id stringclasses 6
values | prompt stringclasses 6
values | gold_json stringclasses 6
values | reference_notes stringclasses 4
values |
|---|---|---|---|
PK-001 | Quad PK analysis. Oncology trial. Trough samples collected 3–5 hours outside protocol window at two sites. Bioanalytical CV rises to 18%. Dose reductions implemented without PK confirmation. Governance: interim exposure-response analysis in 2 weeks. Determine PK integrity risk and action. Return strict JSON only. | {"pk_integrity_risk":true,"risk_type":"sampling_window_deviation_with_variance","driver_nodes":["out-of-window trough sampling cluster","elevated bioanalytical CV","dose reductions without PK confirmation","imminent interim exposure-response analysis"],"recommended_action":"sampling_and_bioanalysis_reconciliation","act... | confidence":0.9} |
PK-002 | Quad PK analysis. Cardiology trial. Peak samples missing at high-enrolling sites. Central lab calibration updated mid-study. Dose escalation accelerated due to recruitment pace. Governance: DSMB review next week. Determine risk and action. JSON only. | {"pk_integrity_risk":true,"risk_type":"peak_missing_with_calibration_shift","driver_nodes":["missing peak samples cluster","lab calibration update","accelerated dose escalation","DSMB timing"],"recommended_action":"peak_and_calibration_audit","action_detail":["recover or flag missing peaks","verify calibration impact",... | confidence":0.88} |
PK-003 | Quad PK analysis. Neurology trial. PK samples stored beyond stability window at remote sites. Shipping delays reported. Dose adjustments based on interim PK summary. Governance: regulator inquiry pending. Determine risk and action. JSON only. | {"pk_integrity_risk":true,"risk_type":"stability_window_breach_with_shipping_delay","driver_nodes":["sample stability window breach","shipping delays","dose changes from interim summary","regulator inquiry"],"recommended_action":"stability_and_dose_review","action_detail":["exclude unstable samples","audit shipping log... | confidence":0.89} |
PK-004 | Quad PK analysis. Pulmonary trial. Sparse sampling schedule modified at one region. Assay sensitivity lower for new batch. High-dose cohort expanded early. Governance: interim PK report due. Determine risk and action. JSON only. | {"pk_integrity_risk":true,"risk_type":"sampling_schedule_shift_with_assay_sensitivity_drop","driver_nodes":["regional schedule modification","lower assay sensitivity batch","early high-dose expansion","interim report deadline"],"recommended_action":"schedule_and_assay_recalibration","action_detail":["restore protocol s... | confidence":0.87} |
PK-005 | Quad PK analysis. Metabolic trial. Time-of-dose documentation missing in 15%. Sample processing delay averages 10 hours. Dose titration decisions ongoing. Governance: submission module draft in preparation. Determine risk and action. JSON only. | {"pk_integrity_risk":true,"risk_type":"dose_time_missing_with_processing_delay","driver_nodes":["missing dose time documentation","processing delay cluster","active titration decisions","submission drafting"],"recommended_action":"dose_time_and_processing_fix","action_detail":["capture accurate dose times","reduce proc... | confidence":0.88} |
PK-006 | Quad PK analysis. Vaccine trial. Early cohort PK values higher at two sites. Freezer temperature excursions reported. Assay run order not randomized. Governance: regulatory submission deadline fixed. Determine risk and action. JSON only. | {"pk_integrity_risk":true,"risk_type":"temperature_excursion_with_run_order_bias","driver_nodes":["site-specific PK elevation","freezer temperature excursions","non-randomized assay run order","submission deadline"],"recommended_action":"temperature_and_run_order_audit","action_detail":["review freezer logs","assess as... | confidence":0.9} |
Clarus Clinical Quad Coupling PK Integrity v0.1
Purpose
Detect PK integrity distortion driven by four interacting nodes.
Quad nodes
- Sampling window deviation
- Bioanalytical or stability variance
- Dose adjustment decisions
- Governance interim or submission timing
Input
One vignette.
Output
Strict JSON only.
Required keys
- pk_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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