README.md

metadata

license: mit
language:
  - en
pretty_name: Clarus Population Framework Transition Integrity v0.1
tags:
  - clarus
  - clinical-trials
  - population-integrity
  - framework-transition
  - registry-audit
  - regulatory-review
task_categories:
  - text-classification
size_categories:
  - 1K<n<10K

Clarus Population Framework Transition Integrity v0.1

What this dataset tests

• You track how the study population is defined as it moves across formal frameworks
• You detect when inclusion, exclusion, or analysis sets change without explicit mapping
• You flag population drift introduced between planning and reporting stages

Framework transitions covered

• Trial registry → protocol
• Protocol → statistical analysis plan
• SAP → publication

Scope

• One trial
• Multiple population definitions
• Multiple formal frameworks

Typical failure modes

• Registry eligibility differs from published cohort
• ITT redefined as modified ITT without mapping
• Post-randomization exclusions introduced
• Per-protocol sets promoted without justification
• Subgroup restrictions applied retroactively

What this dataset does not test

• Internal narrative rhetoric within a single section
• Endpoint definition changes
• Safety or adjudication rule drift

Task format

• Each row presents a population definition in a source framework and a target framework
• The model judges whether correspondence is valid
• The model must name the mechanism of drift when correspondence fails

Label meaning

• A indicates invalid or unsupported population correspondence
• B indicates valid correspondence with sufficient justification

Use cases

• Automated audit of trial registries versus publications
• Systematic review population vetting
• Regulatory submission consistency checks

Version note

• v0.1 establishes baseline population transition auditing
• Higher-resolution variants may add explicit mapping requirements