Permissions: To review and monitor data in RBQM, a user must have RBQM, Data Central, and View privileges.
To configure RBQM in Data Central a user must have RBQM, Data Central, and Study Configure privileges.

Risk-Based Quality Management (RBQM) supports the tracking and analysis of site and country Key Risk Indicator (KRIs), as well as the management of study Critical to Quality factors (CTQs) and Quality Tolerance Limits (QTLs) within Data Central. Preconfigured dashboards are designed to identify potential risks in study conduct and provide detailed insights into how these risks impact various aspects and locations participating in the study. An Alerts framework, integrated with issue management functionality, supports the triage and reassignment of issues based on root cause to CRAs, Site Monitors, ClinicalData Managers, and other study team members. 

Benefits of RBQM

• Provides a simple, intuitive way for users to discover and monitor risks and actions at the study, site, and country levels.
• Offers flexible configuration of customized critical-to-quality factors, risk tolerance limits, indicators, and actions, globally and per study. 

Access RBQM

There are multiple ways to access RBQM.

To access RBQM from the Platform Menu:

• Click the 9-dot icon, then select Risk Management under Risk Management. The Risk Management Home page opens. From there, click the Risk-Based Quality Management card. This opens the study's RBQM Overview dashboard. The sheet name (bottom left) is labeled RBQM.
• Users can also access the RBQM Overview dashboard by clicking the icon to the right of Risk-Based Quality Management to open the recently viewed study.

To access RBQM from a study card on the Data Central Studies landing page:

• Click the RBQM Direct Link tile. This tile may be on the second page of the study card; click the dot at the bottom of the study card to see additional tiles. This opens the study's Overview dashboard. The sheet name (bottom left) is labeled RBQM.
• Or click the hyperlinked study name, then select RBQM from the left navigation. This expands the left navigation to show RBQM dashboards: Overview Sites / Countries, Trial Level Risks, KRIs, and Study Report.

Select a section from the left navigation to display the corresponding RBQM dashboard. The sheet name (at the bottom) is RBQM.

Navigation

RBQM uses a left navigation panel to access dashboards and views. The panel displays section names by default and can be collapsed into an icon-only sidebar to maximize workspace. 

Links to RACT and Risk Management are located at the bottom of the left navigation, allowing quick access to those modules without leaving the current study context.

When the RBQM panel is closed, the system automatically returns to the Data Central left navigation, enabling smooth navigation between RBQM and Data Central.

Dashboard Functionality

Dashboard functionality is consistent across all dashboards. 

• Select links in the left navigation to open Site, Country, KRI, or Trial Level dashboards, including CTQ and QTL metrics.
• Hover over data points to view details in a tooltip.
• Drag within a chart to zoom. Use Zoom Out or Show All Data to reset the view.
• Use scrollbars to view all data.

Listings 

RBQM listings use standard elluminate functionality.

• Columns are resizable, sortable, and filterable, with the first four columns fixed during horizontal scrolling.
• Blue badges display the total number of filtered rows.

• Green, yellow, and red badges represent the total number of items at low, medium, and high risk; gray badges indicate the number of KRIs with no data available. KRIs with no data are not included in scores.

  

• Hover over a Risk Level gauge to see the risk level (High, Medium, or Low). A critical KRI influencing the risk level is shown both in a tooltip and with a triangle exclamation Warning icon.

• Click the hyperlinked number of open or actioned Issues to view the Issues list, filtered accordingly. Alternatively, right-click to open a context menu and choose whether to open the filtered list on the current sheet or a new sheet. Manage issues easily from the listing.

  Tip: When viewing the details of an RBQM system-generated issue, the details include the KRI or QTL Name, Score, and Risk Level.

Maps

• Hover over a country to view a tooltip showing the country name and score.
• Hover over a small circle to view a tooltip showing the site name and score.
• Use the icons to show or hide sites, show or hide the world, or select a continent from the drop-down menu to view it.
• Click a country or site marker to open its card, displaying the score, a list of hyperlinked KRIs, and a link to view details.
• Pin multiple site or country cards (max 3) to the dashboard to compare multiple site or country KRIs.
• Use the mouse wheel to zoom in and out.

RBQM Overview Dashboards

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

• Both dashboards display subject counts, site and country scores, and KRI results for each configured metric.
• Status icons, trend indicators, and warning icons highlight emerging risk signals. 
• Missing values indicate unavailable data for the selected metric.
• Both dashboards feature a right-side panel showing KRI and QTL details. Click the Details icon to open a panel on the right that displays KRI information not tied to a specific site or country. Clicking a KRI cell for a particular site or country opens the side panel with that site or country’s KRI details.
• The side panel has 2 tabs:
  • KRI Details: Displays site-level thresholds, trend, and pre-configured recommendations.
  • Trial Level Risks: Lists all QTLs, that are available under Trial Level Risks in the left navigation.

