Permissions:  Users must have RBQM, Data Central, and View privileges to review and monitor data in RBQM.
Users must have RBQM, Data Central, and Study Configure privileges to configure RBQM.

Risk-Based Quality Management (RBQM) supports monitoring and analysis of Key Risk Indicators (KRIs) at the site and country level, along with management of Critical to Quality factors (CTQs) and Quality Tolerance Limits (QTLs) within Data Central.

RBQM dashboards display preconfigured metrics that identify potential risks in study conduct and provide visibility into how risks impact sites, countries, and overall study performance.

RBQM includes an integrated Alerts framework with issue management functionality. Alerts identify threshold breaches and support escalation into Risk Signals and RBQM Issues for tracking, root cause analysis, and resolution.

Benefits of RBQM

• Provides a centralized view of study, site, and country risk levels.
• Enables monitoring of KRIs, CTQs, and QTLs in a single workspace.
• Supports consistent risk identification and follow-up actions.
• Allows configuration of risk thresholds, indicators, and actions at global and study levels.

Access RBQM

RBQM can be accessed from multiple entry points.

From the Platform Menu

1. Click the 9-dot icon.
2. Select Risk-Based Quality Management under Risk Management.

From the Data Central Studies Page

• Click the RBQM Direct Link tile on a study card to open the Sites Overview dashboard.
• Click the study name, then select RBQM from the Data Central left navigation.

From Risk Management

Click the Risk-Based Quality Management card to open the Overview > Sites dashboard, or click the Risk Signals card to open the Risk Signals > Overview dashboard.

RBQM Navigation

RBQM uses a dedicated left navigation panel to access dashboards and profiles.

The left navigation includes the following sections:

• Overview
  • Sites
  • Countries
• Trial Level Risks
• KRIs
  • Sites
  • Countries
• Study Report
• Risk Signals
  • Overview
  • Monitoring
• Profiles
  • Sites
  • Countries

Use the left navigation to open the corresponding dashboard or profile.

Additional navigation options include:

• Click the Toggle Side Navigation icon to collapse or expand the navigation panel.
• Hover over icons to view tooltips when the navigation panel is collapsed.
• Click X to close the RBQM navigation panel and return to the Data Central navigation.
• Use the RACT link at the bottom of the navigation panel to open the current study in RACT. 
• Use the Risk Management link to open the Risk Management page.

Dashboard Functionality

General Dashboard Interactions

• Hover over data points to view details in a tooltip.
• Drag within charts to zoom.
• Use Zoom Out or Show All Data to reset the view.
• Use scrollbars to view additional data.

Listings 

RBQM listings follow standard Data Central behavior:

• Columns support sorting, filtering, and resizing.
• The first four columns remain fixed during horizontal scrolling.
• Blue badges display filtered row counts.
• Risk badges indicate risk distribution:
  • Green: Low risk
  • Yellow: Medium risk
  • Red: High risk
  • Gray: No data

• KRIs with no data are excluded from score calculations.

Risk Indicators and Issue Links

• Hover over a Risk Level gauge to view the risk level value.
• Warning icons identify KRIs driving elevated risk levels.
• Click a hyperlinked Issue count to open a filtered RBQM Issues listing as a floating panel.
• Right-click a hyperlinked Issue count and select:
  • View Issues to open the RBQM Issues listing in a floating panel
  • Open in New Sheet to open the RBQM Issues listing in a new sheet.

Create RBQM Issues and Risk Signals

RBQM Issues and Risk Signals can be created from several RBQM dashboards.

• Sites Overview, Countries Overview, and Profiles dashboards: Right-click a row and select Create Issue or Create a Risk Signal.
• Study Report dashboard: In the Sites or Countries listing, select a row, click the Create icon, and select Create Issue or Create a Risk Signal.
• Trial Level Risks dashboard: Click the Create icon in the toolbar for a QTL and select Create Issue or Create a Risk Signal.
• Individual QTL dashboards: In the Tolerance chart or Scores listing, click the Create icon and select Create Issue or Create a Risk Signal.

Note: For details on creating and managing RBQM Issues and Risk Signals, see the Manage Risks, Risk Signals, and Issues on the RBQM Monitoring Page article.

Map Interactions

Maps provide geographic visualization of site and country risk.

• Hover over a country to view a tooltip with the country name and score.
• Hover over a site marker to view a tooltip with the site name and score.

