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

Overview of Risk Management

On the Risk Management page, each study includes three status cards:

• Risk Assessment Categorization Tool (RACT)
• Risk-Based Quality Management (RBQM)
• Risk Signals

These cards provide key metrics such as study coverage, assessment status, RBQM refresh activity, and counts of Risk Signals and Issues, enabling rapid assessment of study risk status.

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 enable RACT, RBQM, or both based on study needs.

Note: In Study Configuration, on the Settings tab, Risk Based Quality Management (RBQM) & Risk Assessment & Categorization Tool (RACT) must be enabled.

Risk Management Workflow

Risk Management uses a structured workflow to identify, evaluate, and manage study risk.

• Risk Alerts are generated automatically by the RBQM Engine when thresholds are exceeded.
• Risk Alerts can be promoted to Risk Signals for evaluation and root cause analysis.
• Risk Alerts or Risk Signals can be promoted to Issues for formal tracking and resolution.

This workflow supports consistent identification, investigation, and management of study risk across RACT and RBQM.

Assess the Risk Management Page

1. Click the 9-dot icon to open the Platform Menu.
2. Select Risk Management under Risk Management. The Risk Management page opens.
   

Review the Study Section

The study section provides a summary view of study details and activity. Each study displays in a dedicated section that includes the following:

• Study and program name
• Total sites
• Enrolled subjects
• Favorite indicator

Status Cards

Each study section contains three status cards: RACT, RBQM, and Risk Signals.

Each status card provides key metrics and quick access to related functionality.

Note: If a user does not have access to RACT or RBQM, the related 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.
• Create New Assessment: Click the icon to initiate a new assessment version.
• 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 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: Click the icon to run the RBQM Engine and calculate the metrics.
• Study Data Refresh: Displays the most recent date and time that study data were imported.
• RBQM Refresh: Displays the most recent date and time that the RBQM Engine was run.
• Navigation: Click the card to access the RBQM Overview dashboard for the study. 

Risk Signals Status Card

• Total Signals: Displays the total number of Risk Signals for the study.
• Open Signals: Displays the number of open Risk Signals.
• Total Issues: Displays the total number of Issues associated with RBQM.
• Open Issues: Displays the number of open RBQM Issues.
• Navigation: Click the card to open the Risk Signals view in RBQM. 

Master Header

The master header provides controls to search, filter, and manage studies.

Search: Use the drop-down to choose either Study or Program to search by. Enter the study or program name in the Search field and click the Search icon.

Favorites: Click the star icon to filter favorite studies. To favorite a study, click the star icon in the top right corner.

Sort: Click to open a popout with sorting options, including Sort By (Ascending, Descending) and Arrange By (Study Name, Number of Total Risk Signals, Number of Open Risk Signals, Number of Total Issues, Number of Open Issues) options.

Filter: Use the Filter popout to refine results:

• RACT: Last Final Assessment, Assessment Ongoing, Days Until Reassessment
• RBQM: Study Data Refresh, RBQM Refresh
• Risk Signals: Last Risk Signal, Days Since Last Response

Select a category, then enter filter criteria to refine results.

Configuration: Click the gear icon to open the Risk Management Configuration page.

Notifications: Click the Notifications icon to open the Notifications window.

Help: Click the Help icon to access the Help Center, Learning Portal, and contact information.

Best Practices

• Assign an owner for each study assessment and schedule regular reviews that align with 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.
• Substantial protocol changes 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.