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ClarusC64
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clarus-population-framework-transition-integrity-v0.1

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clinical-trials

population-integrity

framework-transition

regulatory-review

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sample_id string	source_framework string	target_framework string	concept string	source_definition string	target_definition string	claim string	option_a string	option_b string	task string	correct_option string	required_note string	required_keywords string	axis string	difficulty int64
CPFT-0001	Registry	Publication	Inclusion criteria	Age 18–75	Age 18–65	Claim same enrolled population	Invalid correspondence, age range narrowed	Valid correspondence, minor edit	Judge correspondence and write note	A	State 18–75 vs 18–65 and flag narrowed eligibility	18–75\|18–65\|age\|narrowed\|eligibility	inclusion_criteria	2
CPFT-0002	Registry	SAP	Analysis set	ITT includes all randomized	mITT excludes no-dose patients	Treat ITT and mITT as identical	Invalid correspondence, analysis set changed	Valid correspondence, mITT fully mapped	Judge correspondence and write note	A	State ITT vs mITT and require explicit exclusion mapping	ITT\|mITT\|exclude\|no dose\|mapping	analysis_set	3
CPFT-0003	Protocol	Publication	Exclusion criteria	No prior anti-PD-1	Prior anti-PD-1 allowed in analysis	Assume criteria unchanged	Invalid correspondence, exposure rule changed	Valid correspondence, same rule	Judge correspondence and write note	A	State prior anti-PD-1 change and flag population drift	prior anti-PD-1\|allowed\|exposure\|drift\|criteria	exclusion_criteria	3
CPFT-0004	Protocol	SAP	Stratification factor	Stratify by EGFR status	Stratify by EGFR and smoking	Assume same strata	Partial correspondence, strata expanded	Valid correspondence, unchanged	Judge correspondence and write note	A	State added smoking stratification and note comparability impact	EGFR\|smoking\|stratify\|expanded\|comparability	stratification	2
CPFT-0005	Registry	Publication	High-risk subgroup	High risk = prior MI	High risk = prior MI or diabetes	Treat subgroup as same	Partial correspondence, definition broadened	Valid correspondence, same subgroup	Judge correspondence and write note	A	State MI-only vs MI-or-diabetes and flag broadened subgroup	MI\|diabetes\|high risk\|broadened\|definition	subgroup_definition	2
CPFT-0006	Protocol	Publication	Missing data handling	All randomized included	Exclude patients missing baseline scan	Assume cohort unchanged	Invalid correspondence, exclusions added	Valid correspondence, same cohort	Judge correspondence and write note	A	State baseline scan exclusion and flag post-randomization selection	missing baseline\|exclude\|post-randomization\|selection\|cohort	missingness_selection	3
CPFT-0007	Registry	Publication	Enrollment geography	Global sites	EU sites only in analysis	Treat as same population	Invalid correspondence, geography restricted	Valid correspondence, same sites	Judge correspondence and write note	A	State global vs EU-only and flag restricted external validity	global\|EU only\|geography\|restricted\|external validity	population_scope	3
CPFT-0008	Protocol	SAP	Per-protocol set	Not defined	Per-protocol excludes major deviations	Report PP as primary without mapping	Invalid correspondence, primary set changed	Valid correspondence, PP secondary only	Judge correspondence and write note	A	State per-protocol introduced and require mapping from ITT	per-protocol\|deviations\|primary\|mapping\|ITT	analysis_set_shift	3
CPFT-0009	Registry	Publication	Run-in period	No run-in	2-week placebo run-in excludes non-adherent	Treat as same enrolled group	Invalid correspondence, selection introduced	Valid correspondence, run-in documented and mapped	Judge correspondence and write note	A	State run-in selection and flag adherence-based exclusion	run-in\|placebo\|non-adherent\|selection\|exclude	selection_mechanism	3
CPFT-0010	Protocol	Publication	Substudy cohort	All participants eligible	Only biomarker-positive included	Treat substudy results as trial-wide	Invalid correspondence, cohort restricted	Valid correspondence, restricted cohort stated	Judge correspondence and write note	A	State biomarker-positive restriction and block generalization	biomarker-positive\|restricted\|cohort\|generalize\|trial-wide	generalization	3

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

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