• Use the available icons to:

  • Show or hide sites.
  • Show or hide the world view.
  • Select a continent from the drop-down.
• Click a country or site marker to open a card displaying:
  • Score.
  • Hyperlinked KRIs.
  • Link to view additional details.
• Pin up to three site or country cards to compare KRIs.
• Use the mouse wheel to zoom in and out.

RBQM Overview Dashboards

The RBQM Overview includes two dashboards, Sites Overview and Countries Overview, which display site-level and country-level risk data, KRIs, and summary metrics from RBQM Snapshots.

Sites Overview

Countries Overview

Dashboard Content

Both dashboards:

• Display subject counts, scores, and KRI results for configured metrics.
• Use status icons, trend indicators, and warning icons to highlight emerging risks.
• Display missing values when data are unavailable for a metric.
• Provide a Legend that defines dashboard icons.

RBQM Snapshots

RBQM dashboards support timestamped RBQM Snapshots to review historical results.

Use the RBQM Snapshot drop-down to select an RBQM Snapshot.

Selecting an RBQM Snapshot updates the dashboards to display RBQM results from that point in time. Original scores remain unchanged even if underlying data or configurations change.

Snapshots support:

• Traceability of risk conditions
• Audit readiness
• Review of prior data states and actions

KRI and Trial Level Risk Details

Both dashboards include a details panel for KRI and Trial Level Risk information.

• Click the Details icon in a KRI header to open the KRI information that is not tied to a specific site or country.
• Click a KRI cell to open details for the selected site or country.

The panel includes two tabs:

• KRI Details: Displays the KRI description, configured risk levels, median KRI score, average KRI score, and recommendation, when configured.
• Trial Level Risks: Displays the Trial Level Risks associated with the selected KRI. Each Trial Level Risk displays its current score, risk status, trend, and a link to open the corresponding QTL dashboard.

Dashboard Actions

• Click a Site ID in Sites Overview or a Country in Countries Overview to open the corresponding profile.
• Right-click a row and select Create Issue or Create Risk Signal.
• In the Trial Level Risks panel, click the Create icon next to a Trial Level Risk and select Create Issue or Create Risk Signal.

Trial Level Risks Dashboard

The Trial Level Risks dashboard displays the QTL Overview by default. This view presents Quality Tolerance Limits (QTLs) configured for the study.

Select the CTQ View toggle to display Critical to Quality factors (CTQs). QTLs can be assigned to CTQs, and both provide study-level risk information. CTQs and QTLs are configured in Data Central Configuration.

The dashboard updates automatically after each scheduled RBQM Snapshot.

QTL Overview

The QTL Overview:

• Displays all configured QTLs.
• Opens the individual QTL dashboard when a QTL name is selected.
• Updates the threshold line when a QTL uses a dynamic threshold.
• Provides the Create icon for creating an Issue or Risk Signal.

CTQ View

The CTQ View displays configured CTQs and their associated QTLs.

• If no CTQs are configured, the CTQ View toggle is unavailable.
• Click the arrow next to a CTQ to expand or collapse its associated QTL charts.
• Each CTQ displays QTL counts by status:
  • In Control
  • Approaching Limit
  • Tolerance Exceeded

Individual QTL Dashboards

Individual QTL dashboards display tolerance limits and current and historical scores.

• The QTL name displays at the top of the dashboard.
• Use the drop-down next to the QTL name to switch between QTLs.

Tolerance Chart

• Scores display on the y-axis.
• RBQM Snapshot dates display on the x-axis.
• If the QTL uses a dynamic threshold, the threshold line updates accordingly.

If supporting data is configured:

1. Select Supporting Data.
2. Select an option from the drop-down.

The corresponding domain listing opens as a floating panel.

Shaded areas indicate the following risk levels:

• In Control
• Approaching Limit
• Tolerance Exceeded

Scores Listing

The Scores listing displays results by RBQM Snapshot date.

Columns include:

• Risk Level gauge
• RBQM Snapshot date
• Early Action Limit
• Tolerance Limit
• Score
• Status
• Trend Pattern

Toolbar actions:

• Select Export to download the data as an Excel file.
• Use the Previous and Next icons to navigate results (20 rows per page).
• Click the Create icon, then select Create Issue or Create Risk Signal.