RBQM Snapshots

RBQM dashboards support timestamped Snapshots, allowing users to view historical RBQM results from previous runs. Use the RBQM Snapshot drop-down menu in the upper left corner of the dashboard to select a specific Snapshot.

Selecting a Snapshot updates the Overview Sites and Overview Countries dashboards to display the exact RBQM results from that point in time, preserving the original scores even if data or metrics have since changed. RBQM Snapshots assist users in reviewing the data state that caused a concern, supporting traceability, audit readiness, and follow-up actions.

Symbols Used in RBQM Overview Dashboard

   Score increased from last 2 score runs

   Score increased from last score run

   No change / changes within 0.5

   Score dropped from last run

   Score dropped from last 2 score runs

   In Limit

   Exceed lower threshold

   Exceed upper threshold

   Has Open Issues(s)

  Metric itself has been flagged as critical

Tip: Hover over symbols to view descriptive tooltips. Right-click a cell in the listing to open a context menu with options to create a pre-filled Issue for the selected site and metric.

Trial Level Risks Overview Dashboard

The Trial Level Risks overview dashboard displays the QTL Overview by default. Selecting the CTQ View toggle displays the list of CTQs for the study. QTLs can be assigned to CTQs; both measure the overall health of the study. CTQs and QTLs are configured in Data Central Configuration. This dashboard updates automatically following each regularly scheduled RBQM run.

QTL Overview (default view)

• Select a QTL name on the card to open its dashboard. 
• If the QTL threshold is configured to be dynamic, the threshold line in the chart reflects the change.

CTQ Overview

This view shows the configured CTQs for the study. If no CTQs are configured, the View CTQ toggle is grayed out. Expanding a CTQ displays its assigned QTLs. Each CTQ displays the number of associated QTLs in control, approaching limit, and threshold exceeded.

• Click the arrow on the right of a CTQ to expand or collapse its associated QTL charts. 

Individual QTL Dashboards

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

• The dashboard displays the QTL name at the top. Select the drop-down menu next to the QTL name to view a different QTL dashboard.

Tolerance Chart

Scores display on the y-axis, and run dates display on the x-axis. 

• If the QTL threshold is configured to be dynamic, the threshold line reflects the change.
• If supporting data is defined for the QTL, select Supporting Data and select an option from the drop-down menu. The domain listing opens as a floating panel on the dashboard.
• Shaded areas show when the risk score is in control, nearing the upper or lower limits, or exceeding the limit. 

Scores Listing

The Scores listing displays by run date. Columns include the Risk Level gauge, QTL Name, Run Date, Early Action Limit, Tolerance Limit, Score, Status, and Trend Pattern. 

• Select Export to download an Excel file of the listed data.
• Use the Previous / Next Page icons (20 rows display per page).

KRIs Overview Dashboards

Key Risk Indicators (KRIs) are defined for a study to measure performance at sites and countries. KRIs are configured within Data Central Configuration. The KRI dashboard updates automatically following 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

Score Distribution Chart

The Score Distribution box and whisker chart displays at the top of the window. Each KRI displays on the x-axis. 

• Click in a KRI box on the chart to open its individual dashboard.
• Hover over an item in the Legend to highlight corresponding markers in the chart.
• Select Zoom Out to display all outlier markers above the box and whisker. Select Zoom to Fit to reset the view.
• Select an outlier to open the Site or Country KRI card, depending on the selected view.
• By default, the chart displays Sites. Use the left navigation to switch between Sites and Countries.

KRIs Listing

The KRIs listing includes a Risk Level gauge, the number of open issues, the KRI name, category, current score, and an indicator for critical KRIs.

• Click the name of a KRI to open its dashboard.

Issues Per KRIs Chart

The bar chart displays the number of issues for each KRI, color-coded by status. For example, blue represents open issues, red represents answered issues, and green represents closed issues.

• Hover over the different colors of a bar to see the details in a tooltip.
• Select a color segment in the bar 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 scoring is configured, the dashboard displays Site or Country Risk Over Time, Site or Country by Risk Level, and Scores Summary per Run.

When CSM scoring is configured, the dashboard displays Measurement Distribution by Site or Country, Site or Country Comparison, and Scores Summary for the most recent Run.

• By default, the dashboard displays data by Sites. Use the left navigation to switch between Sites and Countries.
• The dashboard displays the KRI name at the top. Use the drop-down menu next to the KRI name to view a different KRI dashboard. A triangle icon next to a KRI indicates the KRI is marked as critical.

No Specific Scoring Configured

Site / Country Risk over Time Chart

Scores display on the Y-axis and run dates display on the X-axis. Each site or country line is identified by a color.

• Select a site or country in the legend to display only that data in the chart and listing.
• The legend displays by default, use the Show / Hide Legend icon to show or hide the legend.
• Click and drag over an area to view only that data; click the Show all data icon to reset the graph.
• If supporting data is defined for the KRI, click the Supporting Data button, and select 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 (low, medium, high).

