Permissions: RACT Assessment Read Only: View assessments and exports. 
RACT Assessment Read Write: Create, edit, archive, and finalize assessments and risks.
Risk Management Configuration: Add new supported multi-select options during an assessment.

Assessments are conducted using the most recent Risk Management Configuration. The CTQs, Considerations, Critical Data, Critical Processes, KRIs, QTLs, Functional Plans, and Risk Libraries made available and used in the assessment are defined within this configuration. (Refer to the Risk Management Configuration article in the Risk Management section for details.)

Tip: At the bottom of the left navigation panel, there are links to the Risk Management and RBQM modules. This allows users to navigate seamlessly between Risk Management, RACT, and RBQM.

Create an Assessment

To start a new RACT Assessment, click the Create Assessment button on the Assessments page. The Create New Assessment window opens.

Configure Assessment Team

Participants can be added during assessment creation to define roles in the review and approval workflow.

Assessment team members define roles in the assessment workflow. The Owner is a required role and must also be assigned as a Participant. At least one Participant and one Owner must be assigned, or the assessment cannot be created and a validation message displays.

Reviewers and Approvers are optional and do not need to be Participants.

The Owner can finalize the assessment directly once all risks are completed. If Reviewers or Approvers are assigned, the assessment must progress through the review and approval workflow before finalization.

The assessment team can also be updated from the Review and Approval panel after the assessment is created. All users can view the panel, but only Owners can add users, assign roles, or update the assessment team. At least one Owner must remain assigned.

Enter the participant name and select the applicable function and roles.

1. Click Add to include the participant.
   • User: Select the user from the drop-down.
   • Function: Enter the function.
     Assigned roles determine responsibilities during the review and approval workflow.
   • Select one or more roles as needed:
     • Participant
     • Owner
     • Reviewer
     • Approver
2. Use the Delete option to remove a participant if needed.

Note: If the review and approval workflow is not configured, assigned roles do not impact finalization.

Select Assessment Setting

1. Select the Assessment Setting for this assessment version. The Assessment Setting determines the CTQs and considerations, risk assessment form fields, and the risk level scoring.
2. Click Create. A draft assessment with a status of In Progress opens. The assessment version name is assigned once the assessment is finalized. 

To open an existing draft or a finalized assessment version, click the hyperlink in the Version column in the Assessment Versions listing. 

Note: If a draft assessment already exists for the study, starting a new assessment prompts a warning that the existing draft will be overwritten and any unsaved progress will be lost.

Note: Risks are carried over to a new assessment version only when the same Assessment Setting is used as the previous finalized assessment. If a different Assessment Setting is selected, risks are not carried over.

Define Assessment Version

The Assessment Version page displays CTQ Considerations grouped by CTQ in the left panel and all risk cards for the version in the workspace. Selecting a consideration updates the workspace to display only the associated risks. The gray badge indicates the number of risks for each consideration.

1. Select a CTQ Consideration from the left panel. Participants determine which considerations are applicable to the assessment and assign the corresponding risks. Considerations that are not applicable may be skipped. The assessment can be finalized even if some considerations do not have Risks, provided all required fields for the included Risks are complete.

   Note: General Risk(s) is automatically added as the last consideration under each CTQ to capture risks not linked to a specific consideration.

   Tip: Click the Details icon next to the CTQ header in the left panel to view the details of all considerations for that CTQ in the workspace to the right.

Add a Risk

1. Select a consideration in the left panel. The selected consideration displays at the top of the workspace. Click Add Risk to open the Add Risk window. Multiple risks can be added to the same consideration.

   

2. The Add Risk window opens.
   

Note: Fields with a red asterisk are required. Use the scrollbar to view all fields.

Note: Users with Risk Management Configuration privileges can add new options directly from supported multi-select fields. Enter a value that does not exist, then click + Add to create and select the entry. Newly created entries are available for reuse across studies.

Add a Risk Manually

Enter the required fields in the Add Risk window to define and evaluate the risk.

• Risk Assessment ID: Auto-populated and uniquely identifies the risk within the assessment.
• Complete all required fields based on the configured Risk Assessment form.

Click Save to add the risk to the assessment.

Add a Risk from the Risk Library

Use the Risk Library to quickly add preconfigured risks and standardize risk definitions.

Click Select Risk from Library to open the Select Risk window.

• Use the Search field to locate a risk.
• Select a risk from the list.
• Click Apply.

