Permissions: To access Risk Management, users must have RACT Assessment Read Only / Read Write privileges assigned to a study and / or the RBQM and Data Central privileges assigned to a study. 

Note: The former RBM module has been retired. Risk Management now manages the RACT and RBQM.

elluminate's Risk Management centralizes the configuration and visibility of study-level quality and safety metrics. On the Risk Management page, each study is accompanied by a pair of status cards, one for the Risk Assessment Categorization Tool (RACT) and one for Risk-Based Quality Management (RBQM). A single click on the RACT card opens the latest assessment (or launches a new one), while a single click on the RBQM card opens the RBQM Overview and the Run icon lets users trigger an immediate engine run. Together, the cards surface key study metrics, such as site count, last assessment version, and refresh timestamps. This way, users can act without having to leave the page.

RACT supports protocol-level risk identification, scoring, and mitigation planning before subject enrollment and throughout the study's execution. RBQM conducts ongoing, data-driven monitoring on a schedule to identify emerging risks at the site, country, and study levels through Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).

RACT and RBQM together deliver an integrated framework that links proactive planning and scheduled monitoring. RACT or RBQM can also operate independently alongside third-party solutions, allowing clients to license only the features they need.

Note: In the study's details settings, the Risk Based Quality Management (RBQM) & Risk Assessment & Categorization Tool (RACT), must be enabled.

Assess the Risk Management Page

• Click the 9-dot icon to open the Platform Menu.
• Select Risk Management under Risk Management from the left side of the menu. The Risk Management page opens.
  
• Each study with RBQM and RACT enabled is displayed in a dedicated section on the Risk Management page. This section shows the study and program names, the total number of sites, and the number of enrolled subjects. A star icon in the top-right corner indicates favorites. There are also three status cards within the study section: for RACT, RBQM, and RBQM Issues. If one of the features is not licensed, its card remains visible but shows no data.
  • RACT Status Card:
    • Finalized Versions: This number indicates the number of times the assessment has been revised and finalized. The current finalized version is used for the assessment.
    • Last Final Assessment: Shows the most recent date the assessment was finalized.
    • Start New Assessment: Clicking this icon will initiate a new version of an assessment.
    • Assessment Ongoing: Will display as Yes or No.
    • Days Until Reassessment: If applicable, this field displays the number of days until the next reassessment.
    • Navigation: Click the card to access the study in RACT.

  • RBQM Status Card:

    • Countries: Shows the number of countries involved in the study.
    • Sites: Shows the number of sites involved in the study.
    • Run RBM Engine: Runs the engine to calculate the metrics.
    • Study Data Refresh: The latest date and time when the study data was imported.
    • RBQM Refresh: The most recent date and time when the RBM Engine was executed.
    • Navigation: Click the card to access the study in the RBQM Dashboard.

    RBQM Issues Status Card:

    • Totals: Displays the total number of issues originating from RBQM.
    • Open: Shows the number of open RBQM issues.
    • Past Due Issues: Displays the number of overdue RBQM issues.
    • Navigation: Click the card to access the study's issues in the RBQM Dashboard.

Risk Management Page Master Header

• Filter: Use the popout menu to filter RACT cards by Last Final Assessment, Assessment Ongoing, and Days Until Reassessment. Users can filter the RBQM cards by Study Refresh Date or RBQM Refresh.
• Search: Use the drop-down to choose either Study or Program to search by. Enter the study or program name in the textbox and click the Search icon.
• Favorites: Click the star to turn it solid, filtering favorites.
• Configuration: Click the gear icon to open the risk management configuration page.
• Notifications: This opens the notifications window for the logged-in user.
• Help: Access extensive, robust help and support from eCS, including the Help Center, Learning Portal, and contact information.

Risk Management Best Practices

• Assign an owner for each study assessment and schedule regular reviews that follow RACT reassessment intervals and RBQM engine runs. Consistent ownership ensures accountability and keeps metrics current.
• Monitor the Study Data Refresh and RBQM Refresh timestamps on the RBQM card during every Risk Management page visit. Trigger a manual refresh or investigate ETL issues whenever timestamps drift beyond the expected refresh schedule.
• Synchronize risk management workflows and finalize or archive RACT assessments on time, ensuring RBQM monitoring runs against the latest risk definitions. This coupling ensures that proactive planning (RACT) and scheduled analytics (RBQM) reference the same risk environment.
• Any substantial changes to the step-by-step procedures of protocols should prompt a new RACT version and re-evaluation of KRIs or QTL thresholds. Re-baselining protects data integrity and ensures that monitoring rules remain aligned with the updated protocols.