Permissions: To review and monitor data in RBQM a user must have Data Central, RBM, and View privileges.
To configure RBQM in Data Central a user must have RBM, Data Central Configure, 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. A dedicated 'Actions' framework, integrated with elluminate's issue functionality, enables the seamless triage and reassignment of issues, based on root cause, to CRAs, Site Monitors, Clinical Data 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 a study card on the Data Central 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: RBQM: Overview, Trial Level Risks, KRIs, Countries, and Sites.

Alternatively, click the 9-dot icon to access the Platform Menu, then select 'Risk-Based Quality Management' under Risk Management. A list of RBQM configured studies will appear; click a study to access its Overview dashboard.

Tip: Click the icon to the right of Risk-Based Quality Management to open the recently viewed study.

Click a section (Overview, Trial Level Risks, KRIs, Countries, Sites) to display the corresponding overview dashboard. The sheet name (at the bottom) will be RBQM.

Dashboard Functionality

Dashboard functionality is consistent across all dashboards. 

• Click hyperlinks to view more specific dashboards, such as site, country, KRI, or risk-specific dashboards (including CTQ and QTL).
• Hover over data points to view details in a tooltip.
• Click and drag on a chart to zoom; click the Zoom Out or Show All Data icon to reset the view.
• Click the Create Issue icon to create issues.
• Use the breadcrumbs (top left) to return to the overview dashboard. 
• Use scrollbars to view all data.

Listings 

RBQM listings use standard elluminate functionality.

• Most columns are resizable, sortable, filterable, and can be fixed.
• Blue badges display the total number of filtered rows.
• Green, yellow, red badges indicate 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 do not get included in scores.
• Hover over a Risk Level gauge to see the risk level (High, Medium, or Low). A critical KRI driving the risk level will be indicated in the tooltip.
• Click the hyperlinked number of open or actioned Issues to open the Issues listing, 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 will 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 your dashboard to compare multiple site or country KRIs.
• Use your mouse wheel to zoom in and out.

Overview Dashboard

The Overview dashboard provides a summary of the study's RBQM data. 

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. 

Country Overview Map

The Country Overview map displays countries color-coded by risk.

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, number of Subjects, and number of KRIs Over Threshold. 

• Click a site row to open its site card. The card displays the Site Score, a list of hyperlinked KRIs, 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, Important icon (if defined as Critical), and color-coded badges showing the number of sites at low, medium, and high risk. 

• Click a KRI Name to open its dashboard.

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). 

Trial Level Risks Overview Dashboard

The Trial Level Risks overview dashboard displays the QTL Overview by default. Clicking the CTQ View toggle (top right) 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)

• Click a QTL name to open its dashboard.
• If the QTL threshold is configured to be dynamic, the threshold line in the chart will reflect the change.

CTQ Overview (click the CTQ View toggle in the top right corner)

This view shows the configured CTQs for the study. If no CTQs are configured, the View CTQ toggle will be 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 (far right) for each CTQ to expand or collapse its associated QTL charts.

Individual QTL Dashboards

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

• The dashboard displays the QTL name at the top. Use the drop-down menu next to the QTL name to view a different QTL's 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 will reflect the change.
• If supporting data is defined for the QTL, click the Supporting Data button, and select from the drop-down menu. The domain listing will open as a floating panel on your dashboard. 
• The shaded zones show when the risk score is in control, approaching the upper and lower limits, and exceeds 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. 

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

KRIs Overview Dashboard

Key Risk Indicators (KRIs) are defined for a study to measure performance at sites. KRIs are configured within Data Central Configuration. The KRI dashboard updates automatically following each regularly scheduled 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 is displayed on the x-axis. 

• Click in a KRI box to open its dashboard.
• Hover over an item in the legend and the markers in the chart highlight.
• Click the Zoom Out icon to see all the outlier markers above the box and whisker; click the Zoom to fit box and whiskers to reset.
• Click an outlier to open the Site or Country KRI card (based on if you are viewing by Sites or by Countries).
• By default, the chart displays by Sites, use the drop-down menu (in the breadcrumb) next to Sites to view by Countries.

KRIs Listing

The KRIs list includes a Risk Level gauge, the number of open and actioned issues, the KRI Name, Category, Current Score, important icon (if defined as Critical), and color-coded badges with the number of sites at low, medium and high risk. 