Risks related to similar CTQs are prioritized.

The selected risk populates fields in the Add Risk window, including:

• Risk description and classification
• Mitigation actions
• Monitoring metrics

A reference table displays in the Risk window and remains visible when reopening the Risk unless removed. This provides traceability to the source library entry.

Scroll further to view all fields, including recommended Monitoring Metrics.

Review and Update Populated Fields

Review all populated values to ensure they align with the study context.

Fields populated from the Risk Library may include:

• Functional Plan
• Pre-Study Mitigation Actions
• During-Study Mitigation Actions
• Contingency Actions

Metric recommendations, including KRIs and QTLs, are also provided. Select or adjust values as needed.

Complete any remaining required fields before saving.

Generate an AI Risk Statement

Use AI-assisted generation to create a structured Risk Statement based on the Risk Description.

Click Generate Statement.

The system:

• Parses the Risk Description
• Populates:
  • Event
  • Cause
  • Impact
• Generates a structured if / due to / then statement

Additional behavior:

• Click again to generate alternative suggestions.
• Updates rerun automatically when the Risk Description changes.
• All AI-generated actions are logged for auditing.

Note: AI-assisted generation requires Allow Machine Learning to be enabled. The quality of AI-generated content depends on the clarity and completeness of the Risk Description. Review and edit as needed.

Note: AI-generated content includes a disclaimer to indicate that the content requires review. After a user edits the content, the system considers it reviewed and removes the disclaimer.

Critical Data and Processes

Identify the critical data and processes impacted by the risk to support risk evaluation and monitoring.

• Critical Data: Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse.
• Critical Processes: Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse.

Risk Evaluation

Define how the risk is assessed by assigning scores that determine its overall impact and priority.

• Impact: Select the severity of the risk.
• Likelihood: Select the probability of occurrence.
• Detectability: Select how easily the Risk can be detected.

These values are defined in Risk Management Configuration > Risk Levels.

• Weight: Adjust to scale the overall score if needed.
• Risk Control Threshold: Displays the threshold that triggers mitigation.
• Overall Risk Score (RPN): Automatically calculated as Impact × Likelihood × Detectability × Weight.
• Weight Change Justification: Enter justification if the default weight is modified.

Risk Control and Functional Plans

Define how the risk will be managed and who is responsible.

• Risk Control Action: Select Accept or Mitigate.
• Risk Owner: Enter the responsible individual.
• Risk Owner Role: Enter the associated role.
• Detectable via ongoing monitoring: Indicate if monitoring applies.
• Functional Plan: Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse. Select the plan that governs control activities for the relevant function.

• Available plans are maintained in Risk Management Configuration > Functional Plans.

Monitoring Metrics

Define how the risk will be monitored during the study.

• Quality Tolerance Limits (QTLs): Select or add thresholds that measure study-level quality performance.
• Key Risk Indicators (KRIs): Select or add metrics used to monitor ongoing risk.

Click Add to include multiple metrics as needed.

• Include into Review Plan: Select Yes to make the risk available for linking to Review Objectives in Data Central.

Risk Control Actions

Define mitigation actions for the risk.

• Pre-Study Mitigation Actions: Define actions performed before study start. Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse.
• During-Study Mitigation Actions: Define actions performed during study execution. Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse.

Contingency Actions

Define actions to be taken if the risk is realized despite mitigation efforts.

• Contingency Actions: Enter contingency actions to support response planning if the risk occurs. Select from the multi-select drop-down, or enter a new value and click Add. Newly created entries are available for reuse.

If the risk is selected from the Risk Library, configured Contingency Actions automatically populate and can be reviewed, removed, or updated as needed.

Note: The Contingency Actions field is configurable and may not display if it is not enabled in Risk Management Configuration.

Risk Review and More Details

Capture outcomes if the risk occurs and document follow-up actions.

• Risk Realized: Indicate if the risk occurred (Yes/No).
• Date Risk Realized: Enter the date.
• Realization Comments: Document outcomes, root causes, or related Risk Signals or Issues.

This section supports audit readiness and traceability.

Save the Risk

Click Save.

The system assigns a Risk Assessment ID, and the risk displays in the assessment.

Note: The Risk Assessment ID is assigned at the study level and differs from the Risk ID defined in the Risk Library.

Edit a Risk

Use the Edit Risk window to update risk details, mitigation actions, monitoring metrics, and evaluation fields throughout the assessment lifecycle.