• Click a section of the pie and a popout list of sites or countries at that risk level opens. The list includes a Risk Level gauge, Site ID (if viewing Sites), Name (hyperlink), and Score. 
  • Click the hyperlink Name of a site or country to open its dashboard.

Scores Summary per Run Listing

This listing displays the Risk Level gauge, Site ID (number) or ISO Code (country), Site or Country Name, Run Date, and Score.

• Click the Export icon to download the latest data, or full history. Options include Export Latest or Export Full History. 
• Use the Preview / Next Page icons (20 rows display per page) to navigate the rows.

CSM Scoring Configured

When a KRI is configured to use CSM scoring, the dashboard displays measurement distributions, site comparison, and scores summarized for the most recent run. Note that countries do not support CSM or Z scoring.

Measurement Distribution by Site Chart

Measurements display on the y-axis, site numbers on the x-axis, and each site is identified with a box and whisker.

• The legend displays by default, use the Show / Hide Legend icon to show or hide the legend.
• Click and drag over an area to view only that data; click the Show all outliers icon to reset the graph.

Site Comparison Chart

This pie chart uses color-coding to distinguish between Similar and Different sites.

• Click a color-coded section of the pie and a popout list of sites at that risk level opens. The list includes a Risk Level gauge, Site ID, Name (hyperlink), and Score. 
  • Click the hyperlink name of a site to open its dashboard.

Scores Summary for most recent Run Listing

This listing displays a Risk Level gauge, Site ID (number), Site Name, Run Date, and Score. 

• Click the Export icon to download. Options include Export Latest or Export Full History.
• Use the Preview / Next Page icons (20 rows display per page).

Study Report

The Study Report 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 (default view)

• QTL Gauges: Color-coded gauges at the top of the dashboard represent each defined QTL. Red indicates tolerance exceeded; yellow, approaching the limit; and green, in control. A triangular marker shows the current status. Below, color-coded pills display the status (In Control, Approaching Limit, or Tolerance Exceeded), and the change in status (Increasing, Decreasing, or Steady).
• Click a QTL name to open the Trial Level Risks dashboard, displaying the selected QTL dashboard.

CTQ Overview: Access by clicking the 'CTQ View' toggle in the top right corner.

• CTQ Gauges: Color-coded gauges at the top of the dashboard represent each defined CTQ. Red indicates threshold exceeded; yellow, approaching the limit; and green, in control.
• Click a CTQ name to open the Trial Level Risks dashboard, displaying the selected CTQ (with its assigned QTLs) at the top and other CTQs below. 

Sites Listing

The listing displays sites by risk level (high to low). Columns include a Risk Level gauge, the hyperlinked number of open and actioned Issues, Site Name, Site ID, Subjects (count), and KRIs Over Threshold (count). 

• Click a site row to open its site card. The card displays the Site Score, KRIs list with hyperlinks, and a link to View Site Details. 

KRIs Listing

The listing displays the study's KRIs. Columns include a Risk Level gauge, the hyperlinked number of open and actioned Issues, KRI Name, Category, Current Score, Critical (triangle icon), and color-coded badges showing the number of sites at low, medium, and high risk. 

• Click a KRI Name to open its dashboard.

Countries Listing

The list of countries participating in the study, displaying a Risk Level gauge, the country Name, country Code, Score, and the number of sites at high, medium, and low risk.

• Click a country row to open its country card. The card displays the Country Score, a list of hyperlinked KRIs, and a link to View Country Details. 

Risk Summary Report

Open the Risk Summary Report in a separate window using the Report icon (top right). Print the report to a PDF using the Print button (top right). The report includes sections for Report Details, CTQ Summary, QTL Summary, Site Summary, Country Summary, and KRI Summary.

Individual Country Dashboards

The individual country dashboard displays a color-coded map of the selected country, key risk indicator (KRI) summary metrics, and a listing of participating sites.

To access a country dashboard, select Overview Countries from the left navigation, then select a country. Users can also use the drop-down menu next to the country name to pick a different country's dashboard.

Country Map

The map displays the selected country with markers for each site.

KRIs

A visualization of color-coded gauges for each KRI for the selected country. Easily identify the country's score and risk for each KRI. Click the KRI name to open the KRI's dashboard.

Sites Listing

Displays a Risk Level gauge, Site Name, Country Code, Site ID, Score, and Trend. Click a site row to open its site card. 

Individual Site Dashboards

Individual site dashboards display Site Details and Site Indicator Performance, a line chart.

To access a site dashboard, select Overview Sites from the left navigation, then select a site. Users can also use the drop-down menu next to the site name to pick a different site's dashboard.

Site Details

Site Details includes Name, Site (number), Address, Country, Risk Level gauge, and Show Issues (hyperlink) to a filtered list of site issues. 

Site Indicator Performance Chart

Displays a performance chart for each configured KRI, showing scores by run date. Use the scrollbar to view all KRI charts. 

Legend

Use the Legend icon in upper right corner of page to open the legend that displays the symbols used on the RBQM overview dashboards, and what they mean.