alert.

4. Click Save.

Close Risk Alerts or Risk Signals

Risk Alerts and Risk Signals in Open or Answered status can be closed.

1. Select one or more Risk Alerts or Risk Signals.

   • When selecting multiple records, all selected records must be the same type, either Risk Alerts or Risk Signals.

2. Select Close using one of the following methods:

   • Select the record, click the Action icon in the listing toolbar, then select Close.
   • Open the Details panel, click the Action icon, then select Close.
   • Right-click the record, select Action, then select Close.

The Close Risk Alert / Risk Signal window opens.

3. Enter a value in the Closing Action field.
4. Select Requires Follow-Up, if needed.
5. Click Save.

Combine Risk Alerts or Risk Signals

Risk Alerts can be combined with other Risk Alerts, and Risk Signals can be combined with other Risk Signals. Once records are combined, the change is irreversible.

1. Select two or more Risk Alerts or Risk Signals to combine.
   • All selected records must be the same type, either Risk Alerts or Risk Signals.

2. Select Combine using one of the following methods:

   • Click the Action icon in the listing toolbar and select Combine.
   • Right-click a selected record, select Action, then select Combine.

   The Select Parent Record window opens.
   

3. Select the parent record. The remaining records become child records.
4. Click Apply.

Manually Create a Risk Signal or Issue

Risk Signals and Issues can be manually created from supported Overview pages, profile pages, dashboards, charts, and listings.

1. Navigate to the location where the Risk Signal or Issue should be created.

2. Select Create Issue or Create a Risk Signal using an available method:

   • Right-click a cell on the Sites or Countries Overview page.
   • Right-click a cell on a Site or Country profile page.
   • Click the Create icon from a supported dashboard chart or listing.

   The Create Issue or Create Risk Signal window opens. Details for the selected record display at the top of the window and vary based on the selected level and source.

3. Enter or update the fields as needed.
4. Click Save.

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

Create Issue Window

1. Priority: Review the priority. The default Issue Priority configured in Configuration > Issue Priority is selected automatically. Click the drop-down to select a different priority, if needed.

2. Assign To: User is selected by default. Select Role or User Group if needed.

   • Assignment can be to a specific user, role, or user group.
3. User / Role / User Group: Select the appropriate user, role, or user group.
   • The Assign To User drop-down includes both licensed and unlicensed users.
4. Due By: Review the required due date and time.
   • The due date is calculated using the Due in Days value configured for the selected Issue Priority.
   • Update the date and time by entering a new value or using the calendar icon, if needed.
5. Issue Text: Enter the issue text.
6. Configure Send Notification to User / Role / User Group.
   • 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 the Issue Notification task is scheduled in Tasks.
   • Select Defer Notification to delay the notification. Deferred notifications can be sent later from the Monitoring page. For more information, see Send Deferred Notifications.
7. Select Receive Notifications For Changes to receive notifications when priority, assignment, or status changes.
   • Options include Select All, Priority, Reassignment, and Status.
8. Click Save. The new Issue is added to the Issues listing.

Create Risk Signal Window

Enter or update fields as needed. Risk Signal Text is required.

1. Category: Select a category from the drop-down.
2. Risk Description: Enter a description.
3. Priority: Review the priority. The default Issue Priority configured in Configuration > Issue Priority is selected automatically. Click the drop-down to select a different priority, if needed.
4. Assign To: User is selected by default. Select Role or User Group if needed.
   • Assignment can be to a specific user, role, or user group.
5. User / Role / User Group: Select the appropriate user, role, or user group.
   • The Assign To User drop-down includes both licensed and unlicensed users.
6. Due By: Review the required due date and time.
   • The due date is calculated using the Due in Days value configured for the selected Issue Priority.
   • Update the due date and time by entering a new value or using the calendar icon, if needed.
7. Action: Required is selected by default. Select Not Required if needed.
8. Action Description: Enter the action details.
9. Configure Send Notification to User / Role / User Group.
   • 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 the Risk Signal Notification task is scheduled in Tasks.
   • Select Defer Notification to delay the notification. Deferred notifications can be sent later from the Monitoring page. For more information, see Send Deferred Notifications.
10. Select Receive Notifications For Changes to receive notifications when priority, assignment, or status changes.
    • Options include Select All, Priority, Reassignment, and Status.
11. Risk Signal Text: Enter the risk signal text.
12. Click Save.

Edit Risk Signals or Issues

To edit a Risk Signal or Issue from the Risk Signals listing on the Monitoring page:

1. Select the record.
2. Select Edit using one of the following methods:
   • Select the record, click the Action icon in the listing toolbar, then select Edit.
   • Open the Details panel, click the Action icon, then select Edit. 
   • Right-click the record, select Action, then select Edit.
3. Update fields as needed.
4. Click Save.

To edit an Issue from the Issues listing in Data Central or Global Issues:

1. Select the row.
2. Open the Details panel.
3. Click the Edit icon.
4. Update fields as needed.
5. Click Save.

Tip: Issues can also be managed from Global Issues. Click the 9-dot icon in the master header, then select Issues from the Platform Menu under Data Review. For more information, see the Global Issues section.

Tip: To quickly access open Issues that are assigned to the logged-in user, open Issues from the Platform Menu.

Export the Risk Signals Listing

Exporting the Risk Signals listing to Excel supports offline review, reporting, and stakeholder discussions.

1. Filter the listing as needed.
2. Click the Export icon in the toolbar.
3. Select Export Risk Signals or Export Risk Signals with Comments.