Click a risk card, or click the Comments icon on a card to open the Edit Risk window with the Comments panel open.

Update the fields as needed, then click Save to apply changes.

The Risk Assessment ID is system-generated and cannot be edited, ensuring auditability and traceability.

Note: In finalized assessments, the Edit Risk window is read-only and cannot be modified.

Delete a Risk

1. Click the Delete icon on the risk card. The confirmation prompt opens.

2. Select Delete to remove the risk, or select Cancel to keep the risk.

Note: Risks in finalized assessments cannot be deleted.

Conduct an Assessment

Conduct an assessment by reviewing CTQ Considerations, adding or updating risks, resolving incomplete risk cards, and using comments to support collaboration.

• View Incomplete: Click to display risk cards with missing required fields. Complete all required fields before submitting, approving, or finalizing the assessment.
• Documentation: Open the Documentation window to enter version details, protocol changes, and change history at any time during the assessment lifecycle.
• Comments & Activities: Add assessment-level comments, use @mentions, and review activity history. Mentioned users receive email notifications.
• Risk comments: Click the Comments icon on a risk card to add comments specific to that risk.

Review and Approval Workflow

RACT assessments support an optional review and approval workflow. The workflow depends on the roles assigned to the assessment team.

If only Owners and Participants are assigned, the assessment does not require review or approval. The Owner can finalize the assessment after all required fields are complete.

If one or more Reviewers are assigned, the assessment must move through Pending Review before finalization. All assigned Reviewers must complete their review before the assessment can continue.

If one or more Approvers are assigned, the assessment must move through Pending Approval before finalization. All assigned Approvers must complete their approval before the assessment can continue.

If both Reviewers and Approvers are assigned, the assessment moves through the full workflow:

• In Progress: Assessment activities and updates are in progress.
• Pending Review: Assigned Reviewers complete their review.
• Pending Approval: Assigned Approvers complete their approval.
• Pending Finalization: The assessment is ready for the Owner to finalize.
• Finalized: The assessment is locked and read-only.

Owners submit assessments for review and finalize assessments at the Pending Finalization stage. Owners can also withdraw a submission, which resets the workflow progress.

Reviewers and Approvers can complete their assigned step or request revisions. Withdrawing an individual review or approval affects only that user’s progress and does not change the overall assessment status.

The assessment advances to the next workflow status only after all assigned users for the current stage complete their required action.

As the assessment progresses through each stage, assigned users receive email notifications with a link to the assessment, allowing them to access and complete their assigned actions.

Check Review Status

After an assessment is submitted for review, the value in the Status column becomes a hyperlink. Click the status to open the Review Status window and view progress across Reviewers and Approvers.

The Review Status window displays each assigned user and their current workflow status.

Comments & Activities

Comments support collaboration and traceability throughout the assessment lifecycle.

• Comments can be added at the assessment level or risk level.
• Assessment-level comments apply to the full assessment.
• Risk-level comments apply to an individual risk.
• Use @mentions to notify another elluminate user. Mentioned users receive an email notification.
  • Only users with access to the assessment can be tagged or mentioned in comments.
• All status updates, such as In Progress to Pending Review, are reflected as activities in this side panel.

Comments and activity history remain available after finalization.

Add or Review Comments

Click the Comments & Activities button. The panel opens.

Click Close to close the panel.

Document, Review, and Finalize an Assessment

Documentation

The Documentation window supports structured assessment documentation throughout the lifecycle, including version details, protocol changes, and change history.

Click Documentation. The Documentation window opens.

1. Update the fields:
   Scroll to access all fields.

• Version Description: Enter description.
• Protocol Amendment: Enter the protocol amendment.
• Protocol Amendment Date: Enter the date or use the calendar picker.
• Protocol Complexity: Enter protocol complexity.

Version History

• Description of the Change: Enter a description.
• Reason for the Change: Enter the reason.

Reassessment Interval

• Select Week or Day.
• Enter the number of weeks or days.

2. Click Save.

Review and Approval

The Review and Approval workflow manages submission, review, approval, revision requests, and finalization.

1. Click Review and Approval. The window opens.

2. Update the Assessment Team if needed.
   Note: The review and approval workflow is optional and depends on the roles assigned to the assessment team. If no users are assigned as Reviewer or Approver, the Owner can finalize the assessment directly.
3. Click Save to apply changes.

Submit for Review

The Owner submits the assessment to begin the review process.