KRIs Dashboards

Key Risk Indicators (KRIs) measure study performance at the site and country level. KRIs are configured in Data Central Configuration and update automatically after each RBQM Snapshot.

Examples of KRIs include:

• Study Conduct: Accrual Rate, Screening Success, Protocol Deviations, Drop-Outs
• Safety: Number of Adverse Events, Number of SAEs
• Treatment Compliance: Dose Reduction, Dose Delays
• Data Quality: Overdue Forms, Query Rate

KRIs Overview for Sites and Countries

The KRI Overview dashboards display aggregated KRI performance and issue metrics. By default, the dashboard displays Sites. Select Countries in the left navigation to switch views.

Score Distribution Chart

The Score Distribution box and whisker chart displays KRI score distribution. 

• KRIs display on the x-axis.
• Click a KRI box to open its individual dashboard.
• Hover over items in the Legend to highlight corresponding markers.
• Select Zoom Out to display all outliers.
• Select Zoom to Fit to reset the view.
• Select an outlier to open the Site or Country KRI card.

KRIs Listing

The KRIs listing includes:

• Risk Level gauge
• Number of open RBQM Issues
• Number of actioned RBQM Issues
• KRI Name
• Category
• Current Score
• Critical indicator
• Sites Threshold Count

Click a KRI name to open its individual dashboard.

Issues Per KRIs Chart

The bar chart displays the number of RBQM Issues per KRI, grouped by status.

• Colors represent Issue status (for example, open, answered, closed).
• Hover over a bar segment to view details.
• Select a segment to open the RBQM Issues listing filtered by that status.

Individual KRI Dashboards

Individual KRI dashboards display based on the configured scoring method. Supported scoring methods include no specific scoring, Z Score, and Clinical Statistical Monitoring (CSM).

• When no specific scoring or Z Score is configured, the dashboard displays:
  • Site or Country Risk Over Time
  • Sites or Countries by Risk Level
  • Scores Summary per Run
• When CSM scoring is configured, the dashboard displays:
  • Measurement Distribution by Site or Country
  • Site Comparison
  • Scores Summary for the most recent Run

By default, dashboards display data by Sites. Select Countries in the left navigation to switch views.

• The KRI name displays at the top of the dashboard.
• Use the drop-down next to the KRI name to switch between KRIs.
• A warning icon indicates the KRI is marked as critical.

No Specific or Z Score Configuration

Site / Country Risk Over Time Chart

• Scores display on the y-axis.
• RBQM Snapshot dates display on the x-axis.
• Each site or country displays as a separate line.
• Select a site or country in the legend to filter the chart and listing.
• Use the Show / Hide Legend icon to toggle the legend.
• Use the Show All Sites icon to return to view all sites.
• Click and drag to zoom into a selected range.
• Click Show all data to reset the chart.
• Select a site, then click the Create icon and select Create Issue or Create Risk Signal.

If supporting data is configured:

1. Click Supporting Data.
2. Select an option from the drop-down.

The domain listing opens as a floating panel on the dashboard.

Sites / Countries by Risk Level Chart

This pie chart displays the number of sites or countries by risk level.

• Select a section to open a popout list of sites or countries.
• The list includes:
  • Risk Level gauge
  • Site ID or Country code
  • Name (hyperlink)
  • Score
• Click the Name link to open the Site or Country dashboard.

Scores Summary per Run Listing

This listing displays:

• Risk Level gauge
• Site ID or ISO Code
• Site or Country Name
• RBQM Snapshot date
• Score

Additional actions:

• Click the Export icon to download data:
  • Export Latest
  • Export Full History
• Use the Previous and Next icons to navigate (20 rows per page).

CSM Scoring Configuration

When a KRI uses CSM scoring, the dashboard displays measurement distributions, site comparison, and scores for the most recent RBQM Snapshot.

Countries do not support CSM or Z Score methods.

Measurement Distribution by Site Chart

• Measurements display on the y-axis.
• Site numbers display on the x-axis.
• Each site displays as a box and whisker.
• Use the Show / Hide Legend icon to toggle the legend.
• Click and drag to zoom into a selected range.
• Click Show all outliers to reset the chart.
• Select a site in the legend to display that site in the chart.
• Use the Show All Sites icon to return to all sites.
• Select a site, then click the Create icon and select Create Issue or Create Risk Signal.

