
GITNUXSOFTWARE ADVICE
Biotechnology PharmaceuticalsTop 10 Best Clinical Trial Randomization Software of 2026
Ranked review of the top clinical trial randomization software options, including Signant Health IRT and Castor EDC, for CRO selection.
How we ranked these tools
An editor sets the topic, the inclusion criteria, and the evaluation framework before research starts.
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Framework: Features 40% · Ease 30% · Value 30%
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Castor EDC is the best fit when your trial team wants randomization tightly linked to enrollment and dispensing operations, while Signant Health IRT is the better choice if centralized allocation, kit assignment, and unblinding need disciplined, controlled execution across sites.
Editor’s top 3 picks
Three quick recommendations before you dive into the full comparison below — each one leads on a different dimension.
Castor EDC
Operational audit trail for randomization actions tied to study configuration and treatment code handling.
Best for: Fits when trial teams want randomization tied tightly to enrollment and dispensing operations.
Signant Health IRT
Editor pickEmergency unblinding and treatment code handling are managed within the same operational allocation workflow.
Best for: Fits when centralized allocation, kit assignment, and unblinding workflows must stay tightly controlled across many sites.
OpenClinica
Editor pickStudy-level randomization configuration keeps assignment outcomes linked to EDC-style study events and audit tracking.
Best for: Fits when randomization must stay synchronized with EDC-driven enrollment and operational states across sites.
Comparison Table
Castor EDC
SMBCastor EDC provides clinical data capture with study randomization features for research teams.
Operational audit trail for randomization actions tied to study configuration and treatment code handling.
Castor EDC treats randomization as a workflow tied to study configuration, not a standalone scheduler. Study teams can define allocation logic, configure assignment rules, and manage treatment code generation and reconciliation through the same clinical trial environment used for enrollment and data capture.
A key tradeoff is that deeper automation and system integration breadth depends on the specific integration pattern selected for the trial stack. Castor EDC fits well when a single study team needs controlled randomization execution that stays synchronized with enrollment status and investigational product dispensing steps.
- +Study configuration and randomization execution stay synchronized in one workflow
- +Treatment code and assignment handling follows controlled operational steps
- +Audit trail coverage supports review of randomization decisions and outcomes
- +Governance-focused administration helps limit configuration errors
- –Advanced automation patterns require more integration work in complex trial stacks
- –Some operational controls depend on how study teams map statuses and eligibility
Trial operations leads
Run interactive randomization with controlled steps
Fewer status mismatches during assignment
Biostatisticians
Set allocation logic for study execution
Consistent allocation across sites
Show 1 more scenario
Clinical data managers
Reconcile treatment codes post-enrollment
Faster discrepancy triage
Managers trace randomization actions and assignment outcomes against captured data for review.
Best for: Fits when trial teams want randomization tied tightly to enrollment and dispensing operations.
Signant Health IRT
vertical specialistSignant Health IRT supports participant randomization, trial supply management, and study logistics.
Emergency unblinding and treatment code handling are managed within the same operational allocation workflow.
Signant Health IRT fits trial programs that need consistent treatment-arm allocation across many sites while still enforcing enrollment rules and eligibility-based assignment. Administration emphasizes configuration-driven study setup, plus operational tooling for daily randomization, resupply, and emergency unblinding workflows. The automation surface is geared toward reducing manual rekeying between the randomization event and kit or shipment tracking.
A key tradeoff is that deeper automation and governance usually increases upfront configuration work for stratification factors, caps, and protocol-specific cohorts. The strongest fit shows up in multi-site trials with site-level activation and frequent operational events like screen failures, kit reassignments, and controlled unblinding procedures.
- +Centralized treatment code workflows reduce cross-site allocation inconsistencies
- +Cohort-aware handling supports multi-group enrollment patterns
- +Emergency unblinding workflow is operationally integrated with code management
- +Study configuration supports stratification logic and enrollment constraints
- –Setup effort rises with complex stratification and cohort configuration
- –Some integrations require deeper study-operations alignment than expected
- –Workflow tuning can lag behind rapidly changing protocol amendments
- –Reporting breadth depends on how trial systems are connected
Clinical operations teams
Daily randomization with controlled enrollment
Fewer allocation and kit mismatches
Data management leads
Propagate randomization into EDC
Reduced manual data correction
Show 1 more scenario
Protocol managers
Cohort and amendment handling
Lower protocol amendment friction
Supports cohort configuration so enrollment rules stay aligned with protocol structure.
