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 site and country Key Risk Indicator tracking and analysis, as well as the ability to manage study Quality Tolerance Limits from within Data Central. Preconfigured dashboards are optimized to identify possible risks in the conduct of a study and provide detailed insights into how a risk impacts different aspects of or locations participating in a study. Issues identified in RBQM are handled using an "Actions" framework that is supported by elluminate's Issue functionality. Users can seamlessly triage and reassign issues based on the root cause to CRAs, Site Monitors, Clinical Data Managers, or other study team members.

Benefits of RBQM

• Provides a simple and intuitive way for users to discover risks at the study, site, and country levels; and to view and monitor actions. 
• Offers the flexibility to configure customized risk tolerance limits, indicators, and actions globally or per study. 

Access RBQM

There are multiple ways to access RBQM.

From a study card on the Data Central Landing Page:

• Click on the RBQM Direct Link tile. This tile may be found on the second page of the study card. Click the dot at the bottom of the study card to see additional tiles. This will bring you to the study's Overview dashboard. The sheet name (bottom left) is labeled RBQM.
• Or click on the hyperlinked study name and click RBQM in the left navigation. The left navigation expands displaying sections within RBQM: Overview, QTLs, KRIs, Countries, and Sites.

Alternatively, click on the 9-dot icon to access the Platform Menu and access RBQM by clicking on 'Risk-Based Quality Management' under Risk Management. A list of RBQM configured studies will display on the right side of the menu. Click on a study to access that study's Overview dashboard.

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

Click on a section (Overview, QTLs, KRIs, Countries, Sites) and that overview dashboard displays. The sheet name will be RBQM.

From any dashboard a user can hover over a section, hyperlink, or data point, and click to drill further into the details, such as access a site, country, KRI, or QTL specific dashboard. When viewing details, use the breadcrumbs shown at the top left to return to the associated overview dashboard. 

The current RBQM dashboard in view opens on the sheet labeled RBQM (bottom left).

Overview Dashboard

The Overview dashboard provides an overall summary of your RBQM data. 

QTL Overview

• Across the top of the dashboard are color-coded gauges for each QTL defined for the study. Red: Tolerance Exceeded, Yellow: Approaching Limit, and Green: In Limits. It also displays the change status, such as Increasing, Decreasing, or Steady. 
• Click on the QTL name to open that QTL dashboard.

Country Overview

The Country Overview map displays countries color-coded based on identified risk.

• Hover over a country to view a tooltip displaying the country name and score.
• Hover over the small circles to view a tooltip displaying the site name and score.
• Use the icons to Show / Hide Sites, Show / Hide World, and Continents.
• Click on a country or site marker and the country / site card opens with the country / site score and gauge, a list of hyperlinked KRIs, and a link to View Country / Site Details. 
• Pin opened country or site cards (from the map) to your dashboard to compare multiple country or site KRIs.
• Use your mouse wheel to zoom in or out on a map.

Site Summary

The Site Summary is listed by risk level (high to low) and displays a Risk Level gauge, Site ID, site Name, number of Subjects, number of KRIs Over Threshold, hyperlinked number of Issues, and Trend line. 

• Hover over a Risk Level gauge to view the risk level: High, Medium, or Low. If a KRI is marked as critical and the current risk level is driven by a KRI marked as critical, the hover over is, 'Current Risk Level is driven by a Critical KRI.'
• Click on a row and a site card opens with the Site Score and gauge, a list of hyperlinked KRIs, and a link to View Site Details. In the list of KRIs, a triangle symbol next to a KRI indicates it is marked as critical.
• Colored badges indicate how many total sites, and number of sites at low, medium, and high risk.
• Click on the hyperlinked number of Issues and the Issues listing opens filtered for those issues. Easily manage issues from the listing.
• Use the scroll bars to see all columns and items listed.

KRI Summary

The KRI Summary is listed by KRI and displays a Risk Level gauge reflecting the current risk level, the KRI Name, Category, hyperlinked number of Issues, checkmark if defined as Critical, Sites Threshold Count, Current Score, and Trend line. 

• Next to the KRI Summary title, colored badges indicate how many total KRIs, and number of KRIs at low, medium, and high risk.
• Click on the Name of a KRI and that KRI dashboard opens.
• Click on the hyperlinked number of Issues and the Issues listing opens filtered for those issues. Easily manage issues 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.

• Use the scroll bars to see all columns and items listed. 

QTLs Overview Dashboard

Quality Tolerance Limits (QTLs) are defined for a study to measure the overall health of the study. QTLs are configured within Data Central Configuration. Based on QTL configuration, the QTL dashboard updates when RBQM is run at regular intervals. A color-coded gauge and line graph display for each QTL.