Site Comparison Chart

This pie chart compares sites using similarity groupings.

• Colors distinguish between similar and different sites.
• Select a section to open a popout list of sites.

The list includes:

• Risk Level gauge
• Site ID
• Name (hyperlink)
• Score

Click the Name link to open the site dashboard.

Scores Summary for Most Recent Run Listing

This listing displays:

• Risk Level gauge
• Site ID
• Site Name
• RBQM Snapshot date
• Score

Additional actions:

• Click the Export icon to download data:
  • Export Latest
  • Export Full History
• Use the Previous and Next icons to navigate (20 rows per page).

Study Report Dashboard

The Study Report dashboard provides consolidated risk information for the study, including CTQ, QTL, site, country, and KRI summaries. Access the Study Report from the left navigation.

QTL Overview

The QTL Overview displays by default.

• Color-coded gauges represent each QTL:
  • Green: In Control
  • Yellow: Approaching Limit
  • Red: Tolerance Exceeded
• A triangular marker indicates the current status.
• Status pills display:
  • Current state (In Control, Approaching Limit, Tolerance Exceeded)
  • Trend (Increasing, Decreasing, Steady)
• Click a QTL name to open the corresponding dashboard in Trial Level Risks.

CTQ Overview

Select the CTQ View toggle to display CTQs.

• Color-coded gauges represent each CTQ:
  • Green: In Control
  • Yellow: Approaching Limit
  • Red: Threshold Exceeded
• Click a CTQ name to open the corresponding view in Trial Level Risks, displaying the selected CTQ and associated QTLs.

Sites Listing

The Sites listing displays sites by risk level, from high to low.

Columns include:

• Risk Level gauge
• Hyperlinked Issue counts
• Site Name
• Site ID
• Subjects
• KRIs Over Threshold

Click a site row to open the site card.

The site card displays:

• Site Score
• Hyperlinked KRIs
• Link to View Site Details

KRIs Listing

The KRIs listing displays study-level KRIs.

Columns include:

• Risk Level gauge
• Hyperlinked Issue counts
• KRI Name
• Category
• Current Score
• Sites Threshold Count badges for associated sites (low, medium, high)

Click a KRI name to open its dashboard.

Countries Listing

The Countries listing displays participating countries.

Columns include:

• Risk Level gauge
• Country Name
• Country Code
• Score
• Sites Threshold Count badges for associated sites

Click a country row to open the country card.

The country card displays:

• Country Score
• Hyperlinked KRIs
• Link to View Country Details

Risk Summary Report

• Click the Report icon to open the Risk Summary Report in a separate window.
• Click Print to export the report as a PDF.

The report includes:

• Report Details
• CTQ Summary
• QTL Summary
• Site Summary
• Country Summary
• KRI Summary

Risk Signals Overview Dashboard

The Risk Signals Overview dashboard provides a summary of Alerts, Risk Signals, and RBQM Issues across the study. Use the dashboard to monitor signal activity, identify response trends, and navigate to filtered records.

Dashboard Summary

The summary cards display:

• Signals Overview: Displays the number of Risk Signals with and without actions.
• Open Risk Signals with No Response: Displays the number of open Alerts, Risk Signals, and RBQM Issues grouped by response age.
• Open Signal Types: Displays the number of open RBQM Issues, Risk Signals, and Alerts.

Dashboard Charts

The dashboard includes:

• Signals by Level: Displays the number of open and closed records by study, country, site, and subject level, when available.
• Average Signal Response Rate: Displays the average response time in days for Alerts, Risk Signals, and RBQM Issues across RBQM Snapshots.
• Dynamic filters: Use the available All Categories, All Types, and All Levels drop-downs to filter chart data. After selections are applied, each drop-down displays the number of selected values out of the total available values, for example, 1 of 11 Categories.

Dashboard Listings

The dashboard includes the following listings:

• KRI Breakdown: Displays Alerts, Risk Signals, and RBQM Issues by KRI, including the percentage of total records represented by each record type.
• Sites Breakdown: Displays Alerts, Risk Signals, and RBQM Issues by site, including the percentage of total records represented by each record type.

Navigation and Actions

• Click an arrow in a summary card to open the corresponding records on the Monitoring page. The listing is automatically filtered and / or sorted based on the selected summary. For example, selecting Open Risk Signals with No Response filters the listing to matching records and sorts records with the longest response time first.