Best for: Fits when centralized allocation, kit assignment, and unblinding workflows must stay tightly controlled across many sites.
OpenClinica
SMBOpenClinica provides electronic data capture and clinical study workflows that can support participant randomization.
Study-level randomization configuration keeps assignment outcomes linked to EDC-style study events and audit tracking.
OpenClinica is designed for study teams that treat randomization as part of the clinical trial lifecycle. Randomization configuration covers arm definitions, allocation structures, and rule-driven assignment logic so the assignment outcome can be tied to study records. Operationally, assignment activity is tracked with an audit trail that aligns with regulated documentation needs. Integration depth tends to matter most when EDC events, enrollment eligibility decisions, and randomization timing must stay consistent.
A practical tradeoff is that deeper integration usually increases upfront study configuration effort compared with minimal randomization-only tools. OpenClinica works well when a sponsor or CRO runs centralized randomization and needs consistent behavior across sites while still reflecting site and subject operational states. It is also a strong fit for studies that require treatment code handling to remain synchronized with the systems that record eligibility, enrollment, and dispensability events.
- +Randomization actions tie back to core study records and status
- +Audit trail covers assignment-relevant study changes
- +Configuration supports stratification-driven and schedule-based assignment logic
- +Centralized trial workflows can stay consistent across sites
- –Setup effort can be higher when randomization must mirror EDC workflows
- –Advanced customization can require deeper knowledge of study configuration
Sponsors running centralized trials
Central randomization across many sites
Fewer assignment reconciliation steps
CRO trial operations teams
Consistent enrollment to assignment
Lower operational variance
Show 2 more scenarios
Data managers and statisticians
Stratified assignment logic control
Predictable allocation behavior
Stratification and allocation settings can be governed at study configuration time.
Regulated compliance stakeholders
Assignment audit traceability
Clearer audit documentation
Assignment-related study changes can be documented through system audit records.
Best for: Fits when randomization must stay synchronized with EDC-driven enrollment and operational states across sites.
Oracle Clinical One Randomization and Trial Supply Management
enterpriseOracle Clinical One supports randomization, enrollment, drug supply, and treatment assignment management.
End-to-end treatment code management that coordinates randomization schedules with investigational product kit and dispensing execution.
Oracle Clinical One Randomization and Trial Supply Management ties randomized treatment assignment to investigational product supply processes inside the Oracle clinical ecosystem. It supports centralized treatment code management and operational controls for kit assignment, dispense workflows, and schedule handling across multi-site studies.
The automation surface centers on provisioning of randomization schedules and the controlled generation of treatment codes that feed kit and dispensing execution. Governance emphasis shows up through audit trail coverage and administrative separation for enrollment, allocation, and dispensing activities.
- +Tight alignment between treatment code generation and kit assignment workflows
- +Centralized control supports treatment allocation across many sites
- +Audit trail support helps track allocation and dispensing actions
- +Configuration-driven setup supports study-specific randomization schedules
- –Requires strong study provisioning discipline to avoid operational mismatches
- –Admin workflows can feel heavier than lighter standalone RTSM tools
- –Advanced allocation scenarios may depend on Oracle clinical configuration depth
- –Integration work is more involved when EDC and IVR targets differ from Oracle patterns
Best for: Fits when large organizations need centralized allocation and supply execution under Oracle governance.
4G Clinical Prancer
vertical specialistPrancer automates clinical trial randomization and supply management through an IRT platform.
Treatment code management workflow that coordinates assignment records for drug dispensing operations and controlled access.
4G Clinical Prancer generates randomization schedules and manages treatment code handling for clinical trials. Its core workflow centers on building allocation logic, assigning subjects to arms or treatments, and supporting site-level dispensing operations with controlled code access.
Administration focuses on configured randomization parameters, enrollment and cohort tracking, and audit-friendly activity logging. Integration is oriented around interactive trial communication needs tied to the randomization and drug assignment lifecycle.
- +Supports end-to-end randomization to treatment code lifecycle within one workflow
- –Limited documented automation surface for EDC-linked orchestration compared with top RTSM competitors
Best for: Fits when mid-size trials need controlled allocation configuration and treatment code management with disciplined governance.