• Click on the hyperlinked QTL name and that QTL dashboard opens.
• Hover over a marker on the line graph to view the run date and score in a tooltip.
• Create an issue by clicking the Create Issue icon at the top right of each QTL line graph.
• If the QTL threshold is configured to be dynamic, the threshold line will reflect the change.

Individual QTL Dashboards

Individual QTL dashboards display tolerance limits, all current / historic scores, and a current score gauge.

• From the breadcrumbs click the hyperlinked QTLs Overview to return to that dashboard.
• The name of the QTL dashboard in view displays. Click the drop-down next to the name of the QTL and select a different QTL dashboard.

Tolerance

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.
• Hover over a marker on the line to view the run date and score in a tooltip.
• Click and drag over an area to view only that data.
• Click the Zoom Out icon to reset the graph.
• Create an issue by clicking on the Create Issue icon.
• If supporting data is defined for the QTL, click the Supporting Data button, and select from the drop-down. The domain listing will open as a floating panel on your dashboard. 

Scores

The Scores listing displays the Risk Level gauge, QTL Name, Run Date, Early Action Limit, Tolerance Limit, Score, Status, and Trend Pattern. The number in the blue badge displays the total number of rows.

• Hover over a Risk Level gauge to view the risk level: High, Medium, or Low.
• Click the Export icon to download an Excel file of the listed data.
• Use the scrollbar on the right to see items listed. 
• Use the Preview / Next Page icons (20 rows display per page).
• Create an issue by clicking on the Create Issue icon.

KRIs Overview Dashboard

Key Risk Indicators (KRIs) are defined for a study to measure performance at sites. KRIs are configured within Data Central Configuration. Based on KRI configuration, the KRI dashboard updates when RBQM is run at regular intervals. 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

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

• Hover over a marker to see details in a tooltip.
• Click within a box and that KRI dashboard opens.
• 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 on an outlier to open the Site or Country KRI card (based on if you are viewing by Sites or by Countries).
• Click the drop-down in the breadcrumbs to view by Sites or Countries.

KRI Summary

The KRI Summary is listed by KRI and displays a Risk Level gauge reflecting the current risk level, the KRI Name, Category, hyperlinked number of Issues, checkmark if defined as Critical, Sites Threshold Count, Current Score, and Trend line. 

• Next to the KRI Summary title, colored badges indicate how many total KRIs, and number of KRIs at low, medium, and high risk.
• Click on the Name of a KRI and that KRI dashboard opens.
• Click on the hyperlinked number of Issues and the Issues listing opens filtered for those issues. Easily manage issues from the listing.
• Use the scroll bars to see all columns and items listed. 

Issues Per KRIs

A 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 on 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.

• From the breadcrumbs click the hyperlinked KRIs Overview to return to that dashboard.
• By default, the dashboard displays data by Sites. Click the drop-down next to Sites and select Countries to view data by Countries.
• The name of the KRI dashboard in view displays. Click the drop-down next to the name of the KRI to select a different KRI dashboard. In the drop-down list of KRIs a triangle symbol next to a KRI indicates it is marked as critical.

No Specific Scoring Configured

Site / Country Risk over Time

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

• Hover over a line to see the details in a tooltip.
• Click on a site / country in the legend to view only that site / country data in the line graph and the listing (the Scores by Summary per run listing updates to show only that site / country).
• Click the Show all Sites / Show all Countries icon to see all data.
• 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.
• Create an issue by clicking on a site / country and then clicking on the Create Issue icon.
• 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

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

• Click on a color-coded section of the pie and a list of sites / countries at that risk level opens. The list includes a hyperlinked site / country Name, Score, and Trend line. Click the hyperlinked name of a site / country and that site / country dashboard opens.

Scores Summary per Run

The Scores Summary per Run listing displays the Risk Level gauge, Site ID (number) / ISO Code (country), Site or Country Name, Run Date, Score, and Trend line. The number in the blue badge displays the total number of rows.

• Click the Export icon to download the latest data, or full history. Options include Export Latest or Export Full History.
• Use the scroll bars to see all columns and items listed. 
• Use the Preview / Next Page icons (20 rows display per page).

CSM Scoring Configured

If a KRI was 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

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

• Hover over a box to see the details in a tooltip.
• 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.
• Create an issue by clicking on a site box and then clicking on the Create Issue icon.

Site Comparison

The pie chart is color-coded based on sites that are similar or different.

• Click on a color-coded section of the pie and a list of sites in that category opens. The list includes a hyperlinked site Name, Score, and Trend line. Click the hyperlinked name of a site and that site dashboard opens.

Scores Summary for most recent Run

The Scores Summary for most recent Run listing displays the Site ID (number), Site Name, Run Date, Score, and Trend line. Each listed item is color-coded by risk, red / high, yellow / medium, and green / low. The number in the blue badge displays the total number of rows.

• Click the Export icon to download the latest data, or full history. Options include Export Latest or Export Full History.
• Use the scroll bars to see all columns and items listed. 
• Use the Preview / Next Page icons (20 rows display per page).

