{
  "schema_version": "2.0",
  "checklist_id": "STAT-REPRO-SYNTHETIC-001",
  "study_design": "randomized_trial",
  "specialist_review": {
    "needed": "undetermined",
    "areas": [],
    "requested": false
  },
  "items": [
    {
      "id": "question.estimand_alignment",
      "category": "question",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check alignment among the question, target quantity, design, analysis, and interpretation"
    },
    {
      "id": "design.unit_and_independence",
      "category": "design",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Identify the experimental or observational unit and assess dependence"
    },
    {
      "id": "design.sample_size_precision",
      "category": "design",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess prospective sample-size or precision justification and assumptions"
    },
    {
      "id": "design.allocation_randomization",
      "category": "design",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess sequence generation, allocation concealment, or sampling procedures as applicable"
    },
    {
      "id": "design.blinding",
      "category": "design",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess who was blinded or masked and likely consequences when blinding was infeasible"
    },
    {
      "id": "data.inclusion_exclusion",
      "category": "data",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Trace prespecified inclusion, exclusion, attrition, and analysis populations"
    },
    {
      "id": "data.missing_data",
      "category": "data",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess missingness amounts, reasons, assumptions, methods, and sensitivity analyses"
    },
    {
      "id": "data.outliers_transformations",
      "category": "data",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check rules for exclusions, transformations, detection limits, and influential observations"
    },
    {
      "id": "analysis.prespecification",
      "category": "analysis",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Compare analyses with the protocol, registration, and statistical analysis plan"
    },
    {
      "id": "analysis.method_design_alignment",
      "category": "analysis",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess whether methods match the design, outcome type, estimand, and sampling structure"
    },
    {
      "id": "analysis.assumptions_diagnostics",
      "category": "analysis",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess model assumptions, diagnostics, robustness, and fallback analyses"
    },
    {
      "id": "analysis.multiplicity",
      "category": "analysis",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess outcome hierarchy, repeated looks, multiple comparisons, and error control"
    },
    {
      "id": "analysis.clustering_repeated_measures",
      "category": "analysis",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess clustering, pairing, repeated measures, nesting, and time dependence"
    },
    {
      "id": "results.effect_sizes_uncertainty",
      "category": "results",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check effect estimates and compatible uncertainty intervals, not thresholded p-values alone"
    },
    {
      "id": "results.denominators_flow",
      "category": "results",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Reconcile denominators, participant or sample flow, exclusions, and analysis populations"
    },
    {
      "id": "results.complete_outcomes_harms",
      "category": "results",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check all prespecified outcomes, null findings, adverse events, and deviations"
    },
    {
      "id": "reproducibility.data_materials_access",
      "category": "reproducibility",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess data, materials, protocol, repository, and justified access restrictions"
    },
    {
      "id": "reproducibility.code_environment_parameters",
      "category": "reproducibility",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess code, software versions, environments, seeds, parameters, and run instructions"
    },
    {
      "id": "reproducibility.provenance_versions",
      "category": "reproducibility",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Trace data provenance, transformations, versioned artifacts, and accession identifiers"
    },
    {
      "id": "ethics.approval_consent_governance",
      "category": "ethics",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Assess approvals, consent, welfare, privacy, governance, and conflicts as applicable"
    },
    {
      "id": "interpretation.claim_evidence_causality",
      "category": "interpretation",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check claim strength against design, evidence, uncertainty, alternatives, and generalizability"
    },
    {
      "id": "integrity.deviations_selective_reporting",
      "category": "integrity",
      "applicability": "applicable",
      "status": "not_assessed",
      "evidence_locations": [],
      "note": "",
      "requested_action": "Check unexplained deviations, outcome switching, selective reporting, and internal inconsistencies"
    }
  ]
}