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- ---
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- license: mit
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- ---
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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+ ---
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+ license: mit
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+ language:
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+ - en
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+ pretty_name: Clarus Population Framework Transition Integrity v0.1
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+ tags:
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+ - clarus
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+ - clinical-trials
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+ - population-integrity
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+ - framework-transition
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+ - registry-audit
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+ - regulatory-review
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+ task_categories:
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+ - text-classification
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+ size_categories:
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+ - 1K<n<10K
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+ ---
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+
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+ Clarus Population Framework Transition Integrity v0.1
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+
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+ What this dataset tests
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+
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+ - You track how the study population is defined as it moves across formal frameworks
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+ - You detect when inclusion, exclusion, or analysis sets change without explicit mapping
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+ - You flag population drift introduced between planning and reporting stages
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+
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+ Framework transitions covered
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+
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+ - Trial registry → protocol
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+ - Protocol → statistical analysis plan
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+ - SAP → publication
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+
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+ Scope
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+
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+ - One trial
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+ - Multiple population definitions
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+ - Multiple formal frameworks
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+
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+ Typical failure modes
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+
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+ - Registry eligibility differs from published cohort
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+ - ITT redefined as modified ITT without mapping
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+ - Post-randomization exclusions introduced
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+ - Per-protocol sets promoted without justification
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+ - Subgroup restrictions applied retroactively
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+
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+ What this dataset does not test
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+
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+ - Internal narrative rhetoric within a single section
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+ - Endpoint definition changes
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+ - Safety or adjudication rule drift
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+
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+ Task format
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+
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+ - Each row presents a population definition in a source framework and a target framework
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+ - The model judges whether correspondence is valid
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+ - The model must name the mechanism of drift when correspondence fails
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+
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+ Label meaning
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+
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+ - A indicates invalid or unsupported population correspondence
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+ - B indicates valid correspondence with sufficient justification
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+
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+ Use cases
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+
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+ - Automated audit of trial registries versus publications
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+ - Systematic review population vetting
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+ - Regulatory submission consistency checks
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+
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+ Version note
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+
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+ - v0.1 establishes baseline population transition auditing
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+ - Higher-resolution variants may add explicit mapping requirements