Clario IRT
enterpriseClario IRT supports randomization and supply management within a clinical trial technology portfolio.
Study configuration links allocation rules to treatment code or kit dispensing flows through interactive response endpoints.
Clario IRT is a clinical trial randomization and drug-dispensing system built around an allocation workflow that connects treatment assignment to kit or treatment code handling. It supports sponsor-level governance for treatment-arm allocation rules, enrollment controls, and randomization schedule management while coordinating site-facing assignment through interactive endpoints.
Integration coverage centers on EDC connectivity patterns and interactive response technology, so treatment codes and randomization outcomes can propagate to dispensing and operational systems. Administrative control focuses on configuration-driven study setup, audit trail visibility, and role-based access patterns for trial operations.
- +Configuration-driven study setup reduces custom development for allocation and dispensing rules
- +Interactive response workflow supports site assignment and treatment code propagation
- +Audit trail visibility supports operational traceability for assignment and dispensing actions
- +Strong sponsor governance for enrollment controls and treatment-arm assignment constraints
- –Setup complexity increases when multiple stratification factors and enrollment caps are used
- –Integration effort can be significant when mapping EDC events to randomization outcomes
- –Governance controls require careful role design across sponsor and site staff
- –Emergency workflow coverage depends on study configuration choices and operational readiness
Best for: Fits when sponsors need centralized randomization governance with site-facing assignment and auditable dispensing workflows.
Endpoint Clinical PULSE
vertical specialistPULSE supports randomization, drug supply management, and patient enrollment for clinical trials.
Centralized treatment code management with controlled emergency unblinding and allocation-linked audit trails.
Endpoint Clinical PULSE targets clinical trial randomization workflows with configurable allocation logic, kit assignment support, and centralized treatment code handling. The system emphasizes governance controls such as audit trails, role-based access, and emergency unblinding pathways for operational continuity.
It is most useful when randomization must integrate tightly with clinical data and trial operations systems, especially across study and site boundaries. Automation coverage centers on provisioning, allocation execution, and ongoing reconciliation between enrolled subjects and assigned treatment codes.
- +Governance controls include audit trail visibility across allocation and code changes
- +Emergency unblinding workflow supports controlled access during urgent scenarios
- +Configuration supports study-level randomization rules and enrollment-driven allocation
- +Treatment code management supports kit assignment and dispensing readiness
- –Admin setup requires careful configuration of allocation rules and eligibility inputs
- –Advanced optimization approaches may require specialist configuration support
- –API surface is not the strongest area compared with more developer-first tools
- –Some workflow depth depends on tight integration with downstream operational systems
Best for: Fits when trial teams need controlled treatment code governance and allocation execution with auditability across sites.
REDCap
SMBREDCap is a research data platform with a randomization module for eligible institutional deployments.
Allocation outputs generated through REDCap’s interactive randomization flow are persisted alongside eCRF data.
REDCap is a clinical data capture system that can function as a randomization and allocation-concealment workflow when configured with an interactive randomization feature. It supports rules-driven assignment across study records, and it stores allocation decisions inside the same project data model used for case report forms.
REDCap also provides an automation layer for scripted events, plus an integration surface for exchanging study and enrollment data with external systems. For clinical trial randomization, the main distinction is that REDCap keeps randomization outputs and trial data under one governance and audit trail structure instead of splitting them across an RTSM-only workflow.
- +Randomization outcomes are stored in the same project records as trial data
- +Event-driven automation can trigger assignment and downstream data collection
- +Fine-grained role permissions support controlled access to allocation-related fields
- +Audit trail records changes to study data linked to enrollment and allocation
- –Interactive randomization support can require careful configuration for complex designs
- –High-throughput multi-site allocation may need external orchestration for performance
- –API-based integration requires add-on planning for exchanging allocation state reliably
- –Stratified and dynamic allocation use is limited compared with dedicated RTSM
Best for: Fits when trial teams want allocation decisions and case data governed in one REDCap workspace.
Perceptive MyIRT
enterpriseCloud-based interactive response technology for subject randomization and drug supply.
Emergency access and treatment-code handling are designed to preserve audit traceability during unblinding events.
