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Quad adjudication analysis. Phase III cardiology trial. Primary endpoint rate increases at two high-enrolling sites. Adjudication turnaround drops from 14 to 4 days. One adjudicator replaced mid-study. Governance: submission timeline fixed. Determine adjudication integrity risk and action. Return strict JSON only.
{"adjudication_integrity_risk":true,"risk_type":"adjudication_drift_under_operational_pressure","driver_nodes":["endpoint cluster at high-enrolling sites","accelerated adjudication turnaround","adjudicator replacement","fixed submission timeline"],"recommended_action":"adjudication_process_audit","action_detail":["audi...
confidence":0.9}
Turnaround node.
ADJ-001
Quad adjudication analysis. Oncology trial. Tumor response rates rise after imaging vendor change. Blinding logs incomplete. Monitoring visit delayed. Governance: interim efficacy look imminent. Determine risk and action. JSON only.
{"adjudication_integrity_risk":true,"risk_type":"vendor_shift_with_blinding_gap","driver_nodes":["response rate increase post-vendor change","imaging vendor switch","incomplete blinding logs","interim timing"],"recommended_action":"vendor_and_blinding_reconciliation","action_detail":["re-review imaging samples","verify...
confidence":0.88}
Vendor node.
ADJ-002
Quad adjudication analysis. Neurology trial. Stroke endpoint classification varies by region. Training refresh overdue. Single adjudicator handling 70% of cases. Governance: regulator inspection expected. Determine risk and action. JSON only.
{"adjudication_integrity_risk":true,"risk_type":"regional_variability_with_single_reviewer_bias","driver_nodes":["regional endpoint variability","training overdue","single adjudicator dominance","inspection expectation"],"recommended_action":"regional_recalibration_and_training","action_detail":["compare regional class...
confidence":0.87}
Regional node.
ADJ-003
Quad adjudication analysis. Pulmonary trial. Exacerbation endpoints stable overall but decline sharply at remote sites. Remote review introduced recently. Blinding confirmation incomplete. Governance: DSMB review next week. Determine risk and action. JSON only.
{"adjudication_integrity_risk":true,"risk_type":"remote_review_bias_with_blinding_gap","driver_nodes":["remote site endpoint decline","recent remote review shift","incomplete blinding confirmation","DSMB timing"],"recommended_action":"remote_process_and_blinding_audit","action_detail":["audit remote adjudications","ver...
confidence":0.89}
Remote node.
ADJ-004
Quad adjudication analysis. Metabolic trial. Secondary endpoint upgraded to co-primary mid-study. Adjudication charter amended. Training not completed at all sites. Governance: submission package in preparation. Determine risk and action. JSON only.
{"adjudication_integrity_risk":true,"risk_type":"charter_change_without_full_training","driver_nodes":["endpoint status upgrade","charter amendment","incomplete training","submission preparation"],"recommended_action":"charter_and_training_completion","action_detail":["complete adjudicator training","document charter c...
confidence":0.88}
Charter node.
ADJ-005
Quad adjudication analysis. Vaccine trial. Severe adverse event adjudications decrease at two high-enrolling sites. Reviewer workload increased. Blinding confirmation missing for 10% of cases. Governance: regulator submission deadline fixed. Determine risk and action. JSON only.
{"adjudication_integrity_risk":true,"risk_type":"workload_bias_with_blinding_missingness","driver_nodes":["SAE decline at clustered sites","increased reviewer workload","missing blinding confirmation","fixed submission deadline"],"recommended_action":"workload_and_blinding_review","action_detail":["rebalance adjudicati...
confidence":0.9}
Workload node.
ADJ-006

Clarus Clinical Quad Coupling Endpoint Adjudication Integrity v0.1

Purpose
Detect adjudication drift driven by four interacting nodes.

Quad nodes

  • Endpoint cluster shift
  • Blinding gap or reviewer dominance
  • Operational or vendor process change
  • Governance submission or review pressure

Input
One vignette.

Output
Strict JSON only.

Required keys

  • adjudication_integrity_risk
  • risk_type
  • driver_nodes
  • recommended_action
  • action_detail
  • rationale
  • confidence

Files
data/train.csv
data/test.csv
scorer.py

Run scoring
Create JSONL predictions.

python scorer.py --gold_csv data/test.csv --preds_jsonl preds.jsonl

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