Datasets:
Tasks:
Text Classification
Modalities:
Text
Formats:
csv
Languages:
English
Size:
< 1K
Tags:
clarus
clinical-trials
population-integrity
framework-transition
registry-audit
regulatory-review
License:
Update README.md
Browse files
README.md
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---
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license: mit
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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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Clarus Population Framework Transition Integrity v0.1
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What this dataset tests
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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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Framework transitions covered
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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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Scope
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- One trial
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- Multiple population definitions
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- Multiple formal frameworks
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Typical failure modes
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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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What this dataset does not test
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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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Task format
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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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Label meaning
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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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Use cases
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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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Version note
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- v0.1 establishes baseline population transition auditing
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- Higher-resolution variants may add explicit mapping requirements
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