Countries Overview Dashboard

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

Countries Map

The Countries Map displays countries color-coded based on identified risk.

• Hover over a country to view a tooltip displaying the country name and score.
• Use the icons to Show / Hide Sites, Show / Hide World, and Continents.
• Click on a country and a card opens with the Country Score, a list of hyperlinked Country Level Indicators, and a link to View Country Details.
• Pin multiple country cards to your dashboard to compare multiple country KRIs.
• Create an issue by clicking on a country and then clicking the Create Issue icon.
• Use your mouse wheel to zoom in or out on a map.

Countries

A list of hyperlinked Countries displays trend details. Columns include a Risk Level gauge reflecting the current risk level, the Name of the country, country Code, Score, Sites Threshold Count, and Trend line. 

• The number in the blue badge provides the Total Countries.
• Click on the hyperlinked Country name and that country's dashboard opens.
• Create an issue by clicking in a row and then clicking the Create Issue icon.

Countries Risk

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

• Click on a color-coded section of the pie and a list of countries at that risk level opens. The list includes a hyperlinked country Name, Score, and trend line. Click the hyperlinked name of a country and that country dashboard opens.

Individual Country Dashboards

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

• From the breadcrumbs click the hyperlinked Countries Overview to return to that dashboard.
• The name of the country dashboard in view displays (e.g., United States). Click the drop-down next to the name of the country and select a different country dashboard.

Country Map

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

• Hover over the country to view a tooltip displaying the country name and score.
• Hover over a color-coded site marker to view a tooltip displaying site name and score.
• Click on a site marker to open the site card, pin multiple site cards to your dashboard to compare multiple site KRIs.
• Use the icons to Show / Hide Sites, Show / Hide World, and select from the list of Continents.
• Create an issue on the selected country by clicking the Create Issue icon.
• Use your mouse wheel to zoom in or out on a map.

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 on the hyperlinked KRI name and the individual KRI dashboard opens.

Sites

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

• Click on a row and a card opens with the Site Score, a list of hyperlinked KRIs, and a link to View Site Details. A triangle symbol next to a KRI indicates it is marked as critical.
• Use the scrollbar on the right to see all items listed. 
• Create an issue by selecting a row and then clicking the Create Issue icon.

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 based on identified risk.

• Hover over a country to view a tooltip displaying the country name and score.
• Hover over the small circles to view a tooltip displaying the site name and score.
• Use the icons to Show / Hide Sites, Show / Hide World, and Continents.
• Click on a country and a card opens with the Country Score and gauge, a list of hyperlinked KRIs, and a link to View Country Details. A triangle symbol next to a KRI indicates it is marked as critical.
• Pin multiple country cards (max 3) to your dashboard to compare multiple country KRIs.
• Click on a site and a card opens with the Site Score and gauge, a list of hyperlinked KRIs, and a link to View Site Details. A triangle symbol next to a KRI indicates it is marked as critical.
• Pin multiple site cards (max 3) to your dashboard to compare multiple site KRIs.
• Create an issue by clicking on a country or site, and then clicking the Create Issue icon.
• Use your mouse wheel to zoom in or out on a map.

Site Summary

The Site Summary is listed by risk level (high to low) and displays a Risk Level gauge, Site ID, site Name, number of Subjects, number of KRIs Over Threshold, hyperlinked number of Issues, and Trend line. 

• Hover over a Risk Level gauge to view the risk level: High, Medium, or Low. If a KRI is marked as critical and the current risk level is driven by a KRI marked as critical, the hover over is, 'Current Risk Level is driven by a Critical KRI.'
• Click on a row and a site card opens with the Site Score and gauge, a list of hyperlinked KRIs, and a link to View Site Details. In the list of KRIs, a triangle symbol next to a KRI indicates it is marked as critical.
• Colored badges indicate how many total sites, and number of sites at low, medium, and high risk.
• Click on the hyperlinked number of Issues and the Issues listing opens filtered for those issues. Easily manage issues from the listing.
• Use the scroll bars to see all columns and items listed.

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 on a color-coded section of the pie and a list of sites at that risk level opens. The list includes a hyperlinked site Name, Score, and Trend line. Click the hyperlinked name of a site and that site dashboard opens.

Individual Site Dashboards

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

• From the breadcrumbs click the hyperlinked Sites Overview to return to that dashboard.
• The Site number of the dashboard in view displays (e.g., Site - 102). Click the drop-down next to the site number and select a different site 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 symbol next to a KRI indicates it is marked as critical.

Site Indicator Performance

A graph for each KRI displaying scores by run.

• Hover over a marker to view a tooltip displaying the Run Date, and Score.
• Use the scrollbar on the right to see all KRI graphs.
• Create an issue by clicking the Create Issue icon.