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 display study coverage, assessment status, RBQM refresh activity, and Risk Signal and Issue counts.
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.
Access the Risk Management Page
- Click the 9-dot icon to open the Platform Menu.
- 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 access to RACT or RBQM is unavailable, the related card remains visible but displays no data.
Risk Assessment Categorization Tool (RACT) Status Card
- Finalized Versions: Displays the number of finalized RACT assessments for the study. The most recent finalized version is the current assessment.
- Last Final Assessment: Displays the date when the most recent assessment was finalized.
- Create New Assessment: Click the Create New Assessment icon to open the Create New Assessment window.
- Assessment Ongoing: Displays Yes when an assessment is in progress.
- Days Until Reassessment: Displays the number of days until the next reassessment, when applicable.
- Navigation: Click the card to open the Assessments page in RACT.
Risk-Based Quality Management (RBQM) Status Card
- Countries: Displays the number of countries included in the study.
- Sites: Displays the number of sites included in the study.
- Run RBQM Engine: Click the Run RBQM Engine icon to run the RBQM Engine and calculate metrics.
- Study Data Refresh: Displays the date and time of the most recent study data import.
- RBQM Refresh: Displays the date and time of the most recent RBQM Engine run.
- Navigation: Click the card to open 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: Click the search type drop-down and select Study or Program. Enter a study or program name in the Search field, then click the Search icon.
Favorites: Click the Favorites icon to display favorite studies. To add or remove a favorite study, click the Favorites icon for the study.
Sort: Click Sort to open the Sort popout. Configure the following options:
- Sort By: Ascending or Descending
- Arrange By: Study Name, Number of Total Risk Signals, Number of Open Risk Signals, Number of Total Issues, or Number of Open Issues
Filter: Click Filter to open the Filter popout. Filter studies using the following categories:
- 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 the results.
Configuration: Click the Configuration 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 helps ensure accountability and keeps metrics current.
- Monitor the Study Data Refresh and RBQM Refresh timestamps on the RBQM card during each visit to the Risk Management page. Trigger a manual refresh or investigate ETL issues if timestamps drift beyond the expected refresh schedule.
- Synchronize Risk Management workflows and finalize or archive RACT assessments on time to ensure that RBQM monitoring runs against the latest risk definitions. This alignment ensures that proactive planning (RACT) and scheduled analytics (RBQM) reference the same risk environment.
- Re-evaluate KRIs and QTL thresholds after substantial protocol changes, and create a new RACT version when appropriate. Re-baselining helps protect data integrity and keeps monitoring rules aligned with the updated protocol.