• In the KRI Breakdown and Sites Breakdown listings:

  • Click an Alert, Risk Signal, or Issue count to open the Monitoring page, automatically filtered to display the corresponding records.
  • Click a KRI name to open the Sites Overview dashboard with the KRI Details panel open.
  • Click a Site or Country hyperlink to open the corresponding Site or Country Profile dashboard.
• Use the available filters to refine the displayed dashboard data.
• Use the Maximize icon to view a chart or listing full screen.

Note: For details on reviewing and managing Alerts, Risk Signals, and RBQM Issues on the Monitoring page, see the Manage Alerts, Risk Signals, and Issues on the RBQM Risk Signals Monitoring Page article.

Profiles Dashboards

The Profiles section provides KRI performance and risk trends across sites or countries. Select Sites or Countries in the left navigation to open the corresponding Profiles dashboard.

The Site and Country profile dashboards have a similar layout and functionality.

Sites Profile

Countries Profile

Dashboard Components

Both Profile dashboards include:

• A summary table displaying site or country information and current risk scores.
• A KRI Score Distribution chart.
• A KRI Levels over Time chart.

KRI Score Distribution

The KRI Score Distribution chart displays KRI score distribution across all available RBQM Snapshots for the selected site or country.

• A black dot indicates the KRI score for the most recent RBQM Snapshot.
• Hover over chart elements to view additional details.
• Use the available chart controls to zoom, pan, and reset the view.
• Select chart elements to explore KRI results.

Select KRIs in the Site Profile

By default, the Site Profile displays all configured non-CSM KRIs.

If the selected site has Clinical Statistical Monitoring (CSM) KRIs configured, each CSM KRI is available as a separate option in the KRI drop-down. Select a CSM KRI to display data for that KRI and site.

Note: The KRI drop-down is not available in the Country Profile because CSM KRIs are not applicable at the country level.

KRI Levels over Time

The KRI Levels over Time chart displays historical KRI results by RBQM Snapshot date.

By default, the chart displays the 12 most recent RBQM Snapshots. Click the calendar icon to select a date range. If the selected date range contains more than 12 RBQM Snapshots, use the horizontal scrollbar to view additional Snapshots.

• RBQM Snapshot dates display on the x-axis.
• Each KRI displays as a separate row.
• The chart uses color to indicate the KRI risk level for each RBQM Snapshot.
• Alert, Risk Signal, and RBQM Issue indicators display for RBQM Snapshots where records exist.
• Hover over an indicator to identify the associated Alert, Risk Signal, or RBQM Issue.
• Click an indicator to open the corresponding filtered records on the Monitoring page.

Country Details Dashboard

The country dashboard displays a geographic view, KRI summaries, and site-level details.

Access a Country Details Dashboard

1. From the Study Report tab, select a row in the Countries listing. The country card opens.
2. Click the VIEW COUNTRY DETAILS link.

The selected country dashboard opens.

• Use the drop-down next to the country name to switch dashboards.

Country Map

The map displays the selected country with site markers.

• Click the Hide / Show Sites icon to toggle site markers.
• Click the Show World icon to view the global map.
• Click the Continents icon and select a continent to filter the view.
• Click the Create icon to open a menu:
  • Create Issue on selected country
  • Create Risk Signal on selected country

KRIs

• Displays color-coded gauges for each KRI.
• Click a KRI name to open its dashboard.

Sites Listing

Displays:

• Risk Level gauge
• Site Name
• Country Code
• Site ID
• Score
• Trend

Additional actions:

• Click a site row to open the site card.
• Select a site, then click the Create icon to open a menu:
  • Create Issue
  • Create Risk Signal

Site Details Dashboard

Site dashboards display Site Details and Site Indicator Performance.

Access a Site Details Dashboard

1. From a country dashboard, select a site in the Sites listing. The site card opens.
2. Click the VIEW SITE DETAILS link.

The site dashboard opens.

• Use the drop-down next to the site name to switch dashboards.

Site Details

Displays:

• Site Name
• Site ID
• Address
• Country
• Risk Level gauge

Click the Show Issues link to open a filtered RBQM Issues listing.

Site Indicator Performance Chart

• Displays performance charts for configured KRIs.
• Scores display by RBQM Snapshot date.
• Click the Create icon to open a menu:
  • Create Issue
  • Create Risk Signal