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 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 or Risk Signals card.

RBQM Navigation

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

• Select an item in the left navigation to open the corresponding dashboard or profile.
• Click the Toggle Side Navigation icon to collapse or expand the panel.
• Hover over icons to view tooltips when the panel is collapsed.
• Click the X to close the RBQM navigation panel and return to the Data Central left navigation.

Links to RACT and Risk Management are available at the bottom of the left navigation for direct access without leaving the study.

RBQM Dashboards

RBQM includes the following dashboards and views:

• Sites Overview
• Countries Overview
• Trial Level Risks
• Sites KRIs
• Countries KRIs
• Study Report
• Risk Signals
• Site and Country Profiles

All dashboards use consistent interaction patterns for filtering, navigation, and data exploration.

Dashboard Functionality

General 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.

In the Sites Overview, Countries Overview, and Profile dashboards, users can right-click a row in a table to create an Issue or Risk Signal.

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 Issues listing as a floating panel.
• Right-click a hyperlinked Issue count to open a context menu and select View Issues to open the Issues listing in a floating panel, or select Open in New Sheet to open the Issues listing in a new sheet.

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 menu.
• 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 runs.

Sites Overview

Countries Overview

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 is unavailable for a metric.

Click Legend to view icon definitions used in the dashboard.

KRI and Trial Level Risk Details

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

• Click the Details icon in a KRI header to open the details panel with KRI information 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 tab
  • Displays thresholds, trend, and configured recommendations.
• Trial Level Risks tab
  • Lists QTLs available under Trial Level Risks in the left navigation.

Navigation and Actions

• The Site ID column in Sites Overview and the Country column in Countries Overview link to the corresponding profiles.
• Right-click a row to open a context menu and select Create Issue or Create Risk Signal.

RBQM Snapshots

RBQM dashboards support timestamped Snapshots to review historical results.

• Use the RBQM Snapshot drop-down to select a Snapshot.

Selecting a 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

Trial Level Risks Overview 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 measure overall study health. CTQs and QTLs are configured in Data Central Configuration.

The dashboard updates automatically after each scheduled RBQM run.

QTL Overview

• Displays all configured QTLs.
• Select a QTL name to open its individual dashboard.
• If a QTL uses a dynamic threshold, the threshold line in the chart updates accordingly.
• Click the Create (plus sign) icon to open a menu, then select Create Issue or Create Risk Signal.

CTQ View

• If no CTQs are configured, the CTQ View toggle is unavailable.
• Click the arrow next to a CTQ to expand or collapse associated QTL charts.

• Displays configured CTQs for the study.
• Each CTQ displays counts of QTLs 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.
• Run 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 menu.

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

Shaded areas indicate risk levels:

• In Control
• Approaching Limit
• Tolerance Exceeded

Scores Listing

The Scores listing displays results by run date.

Columns include:

• Risk Level gauge
• QTL Name
• Run 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 page icons to navigate results (20 rows per page).
• Click the Create (plus sign) icon to open a menu, then select Create Issue or Create Risk Signal.

KRIs Overview 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 run.

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 Issues
• Number of actioned 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 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 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.
• Run 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 (plus sign) 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
• Run Date
• Score

Additional actions:

• Click the Export icon to download data:
  • Export Latest
  • Export Full History
• Use the Previous and Next page 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 run.

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 (plus sign) 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
• Run Date
• Score

Additional actions:

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

Study Report

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
• Critical indicator
• Risk distribution 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
• Risk distribution 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

Individual Country Dashboards

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

Access a Country 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 (plus sign) 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 (plus sign) icon to open a menu:
  • Create Issue
  • Create Risk Signal

Individual Site Dashboards

Individual Site dashboards display Site Details and Site Indicator Performance.

Access a Site 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 Issues listing.

Site Indicator Performance Chart

• Displays performance charts for configured KRIs.
• Scores display by run date.
• Click the Create (plus sign) icon to open a menu:
  • Create Issue
  • Create Risk Signal