Permissions: RACT Assessment Read Only: View assessments and exports.
RACT Assessment Read Write: Create, edit, archive, and finalize assessments and risks. 
Risk Management Configuration: Configure and manage CTQs, Considerations, Risk Libraries, KRIs, QTLs, Functional Plans, Critical Data, Critical Processes, and Alerts.

The Risk Assessment and Categorization Tool (RACT) supports the identification, assessment, and ongoing review of risks associated with a clinical study. It supports structured review and approval workflows, collaboration through comments and activity tracking, and documentation of mitigation and contingency actions to ensure traceability and alignment with industry best practices.

RACT features:

• Assess initial study risks and perform ongoing reviews at defined intervals or when protocol changes occur.
• Identify and track critical data and processes by linking risks to relevant critical items.
• Review identified risks and assessment scores to support analysis across assessment versions.
• Use Risk Libraries with AI-assisted generation to select a preconfigured risk and generate an if / due to / then statement.
• Attach predefined critical data / processes, functional plans, KRIs, and QTLs to the RACT Assessment.
• Define and track contingency actions to ensure continuity of response when risks are realized despite mitigation.
• Support a configurable review and approval workflow with defined roles, staged progression, and full traceability across the assessment lifecycle.
• Capture structured collaboration and communication through the Comments & Activities panel, including feedback, @mentions, and workflow activity tracking.
• Maintain structured assessment documentation, including version history, protocol changes, and audit-ready change tracking.
• Add new selectable options directly within supported multi-select fields during assessments, based on configuration privileges.
• Track risks using a locked global Risk ID for traceability and a study-level Risk Assessment ID for identification within assessments. 
• Integrate with the Integrated Data Review Plan (IDRP) to align risks with related Review Objectives in Data Central.

Note: RACT supports a governed risk assessment process by combining structured workflows, collaborative review, and standardized documentation. Configuration is required once in Risk Management Configuration, and all configured items, including CTQs, QTLs, KRIs, and Critical Data / Processes, are global and available across studies.

Access the RACT

1. Click the 9-dot icon to open the Platform Menu.
2. Select Risk Management under Risk Management.
3. The Risk Management page opens. Locate the study and click the RACT card.

OR

1. Select Risk Assessment & Categorization Tool under Risk Management.
2. Select a study from the list on the right side of the Platform Menu, or click the study icon next to Risk Assessment & Categorization Tool to open the most recently viewed study.

The RACT page opens for the selected study.

Tip: Links to RBQM and Risk Management are available in the left navigation. Use these links to navigate between Risk Management, RACT, and RBQM.

RACT Page

The RACT page opens for the selected study and displays the Assessments tab by default in the left navigation. The page lists all assessment versions for the study, including status, settings, and key details. The Archived and Risk Summary views are also available in the left navigation for access to archived assessments and consolidated risk data.

Note: Listings in the Assessments, Archived, and Risk Summary views support standard elluminate functionality, including sorting, filtering, resizing, and fixing columns. A blue badge in the listing header indicates the number of rows in the current filtered view. Filtered columns display a solid filter icon, and the Filters icon in the toolbar turns solid when filters are active. Click the icon to clear all filters or remove specific filters.

Assessments

The Assessments tab displays all assessment versions for the selected study.

Use Page Actions

• Create Assessment: Create a new assessment version and open it in edit mode. If an active draft exists, it is overwritten.
• Archive: Archive selected finalized versions. Archived versions cannot be recovered.
• Compare: Compare two selected finalized versions side by side.
• Filters: View or clear active column filters. The icon displays as solid when filters are applied.

Review Assessment Versions

• Version: Click the link to open the assessment version. Displays as Draft until finalized and named.
• Status:
  • In Progress: Assessment is in progress and can be edited until it is finalized.
  • Pending Review: Assessment is submitted for review. All assigned Reviewers must complete their review or request revisions before the assessment can continue.
  • Pending Approval: Assessment is submitted for approval. All assigned Approvers must complete their approval or request revisions before the assessment can continue.
  • Pending Finalization: All required review and approval steps are complete, and the assessment is ready for the Owner to finalize. The assessment is read-only and can no longer be edited.
  • Finalized: Assessment is complete and read-only. It remains available for viewing and report export.
• Setting: Displays the Assessment Setting used for the version.
• Description: Displays the description entered during finalization.
• Start Date: Displays the date the assessment started.
• Start User: Displays the user who started the assessment.
• Finalize Date: Displays the date the assessment was finalized.
• Finalize User: Displays the user who finalized the assessment.
• Total Risks: Displays the total number of risks across all CTQs in the assessment version.

