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, converted into Risk Signals to document observations and root cause analysis. When a risk is confirmed, a Risk Signal can be converted into an Issue for formal tracking and resolution.

Users can access Risk Signals by clicking the Risk Signals card on the Risk Management page. Selecting the card opens Risk Signals in RBQM for the selected study.

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 list 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 Risk Signals in RBQM

There are several ways to access Risk Signals in RBQM:

• From the Risk Signals or RBQM card on the Risk Management home page.
• From the Risk Signals tab in RBQM.

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

The Risk Signals page opens filtered to display Open and Answered records for the user. Clear filters using standard Data Central functionality, i.e., clicking the Status row header or the Filters icon in the toolbar. Columns can be sorted, filtered, fixed, and moved.

The metric blocks at the top of the window display the number of Not Assigned, Not Answered, Open, Closed, and Reopened records. Click any of the metric blocks to filter the list based on the metric. To reset the list, click the metric block again.

The blue badge next to Risk Signals in the header indicates the number of filtered records displayed.

Use the Toolbar

Users can also right-click a row to open the context menu and access many of the same actions available from the toolbar or the Details view.

• Previous / Next Page: Navigate through the pages.
• Details: Select a record in the listing and click the Details icon to open the panel on the right.
• Action: Select a record in the listing, click the Action icon in the listing or Details panel to open the list of actions. Actions depend on the user privileges, status of the record, and type of record (i.e., Risk Alert, Risk Signal, or Issue).
• Search: Search column headers. Click the Search icon, type in the Search field, as text is entered, columns matching that text display in the list, or scroll through the list and select a column header. Selecting a column header navigates directly to the column header.
• Maximize / Restore: Click to maximize or restore the panel.
• Export: Click to export the Risk Signal listing with or without comments.
• Close: Click the X icon in the Details panel to close it.

Review Records by Type

Risk Alerts are generated automatically when configured KRI or QTL thresholds are breached during an RBQM run. 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.

2. Review the table columns and apply filters as needed.

   Tip: The listing is sorted alphabetically by Type, so Issues display first. Use the Type column filter to view Issues, Risk Alerts, or Risk Signals.

3. Select a record to review additional details.

Take Action on Records

Available actions depend on the record type, status, and user privileges. Users can take action from the listing, the Details view, or 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, or Promote to Issue.
• Issues: Start Progress, Move to Pending, Answer, Close, Close as Irresolvable, Cancel, or Reopen.

Perform an Action

1. Select one or more records in the listing, or open a record in the Details view.
2. Click the Action icon, or right-click a row to open the context menu.
3. Select an available action.
4. Enter or update fields as needed in any window that opens.
5. Click Save or Apply.

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 records that are in an Answered status and no longer relevant.
• Snooze: Snooze Risk Alerts for later review.
• Reopen: Reopen closed records when additional investigation is needed.
• Combine Signals: Consolidate related records 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.

Promote a Risk Alert to a Risk Signal

After reviewing an 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. Click the Action icon and select Promote to Risk Signal. The window opens.
   • Details, such as Level, QTL Name, Score, CTQ and Data Snapshot display in the top section of the window. The details depend on the selected alert and change when level parameters are updated.
     
3. Update and enter fields as needed. The only required field is Reason for Promotion.
   • Level: Click Change Level. In the window, click the Level drop-down and select a level.
     • In the Change Level window the scope can be adjusted 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: Click the drop-down to select a different priority.
   • Assign To: Role is selected by default, select User 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.
     • Names that display in the Assign To User list include both licensed and unlicensed users.
   • Due By: Review the date.
     • Optionally, update the date by entering a new value or using the calendar icon.
   • Action: Not Required is selected by default. Select Required if needed.
   • Send notification email: Select to send the assignee an email.
   • Risk Signal Text: This field cannot be modified, it is the configured Risk Alert text.
   • Reason For Promotion: Enter the reason for promoting the alert.
4. Click Save.

Promote a Risk Alert or Risk Signal to an Issue

Issues are created after a Risk Alert or Risk Signal has been investigated and confirmed. Issues represent validated risks that require tracking, assignment, and resolution.

1. From a Risk Alert or Risk Signal, select Promote to Issue. The window opens. The top portion of the window displays issue details.

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

   

2. Update and enter fields as needed.
   • Level: Click Change Level. In the window, click the Level drop-down and select a level.
     • Depending on the selected level, update other fields as needed, then select Save.
   • Priority: Click the drop-down to select a different priority.
   • 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.
     • Names that display in the Assign To User list include both licensed and unlicensed users.
   • Due By: Review the 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.
   • Send notification email: Select to send the assignee an email.
   • Issue Text: This field cannot be modified, it displays the text from the Risk Alert.
   • Reason For Promotion: Enter the reason for promoting to an issue. This reason displays in the record comments.
3. Click Save. The issue is added to the Issues listing in Data Central and Global Issues, and the Type is updated to Issue in the Risk Signals listing.

Close Risk Alerts or Risk Signals

Open and Answered Risk Alerts and Risk Signals can be closed.

1. Select one or more Risk Alerts.
2. Click the Action icon and select Close. The Close Risk Alert / Risk Signal window opens.
   
3. Enter a value in the Closing Action field.
4. Optionally, select Requires Follow-Up.
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 the records to combine.
2. Click the Action icon and select Combine. The Select Parent Record window opens.
   
3. Select the parent record. Non-selected records become child records.
4. Click Apply.

Manually Create a Risk Signal or Issue

Risk Signals and Issues can be created from the Sites or Countries Overview pages, dashboards, charts, profiles, and listings.

1. Right-click a cell on the Sites or Countries Overview pages, Sites or Countries profile pages, or click the Create icon in a chart on the Trial Level Risks dashboard.
2. Select Create Issue or Create a Risk Signal. The Create Issue / Create Risk Signal window opens displaying details in the top portion.
3. Enter or update fields in the Create window.
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: Click the drop-down to select a different priority.
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.
   • Names that display in the Assign To User list include both licensed and unlicensed users.
4. Due By: Review the 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.
5. Issue Text: Enter the issue text.
6. 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.
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

Update and enter fields as needed. The only required field is Risk Signal Text.

1. Category: Select a category from the drop-down.
2. Risk Description: Enter a description.
3. Priority: Click the drop-down to select a different priority.
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.
   • Names that display in the Assign To User list include both licensed and unlicensed users.
6. Due By: Review the date.
   • Optionally, update the date by entering a new value or using the calendar icon.
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.
   • 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. Risk Signal Text: Enter the risk signal text. This is a required field.
12. Click Save.

Edit Risk Signals or Issues

To access the Edit Risk Signal or Edit Issue window from the Risk Signals listing:

1. Select the row in the Risk Signals listing, or right-click the row, or open the Details view.
2. Click the Action icon and select Edit.
3. Update fields as needed.
4. Click Save.

To access the Edit Issue window from the Issues listing in Data Central or Global Issues:

1. Select the row.
2. Click the Details icon to open the Details view.
3. Click the Edit icon.
4. Update fields as needed.
5. Click Save.

Tip: Issues may also be managed from Global Issues. Click the 9-dot icon in the master header to access Issues from the Platform Menu under Data Review. For more details on how to manage Issues, see the Global Issues section.

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