1. Click Submit for Review.
2. Click Continue to confirm.

Reviewers and Approvers receive an email with a link to the assessment.

Complete Review

Users assigned as Reviewers complete their review of the assessment.

1. Open the assessment from the email link.
2. Review the assessment.
3. Select Request Revision or Complete Review.

The assessment advances automatically when all reviewers complete their review.

Request Revision

Reviewers or Approvers can request updates before the assessment proceeds.

1. Enter a comment (owners are automatically @mentioned).
2. Click Submit.
3. Mentioned users receive an email notification.

Withdraw Review

Reviewers can withdraw their review to update their response.

1. Click Withdraw Review.
2. Click Continue.

This resets only the user’s review status and does not change the overall assessment status.

Approve

Approvers complete their approval step for the assessment.

1. Click Approve.
2. Click Continue in the Attention window.

Finalize

The Owner finalizes the assessment after all required workflow steps are complete.

1. Click Finalize. The Finalize Assessment window opens.

2. Update the fields:
   Scroll to access all fields.

• Version Name: Enter a name.
• Version Description: Enter description.
• Protocol Amendment: Enter the protocol amendment.
• Protocol Amendment Date: Enter the date or use the calendar picker.
• Protocol Complexity: Enter protocol complexity.

Version History

• Description of the Change: Enter a description.
• Reason for the Change: Enter the reason.

Reassessment Interval

• Select Week or Day.
• Enter the number of weeks or days.
• Select Create a new version of the assessment with the same settings, if needed.

3. Click Finalize.

Integrated Data Review Plan & Risks

RACT integrates with the Integrated Data Review Plan (IDRP) to align identified risks with Review Objectives defined in Data Central.

• Link Risks to Review Plan: When adding or editing a risk during an assessment, set Include into Review Plan to Yes to make the risk available for selection in Review Objectives in Data Central configuration. A risk is linked to the Review Plan only after it is selected in one or more Review Objectives. Linkage is based on the latest finalized assessment.
• Review Plan Indicator: For finalized assessments, risks that are linked to the Review Plan display a Review Plan (n) indicator on the risk card in the upper right corner, where n is the number of linked Review Objectives.

• Hover Behavior: Hover over the Review Plan Indicator to view a table tooltip that lists linked Review Objectives, including identifier, version, description, and approval status. If no Review Objectives are linked, the tooltip states that none are associated.

  
   

• Click Behavior: Click the Review Plan indicator to open the Review Plan in Data Central Configuration, filtered to the selected risk.

  

Archive an Assessment

Assessments cannot be deleted for compliance reasons. Only finalized assessments can be archived. Archived assessments are removed from active use and cannot be recovered.

1. From the RACT Assessment page, select a finalized assessment version to archive, then click Archive. The Archive Assessment window opens.

   

2. Review the Risk Assessment Version Details and enter the Reason for Archive.

   

   Note: If the latest finalized assessment contains risks that are linked to Review Objectives, a warning message is displayed before archiving. Archiving the assessment breaks the linkage to the Review Plan, but users can still view the linked Review Objectives before proceeding.

3. Click Archive Assessment. The assessment version is permanently archived, removed from active listings, and moved to the Archived page for reference.

Toolbar Icons & Actions

Icon	Icon Name	Description
	9-dot	Opens the Platform Menu.
	elluminate Logomark	Returns to the Home Page.
	Configuration	View or edit study configuration.
	Help	Opens the Help menu (Help Center, Community, Learning Portal, Support Information, Privacy Policy, Legal Notices, and elluminate Version).
	Blue Badge	Displays the number of items listed on the page.
	Filters	Use to clear filters. If highlighted, it indicates filters are applied to the page.
	RBQM	Navigates to the RBQM Overview dashboards.
	Risk Management	Navigates to the Risk Management home page.
	Back	Returns to the RACT Assessment page.
	Report	Exports the eTMF-ready Risk Management Study report to Excel or PDF.
	Search	As text is entered, matching items display in the list.
	Delete	Deletes an item.
	Details	Opens the Details view for the selected CTQ in the left navigation, displaying all considerations and associated risks in the workspace.
	Not Answered	In the left navigation, indicates that no risks have been added for the consideration.
	Work in Progress	In the left navigation, indicates that one or more risks have been started but required fields are incomplete.
	Completed	In the left navigation, indicates that all risks for the consideration are complete and all required fields are populated.
	Gray Badge	In the left navigation, indicates the number of risks started and / or completed for the consideration.