id stringclasses 6
values | prompt stringclasses 6
values | gold_json stringclasses 5
values | reference_notes stringclasses 6
values | __index_level_0__ stringclasses 6
values |
|---|---|---|---|---|
Quad enrollment analysis. Oncology trial. Screen failure rate drops from 42% to 18% at two high-enrolling sites. Inclusion labs missing for 12% of enrolled patients. Recruitment targets increased by sponsor. Governance: interim analysis in 3 weeks. Determine enrollment drift risk and action. Return strict JSON only. | {"enrollment_drift_risk":true,"risk_type":"criteria_relaxation_under_pressure","driver_nodes":["screen failure drop cluster","missing inclusion labs","recruitment target increase","imminent interim analysis"],"recommended_action":"screening_audit_and_retraining","action_detail":["audit recent enrollments","restore lab ... | confidence":0.89} | Criteria drift. | ENR-001 |
Quad enrollment analysis. Cardiology trial. One region enrolls faster with lower baseline risk scores. Site selection favored high-volume centers. Screening logs incomplete. Governance: DSMB review next month. Determine risk and action. JSON only. | {"enrollment_drift_risk":true,"risk_type":"site_selection_bias","driver_nodes":["fast enrollment region","lower baseline risk","site selection bias","incomplete screening logs"],"recommended_action":"baseline_and_screening_review","action_detail":["review baseline data","complete screening logs","rebalance enrollment",... | confidence":0.87} | Site bias. | ENR-002 |
Quad enrollment analysis. Neurology trial. Eligibility deviations cluster at sites with staffing shortages. Screening visit time reduced. Training refresh overdue. Governance: regulator inquiry pending. Determine risk and action. JSON only. | {"enrollment_drift_risk":true,"risk_type":"staffing_screening_gap","driver_nodes":["eligibility deviation cluster","staffing shortage","reduced screening time","overdue training"],"recommended_action":"staffing_and_training_intervention","action_detail":["increase screening staff","deliver refresher training","audit el... | confidence":0.86} | Staffing node. | ENR-003 |
Quad enrollment analysis. Pulmonary trial. Enrollment rises after advertising campaign. Baseline severity scores lower. Screening documentation incomplete. Governance: interim efficacy tied to enrollment pace. Determine risk and action. JSON only. | {"enrollment_drift_risk":true,"risk_type":"advertising_induced_population_shift","driver_nodes":["enrollment surge","lower severity baseline","incomplete screening docs","efficacy tied to pace"],"recommended_action":"population_and_doc_audit","action_detail":["audit baseline severity","complete documentation","pause ta... | confidence":0.85} | Advertising pressure. | ENR-004 |
Quad enrollment analysis. Metabolic trial. Inclusion criteria modified at one site without approval. Screening logs delayed. Recruitment bonus introduced. Governance: compliance audit scheduled. Determine risk and action. JSON only. | {"enrollment_drift_risk":true,"risk_type":"unauthorized_criteria_change","driver_nodes":["criteria modification","screening log delay","recruitment bonus","audit scheduled"],"recommended_action":"criteria_and_log_reconciliation","action_detail":["restore approved criteria","update logs","audit enrolled patients","prepa... | confidence":0.88} | Criteria change. | ENR-005 |
Quad enrollment analysis. Vaccine trial. Enrollment cluster shows younger patients only. Age eligibility documentation incomplete. Outreach focused on one demographic. Governance: regulator review upcoming. Determine risk and action. JSON only. | {"enrollment_drift_risk":true,"risk_type":"demographic_selection_bias","driver_nodes":["age cluster","incomplete age docs","targeted outreach","regulator review"],"recommended_action":"demographic_and_doc_audit","action_detail":["verify age eligibility","broaden outreach","update documentation","prepare regulator brief... | confidence":0.87} | Demographic node. | ENR-006 |
Clarus Clinical Quad Coupling Enrollment Criteria Drift Site Selection Bias Screening Pressure v0.1
Purpose
Detect enrollment population drift driven by four interacting nodes.
Quad nodes
- Criteria relaxation or documentation gap
- Site selection or recruitment bias
- Screening workflow pressure
- Governance or interim timing pressure
Input
One vignette.
Output
Strict JSON only.
Required keys
- enrollment_drift_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 and run:
python scorer.py --gold_csv data/test.csv --preds_jsonl preds.jsonl
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