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

Issues Per KRIs Chart

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

• Hover over the different colors of a bar to see the details in a tooltip.
• Click a color of a bar and the Issues listing opens displaying RBQM issues filtered for that status. 

Individual KRI Dashboards

Individual KRI dashboards will display based on how the scoring was configured. They can be configured using no specific scoring, CSM, or Z Score. 

If Z Score or no specific scoring is selected, the dashboard displays site / country risk over time, sites / countries by risk level, and scores summary per run.

If CSM is used for scoring, the dashboard displays measurement distribution by site, site comparison, and scores summary for most recent run.

• By default, the dashboard displays data by Sites. Use the drop-down menu (in the breadcrumb) next to sites to view by 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's dashboard. A triangle next to a KRI indicates it is marked as critical.

No Specific Scoring Configured

Site / Country Risk over Time Chart

Scores display on the y-axis, run dates display on the x-axis, and each site / country line is identified by a color. 

• Click a site / country in the legend to view only that data in the line graph and listing. The Scores Summary per Run listing will update accordingly; click the Show all Sites / Show all Countries icon to return to the full data view.
• 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 will open as a floating panel on your dashboard. 

Sites / Countries by Risk Level Chart

The risk level pie chart is color-coded by risk (low / medium / high), and markers display the number of sites / countries in each risk category.

• Click a color-coded section of the pie and a pop-up list of sites / countries at that risk level opens. The list includes a risk-level gauge, Site ID (if viewing Sites), hyperlinked site / country Name, and Score. Click the name of a site / country to open its dashboard.

Scores Summary per Run Listing

The Scores Summary per Run listing displays the Risk Level gauge, Site ID (number) / 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

If a KRI is configured to use CSM, the dashboard will display accordingly. In the example below, the Diastolic Blood Pressure (for CSM) KRI was configured to use CSM.

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

The pie chart uses color-coding to distinguish between similar and different sites.

• Click a color-coded section of the pie and a pop-up list of sites / countries at that risk level opens. The list includes a risk-level gauge, Site ID (if viewing Sites), hyperlinked site / country Name, and Score. Click the name of a site / country to open its dashboard.

Scores Summary for most recent Run Listing

The Scores Summary for most recent Run listing displays a risk level gauge, Site ID (number), Site 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).

Countries Overview Dashboard

The Countries Overview dashboard displays a color-coded map, a list of participating countries, and a pie chart showing overall risk.

Countries Map

The Countries Map displays countries color-coded by risk.

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 name to open its dashboard.

Countries Risk Chart

The Countries Risk pie chart is color-coded by risk (low / medium / high), and markers display the number of countries in each category.

• Click a color-coded section of the pie and a pop-up list of countries at that risk level opens. The list includes a Risk Level gauge, a hyperlinked country Name, Score, and Trend. 

Individual Country Dashboards

The individual country dashboard displays a color-coded map of the selected country, a visualization of the KRIs, and a list of participating sites from the selected country.

• The dashboard displays the country name (e.g., United States). Use the drop-down menu next to the country name to select a different country's dashboard.

Country Map

The map displays the selected country with color-coded 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 its dashboard.

Sites Listing

The Sites listing displays a Risk Level gauge, site Name, Country Code, Site ID, Score, and Trend. 

• Click a row to open its site card, displaying the Site Score, a list of hyperlinked KRIs, and a link to View Site Details. A triangle next to a KRI indicates it is marked as critical. Resize the column to see the full KRI name.

Sites Overview Dashboard

The Sites Overview dashboard displays a color-coded overview of sites within a study.

Sites Map

The Sites Map displays countries color-coded by risk.

Sites Listing

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

• Click a row to open a site card displaying the Site Score and gauge, a list of hyperlinked KRIs, and a link to View Site Details. A triangle next to a KRI indicates it is marked as critical.

Sites Risk

The Sites Risk pie chart is color-coded based on risk (low / medium / high), and markers display the number of sites in each risk category.

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

Individual Site Dashboards

Individual site dashboards display the selected site's details and site indicator performance. 

• The dashboard displays the Site number (e.g., Site - 102). Use the drop-down menu next to the site number to view a different site's dashboard.

Site Details

Site details for the selected site include Name, Site (number), Address, Country, risk level gauge, and a hyperlink (Show Issues) to a filtered list of site issues. A triangle next to a KRI indicates it is marked as critical.

Site Indicator Performance Chart

A graph for each KRI displays scores by run date. Use the scrollbar on the right to see all KRI graphs.