Permissions: RACT Assessment Read Only: Provides access to view assessments and export reports.
RACT Assessment Read Write: Provides access to create, edit, archive, and finalize assessments and manage risks. 
Risk Management Configuration: Provides access to 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 support traceability.

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.
• Associate predefined Critical Data, Critical 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.
• Add comments, @mentions, and workflow updates in the Comments & Activities panel.
• 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.
• Use RACT Analytics to review study-level risk performance and evaluate how Risks align with IDRP Review Objectives.

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 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 Open Recent 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.

Navigate RACT

The RACT page opens for the selected study and displays All under Assessments by default. The page lists all active assessment versions for the study, including status, settings, and key details. Select Archived to view archived assessments. Under Analytics, select Overview to review study-level risk analytics or IQRM to review how study Risks align with IDRP Review Objectives.

Note: Listings in the All and Archived views support sorting, filtering, resizing, and fixing columns.

Assessments

The All view under Assessments displays all active assessment versions for the selected study.

Use Page Actions

• Create Reassessment: Creates a reassessment based on a finalized assessment and carries forward its Risks.
• Create New Assessment: Creates an assessment without carrying forward Risks from a finalized assessment.
• Archive: Archives the selected finalized assessment versions. Archived versions cannot be restored.
• Compare: Compares two selected finalized versions side by side.
• Filters: Displays or clears active column filters. The icon displays as solid when filters are applied.

Review Assessment Versions

• Version: Click the version link to open the assessment. An assessment displays as Draft until it is finalized and assigned a version name.
• 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 Assessment Version page supports conducting an assessment, including reviewing CTQ Considerations, adding and managing Risks, validating completeness, and finalizing the assessment.

To access the Assessment Version page:

• Click Create New Assessment from the All view to create an assessment without carrying forward existing Risks.
• Click Create Reassessment from the All view to create a reassessment based on a finalized assessment and carry forward its Risks.
• Click the link in the Version column in the All view to open an existing assessment version.

The Assessment Version page displays CTQ Considerations grouped by CTQ in the left navigation. The right side displays Risk cards for the selected Consideration, including score, Risk Control Action, and evaluation details.

Assessment Header

• Back Arrow: Returns to the Assessment Versions listing in the All view.
• Status and count badges: Display the current status, total CTQ Considerations, and total Risks. Counts update automatically.
• View All Risks: Displays all Risk cards across all CTQ Considerations.
• View Incomplete: Filters Risk cards with missing required information.
• Documentation: Opens 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, the assessment can be submitted for review, completed through required review or approval steps, returned for revisions, or finalized. 
• Comments & Activities: Opens the Comments & Activities panel for comments, @mentions, and workflow activity tracking.
• Report: Opens export options for the read-only Risk Management Plan, aligned with ICH E6 (R3) guidelines. Select Export as Excel or Export as PDF to export the report. At least one Risk must be added to activate the Report icon and enable export.

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, the assessment can be finalized directly.

CTQs, Considerations, and Risks

• The left navigation panel shows Considerations grouped under each CTQ. A gray badge next to each Consideration indicates the number of assigned Risks.
• Configured CTQs and Considerations displayed in the left navigation are determined by the settings in Risk Management Configuration. Setting the status to Inactive for a configured CTQ or Consideration removes it from the list for all new assessments.
• The system-defined Study Specific and Unaffiliated CTQs provide standardized locations for study-specific Risks and Risks that do not align with an existing CTQ. These CTQs and their Considerations support Risk creation, the Move Risk action, and export. Because these CTQs are system-defined, they cannot be modified. Existing finalized assessments are not affected.
• Select the CTQ Considerations that require Risks. An assessment can be finalized when all required fields for included Risks are complete, even when some selected Considerations have no Risks.
• When an assessment version opens, the right side displays all Risk cards for the assessment. Selecting a Consideration updates the right side 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.
• When all Risks are complete and required review and approval steps are complete, the assessment can proceed to finalization.

Note: For Risks carried forward from a finalized assessment, the Risk Description and Risk Statement fields are read-only. For Library-linked Risks, the Risk Description field remains read-only until the Risk is unlinked from the Library.

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 assessment version from the All view to the Archived view and records the Archive Date, User, and Reason. Archived versions are locked against further edits. Only the summary row remains available for audit reference.

Analytics

The Analytics section provides study-level risk analytics and integrated quality risk management information.

Overview

The Overview page provides a study-level view of Risks across finalized assessments. Summary cards display information about Risks, Functional Plans, Metrics, and Mitigations. Interactive charts display Risk Score (RPN) Over Time, Risk Distribution, KRI Distribution, Mitigation by Risk, and Risk Distribution by Functional Plan.

Use the Assessments, CTQs, and Risk Control Actions filters to update the dashboard. The Risk Summary table at the bottom of the page provides supporting Risk details.

IQRM

The IQRM page displays how study Risks from the latest finalized assessment align with IDRP Review Objectives. The page includes summary metrics, visualizations, and the Integrated Quality Risk Management Plan (IQRMP) table.

Use the CTQ and Risk Control Action filters to update the dashboard. The IQRMP table supports sorting, filtering, and export to Excel or PDF.

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 from the Assessment Version page during assessment review or after the assessment is finalized. Export options include Export as Excel and Export as PDF.

1. Click the Report icon on the Assessment Version page. 
2. Select Export as Excel or Export as PDF.

The report downloads automatically.

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