Assessment Version Page

The steps below describe the workflow for conducting an assessment, including creating or opening a version, selecting CTQ considerations, adding risks, validating completeness, and finalizing the assessment.

To access the Assessment Version page:

• Click Start Assessment to open a new assessment version.
• Click the hyperlink in the Version column on the Assessment tab to open that specific assessment version.
• The Assessment Version page displays CTQ considerations grouped by CTQ in the left navigation. The workspace displays risk cards for the selected consideration, including score, risk control action, and evaluation details.

Assessment Header

• Back Arrow: Return to the Assessments tab and the Assessment Versions listing.
• Display Pills: Display the current status, total CTQ considerations, and total risks. Counts update automatically.
• View All Risks: Display all risk cards across all CTQ considerations.
• View Incomplete: Filter risk cards with missing required information.
• Documentation: Open the Documentation window to manage version details, protocol changes, and change history.
• Review and Approval: Opens the review and finalization workflow window. Depending on the configured workflow, users can submit the assessment for review, complete review or approval steps, request revisions, or finalize the assessment. When review and approval are not configured, the assessment can be finalized directly.
• Comments & Activities: Open the Comments & Activities panel to capture structured collaboration, including feedback, @mentions, and workflow activity tracking.
• Report: Downloads a read-only Risk Management Plan report, aligned with ICH E6 (R3) guidelines. Export options include Excel and PDF. At least one risk must be added to activate the report icon and enable printing.

Review and Approval Workflow

RACT assessments support an optional review and approval workflow. When configured, assessments move through defined statuses, including In Progress, Pending Review, Pending Approval, Pending Finalization, and Finalized.

Assigned Owners, Reviewers, and Approvers complete workflow actions based on defined responsibilities. The Comments & Activities panel records comments, status changes, and workflow actions to support traceability.

When review and approval are not configured, completed assessments can be finalized directly.

CTQs, Considerations, and Risks

• The left navigation panel shows considerations grouped under the CTQ heading. A gray badge to the right of each consideration indicates the number of assigned risks.
• The CTQ considerations displayed in the left panel are determined by the settings in Risk Management Configuration. Setting the status to Inactive for a CTQ or an individual consideration removes it from the list for all new assessments.
• Users select which CTQ considerations require risks. Even if some considerations have no risks added, the version can still be finalized as long as all required fields for the included risks are complete.
• When an assessment version opens, the right side displays all risk cards for the assessment. Selecting a consideration updates the workspace to display only the associated risk cards.
• A risk card displays for each risk added to a consideration. The card shows the score, Risk Control Action, Contingency Actions, Review Plan (IDRP) indicator, Risk Description, and Risk Evaluation.

• Once all risks are complete (and approved if review and approval workflow is used for the assessment) for the selected CTQ considerations, the assessment can proceed to finalization.

  Note: Finalized assessments are read-only. Risk details remain available for viewing, reporting, and comparison, but cannot be edited.

  Note: For details on conducting and finalizing an assessment, see the article, Manage Risks and Conduct Assessments in the RACT.

Archived

The Archived view lists assessment versions that have been removed from active use.

Archiving moves a finalized version out of the Assessments tab and records the Archive Date, User, and Reason. Archived versions are locked against further edits. Only the summary row remains available for audit reference.

Risk Summary

The Risk Summary view provides a study-wide catalog of all risks created across all assessment versions. This consolidated view supports trend analysis, audit preparation, and verification of risk coverage without opening individual assessments. 

Use the scrollbar to view additional columns.

Export the Risk Management Plan

The exported Risk Management Plan is eTMF-ready and adheres to industry-standard Electronic Trial Master File requirements. The report is also compliant with ICH E6 (R3) guidelines, aligning with regulatory expectations for Good Clinical Practice (GCP). 

The Risk Management Plan can be exported directly from the Assessment Version page, during assessment review or after the assessment has been finalized. The report can be exported as an Excel or a PDF.

1. Click the Report icon on the Assessment Version page. 
2. Select Excel or PDF from the export options.

The report downloads automatically after selection.

Note: Contingency Actions are included in the Risk Management Plan export when configured for risks in the assessment.