Perceptive MyIRT performs centralized treatment-arm allocation by generating and managing randomization schedules used for kit assignment and treatment code handling. It supports interactive response workflows for site enrollment and assignment, including controlled release of allocation and emergency access paths.
Configuration is built around study setup artifacts such as stratification factors, enrollment caps, and randomization parameters, with trial and site governance managed through role-based access and audit logging. Integration depth is focused on connecting interactive response operations to surrounding clinical systems for screening, enrollment status, and investigational product dispensing control.
- +Centralized interactive response flow supports allocation release tied to enrollment status
- +Audit trail coverage supports traceability for treatment code and assignment events
- +Study configuration supports stratification factors and enrollment caps for controlled allocation
- +Role-based access supports separation between setup, site actions, and operational oversight
- –Study setup requires careful parameter configuration to avoid allocation rule mismatches
- –Automation depth for complex adaptive designs depends on integration with external trial logic
- –API and extensibility breadth is narrower than some peers focused on broad platform integration
- –Operational admin workflows can feel heavy during high-frequency cohort and schedule changes
Best for: Fits when sponsor teams need tightly governed IRT operations with audit traceability across randomization and dispensing workflows.
Almac IXRS
enterpriseInteractive voice and web response system for randomization and clinical supply chain management.
Integrated emergency unblinding tied to treatment code governance and audit trail events for investigator and sponsor visibility.
Almac IXRS centers on interactive response technology workflows for clinical trial randomization and treatment code management, with controls designed for sponsor and vendor operations. The system supports site-level and central allocation execution, including kit assignment and investigational product dispensing workflows tied to treatment codes.
Almac IXRS also focuses on operational governance through audit trail capture and role-based access patterns used during enrollment, changes, and emergency unblinding. Integration breadth is oriented around trial systems that need randomization schedule exchange and code-list synchronization to electronic data capture and trial management environments.
- +Operational controls support treatment code governance across enrollment states
- +Audit trail coverage supports traceability for allocation and dispensing events
- +Site workflows map to kit assignment and investigational product dispatch needs
- +Emergency unblinding processes support controlled release of treatment assignment
- –Complex protocol setup can require disciplined configuration and signoff cycles
- –Automation depth can lag EDC-native orchestration without tighter integration work
- –API surface details can limit extensibility for niche randomization engines
- –Change management for randomization schedules can add coordination overhead
Best for: Fits when sponsors need controlled IXRS operations with strong auditability across sites and dispensing workflows.
Conclusion
After evaluating 10 clinical trial randomization software, Castor EDC stands out as our overall top pick — it scored highest across our combined criteria of features, ease of use, and value, which is why it sits at #1 in the rankings above.
Use the comparison table and detailed reviews above to validate the fit against your own requirements before committing to a tool.
How to Choose the Right Clinical Trial Randomization Software
Clinical trial randomization software coordinates allocation rules, treatment code handling, and site-facing assignment workflows so enrollment and dispensing stay aligned under controlled governance. This buyer’s guide covers Castor EDC, Signant Health IRT, OpenClinica, Oracle Clinical One Randomization and Trial Supply Management, 4G Clinical Prancer, Clario IRT, Endpoint Clinical PULSE, REDCap, Perceptive MyIRT, and Almac IXRS.
Each tool review below focuses on integration depth, the operational data model used for allocation and code workflows, and the automation and API surface that connects randomization to enrollment and investigational product dispensing. The evaluation also accounts for admin and governance controls such as audit trail visibility across allocation actions and emergency access handling during unblinding.
Clinical Trial Randomization Software for allocation rules, treatment-code governance, and allocation execution
Clinical trial randomization software implements allocation logic for trials that need controlled allocation concealment, cohort-aware assignment, and consistent treatment-arm delivery across sites. It typically ties randomization outcomes to enrollment and dispensing operational states so assignment actions and treatment code handling remain synchronized.
Castor EDC emphasizes operational audit trail coverage that links randomization actions to study configuration and treatment code handling. Signant Health IRT and Endpoint Clinical PULSE both center emergency unblinding and treatment code workflows so release and audit behavior stays tightly controlled across allocation and code changes.
