Permissions: RACT Assessment Read Only allows read-only access to RACT via the RACT card in Risk Management for studies to which the user has permissions.
RACT Assessment Read Write allows users read / write access to the RACT via the RACT card in Risk Management for studies for which the user has permissions.
RBQM and Data Central together allow users access to RBQM dashboards and RBQM-related Issues through the RBQM and RBQM Issues cards in Risk Management for studies to which the user has permissions.

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 three status cards: one for the Risk Assessment Categorization Tool (RACT), one for Risk-Based Quality Management (RBQM), and one summarizing RBQM Issues. 

Together, these three cards display key study metrics, such as site and country coverage, assessment status and versions, RBQM refresh timestamps, and RBQM issue counts, enabling users to quickly assess study risk status. This way, users can take action without leaving 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 the user does not have access to RACT or RBQM, the corresponding card remains visible but shows no data.
  • RACT Status Card:
    • Finalized Versions: Shows the count of completed RACT assessments for the study; the latest finalized version is considered the current assessment.
    • Last Final Assessment: Shows the most recent date the assessment was finalized.
    • Start New Assessment: Clicking this icon initiates a new version of an assessment.
    • Assessment Ongoing: Displays as Yes when an assessment is in progress.
    • Days Until Reassessment: If applicable, this field displays the number of days until the next reassessment.
    • Navigation: Click the card to access the Assessments page in the 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 RBQM Engine: Runs the RBQM 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 RBQM Engine was executed.
    • Navigation: Click the card to access the RBQM Overview Dashboard for the study. 

    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 open the Issues listing in RBQM filtered for open RBQM issues in the study. 

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.