Core capabilities that determine randomization correctness and audit readiness
Clinical trial randomization software must generate assignment outcomes and persist treatment code decisions in a way that stays consistent across enrollment, kit assignment, and investigational product dispensing. The most consequential differences show up in how each tool ties randomization actions to study configuration and operational event states, and how that behavior is governed during emergency unblinding.
Operational audit trail tied to study configuration and treatment code handling
Castor EDC keeps randomization actions synchronized with study configuration and treatment code handling inside a single operational workflow. This reduces audit gaps when assignment decisions must be traced back to the exact configuration and code-handling steps used.
Emergency unblinding workflow integrated with treatment code release
Signant Health IRT manages emergency unblinding and treatment code handling within the same centralized allocation workflow. Endpoint Clinical PULSE and Almac IXRS also provide emergency-access paths that are tied to allocation-linked audit trail behavior.
Tight synchronization between randomization outcomes and EDC-style enrollment events
OpenClinica links study-level randomization configuration to EDC-style study events so assignment outcomes tie back to core study records and status. Castor EDC similarly keeps assignment and treatment code steps aligned with enrollment and dispensing operational states.
Treatment code management coordinated with kit assignment and dispensing execution
Oracle Clinical One Randomization and Trial Supply Management coordinates randomization schedules with investigational product kit and dispensing execution through end-to-end treatment code management. 4G Clinical Prancer also manages the treatment code lifecycle for drug dispensing operations with controlled access patterns.
Configuration-driven allocation rules connected to interactive response endpoints
Clario IRT links study configuration to allocation rules and treatment code or kit dispensing flows through interactive response endpoints. This configuration-driven approach is intended to reduce custom development when site-facing assignment and code propagation must follow auditable dispensing workflows.
Interactive randomization outputs stored with case data in the same workspace
REDCap generates allocation outputs through its interactive randomization flow and persists them alongside eCRF data in the same project records. Event-driven automation can trigger assignment and downstream data collection, which is useful when governance is enforced within a single workspace.
A decision path for selecting the right randomization and code governance model
The decision hinges on where allocation logic should live and how tightly treatment code decisions must track enrollment and dispensing operational states. Tools differ most in configuration depth, how they expose automation and API surfaces for trial operations, and how their audit behavior holds up when eligibility-based enrollment and emergency access paths activate.
Pick the tool that matches the required linkage between allocation and operational event states
Choose Castor EDC when randomization actions must stay synchronized with study configuration and treatment code handling in one operational workflow. Choose OpenClinica when assignment outcomes must mirror EDC-style study events and status transitions across sites.
Decide how emergency unblinding should be governed at the treatment code layer
Choose Signant Health IRT when emergency unblinding and treatment code release must be managed inside the same centralized allocation workflow. Choose Endpoint Clinical PULSE or Almac IXRS when emergency access is required with controlled audit-trail visibility across allocation and code changes.
Match kit assignment and dispensing execution to the tool’s treatment code lifecycle coverage
Choose Oracle Clinical One Randomization and Trial Supply Management when end-to-end treatment code management must coordinate randomization schedules with kit assignment and investigational product dispensing execution. Choose 4G Clinical Prancer when drug dispensing operations require tightly governed treatment code lifecycle workflows within one operational path.
Select the configuration philosophy based on stratification complexity and site assignment patterns
Choose Clario IRT when allocation rules can be expressed through configuration and then applied through interactive response endpoints for site-facing assignment and treatment code propagation. Choose Signant Health IRT when cohort-aware handling across multi-group enrollment patterns must remain tightly controlled across many sites.
Choose an operating model for data governance where allocation outputs must be stored
Choose REDCap when allocation decisions must be persisted as part of the same project workspace that holds eCRF data. Choose Oracle Clinical One Randomization and Trial Supply Management when centralized governance must cover both randomization and supply execution under Oracle administration workflows.
Plan integration throughput and automation depth before committing to complex trial stacks
Choose Castor EDC or OpenClinica when the trial stack expects deeper alignment between enrollment states and randomization execution with audit tracking. Choose Clario IRT, Endpoint Clinical PULSE, or Almac IXRS when site-facing interactive response endpoints must be coordinated with enrollment and code workflows, but integration effort is budgeted for complex event mappings.
Who benefits from each randomization and treatment code governance model
Not all trials need the same coupling between randomization, treatment code handling, and dispensing operations. Teams should select based on where governance must be enforced, how many operational states must drive assignment release, and how emergency unblinding must behave under audit traceability requirements.
Sponsors running centralized allocation across many sites with strict cross-site consistency needs
Signant Health IRT focuses on centralized treatment code workflows that reduce allocation inconsistencies and supports cohort-aware handling for multi-group enrollment patterns.
Trial teams that require audit trail coverage that stays synchronized with configuration and treatment code steps
Castor EDC provides operational audit trail behavior tied to study configuration and treatment code handling so assignment actions remain traceable to the configuration used.
Organizations that need randomization behavior mirrored to EDC enrollment and status events
OpenClinica keeps study-level randomization configuration linked to EDC-style study events and supports audit tracking tied to assignment-relevant study changes.
Companies coordinating randomization with kit assignment and investigational product dispensing under a single governance workflow
Oracle Clinical One Randomization and Trial Supply Management is designed for end-to-end treatment code management that coordinates randomization schedules with kit and dispensing execution.
Teams using a single REDCap workspace to govern both allocation outputs and case data
REDCap stores allocation outcomes in the same project records as trial data and supports event-driven automation that can trigger assignment and downstream data collection.
Common failure modes when implementing Clinical Trial Randomization Software
Randomization failures typically come from governance gaps rather than from incorrect random number generation. Most implementation problems happen when eligibility inputs, enrollment status transitions, and treatment code release logic are not mapped with the same operational definitions across systems and teams.
Treating audit trail requirements as an afterthought instead of tying them to configuration and operational code steps
Castor EDC is built to keep operational audit trail behavior synchronized with study configuration and treatment code handling, which helps prevent missing traceability during audits of allocation actions.
Configuring emergency unblinding without ensuring it follows the same treatment code governance path used for routine assignment
Signant Health IRT combines emergency unblinding and treatment code handling inside the centralized allocation workflow, which reduces the risk of inconsistent code release behavior under urgent access.
Underestimating the integration work needed when EDC enrollment events must drive randomization execution and audit behavior
OpenClinica ties randomization outcomes to EDC-style study events and status records, which can increase setup effort when randomization must mirror EDC workflows with complex operational states.
Assuming a randomization tool automatically coordinates dispensing execution without a disciplined treatment code lifecycle workflow
Oracle Clinical One Randomization and Trial Supply Management explicitly coordinates treatment code generation with kit assignment workflows, so operational mismatches usually trace back to insufficient study provisioning discipline.
Using interactive response endpoints without aligning stratification factors and enrollment caps to the site-facing assignment workflow
Clario IRT and Signant Health IRT can require increased setup complexity when multiple stratification factors and enrollment caps are used, so configuration and governance of those inputs must be planned with the same operational definitions.
How We Selected and Ranked These Tools
We evaluated Castor EDC, Signant Health IRT, OpenClinica, Oracle Clinical One Randomization and Trial Supply Management, 4G Clinical Prancer, Clario IRT, Endpoint Clinical PULSE, REDCap, Perceptive MyIRT, and Almac IXRS using feature coverage, operational governance depth, and usability for trial operations. Features accounted for 40% of the ranking, and ease and value each accounted for 30%.
Castor EDC separated itself by providing operational audit trail behavior that stays tied to study configuration and treatment code handling, which supports traceability across randomization and code release operations. The scoring also reflected how each tool connects randomization execution to site-facing assignment and emergency access workflows without leaving audit behavior behind.
Frequently Asked Questions About clinical trial randomization software
How does Medidata Rave RTSM differ from Clario IRT when connecting randomization to dispensing operations?
Which system handles emergency unblinding and treatment code access under the same operational allocation workflow?
How do Castor EDC and OpenClinica keep audit traceability tied to assignment-relevant configuration changes?
What breaks if randomization schedule provisioning and treatment code generation are not coordinated with kit and dispense execution?
When does REDCap become a workable choice versus deploying an RTSM-style tool like Perceptive MyIRT?
How do 4G Clinical Prancer and Almac IXRS handle treatment code access controls for site dispensing operations?
What integration expectations should teams plan for when moving from EDC-driven enrollment into Castor EDC or Clario IRT?
How does role-based access and audit logging differ between Endpoint Clinical PULSE and Perceptive MyIRT for operational governance?
Tools reviewed
Primary sources checked during evaluation.
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