id stringclasses 6
values | prompt stringclasses 6
values | gold_json stringclasses 4
values | reference_notes stringclasses 6
values | __index_level_0__ stringclasses 6
values |
|---|---|---|---|---|
Quad ePRO integrity analysis. Neurology trial. Daily symptom diary completion drops from 82% to 49% at two sites after app update. Reminder notifications disabled by default on new phones. Site staff began coaching participants to fill diaries during clinic visits. Governance: interim patient-reported endpoint readout ... | {"epro_integrity_risk":true,"risk_type":"compliance_drop_with_notification_and_coaching_bias","driver_nodes":["completion drop cluster","app update and notification default off","site coaching during visits","imminent interim PRO readout"],"recommended_action":"restore_notifications_and_audit_entries","action_detail":[... | confidence":0.9} | App update + coaching. | EPRO-001 |
Quad ePRO integrity analysis. Oncology trial. Pain scores improve sharply at high-enrolling sites. Device swap to tablets occurred due to phone compatibility issues. Data sync delay averages 3 days. Governance: submission narrative relies on pain endpoint. Determine risk and action. JSON only. | {"epro_integrity_risk":true,"risk_type":"device_swap_with_sync_delay_and_endpoint_dependence","driver_nodes":["pain improvement cluster","device swap to tablets","sync delay","submission dependence on endpoint"],"recommended_action":"device_and_sync_reconciliation","action_detail":["compare scores pre/post device swap"... | confidence":0.88} | Device artifact risk. | EPRO-002 |
Quad ePRO integrity analysis. Cardiology trial. Completion rates stable overall but missingness spikes on weekends at one region. Reminder schedule configured only Mon–Fri. Staffing reduced for weekend support. Governance: DSMB review next week includes PRO tolerability. Determine risk and action. JSON only. | {"epro_integrity_risk":true,"risk_type":"weekend_missingness_due_to_reminder_configuration","driver_nodes":["weekend missingness spike","weekday-only reminders","reduced weekend support","DSMB timing"],"recommended_action":"weekend_reminder_and_support_fix","action_detail":["extend reminders to weekends","add weekend s... | confidence":0.87} | Weekend config. | EPRO-003 |
Quad ePRO integrity analysis. Pulmonary trial. PRO entries surge the day before site visits. App allows offline entry with later upload. Site staff remind participants during scheduling calls. Governance: interim exacerbation analysis uses PRO triggers. Determine risk and action. JSON only. | {"epro_integrity_risk":true,"risk_type":"visit_proximity_backfill_bias","driver_nodes":["pre-visit entry surge","offline entry then upload","visit-call reminders","interim analysis tie to PRO triggers"],"recommended_action":"backfill_detection_and_policy_reset","action_detail":["detect timestamp/upload mismatches","lim... | confidence":0.89} | Backfill node. | EPRO-004 |
Quad ePRO integrity analysis. Metabolic trial. Completion drops after OS update. Battery optimization kills background reminders. Sites report increased manual calls to participants. Governance: compliance audit scheduled. Determine risk and action. JSON only. | {"epro_integrity_risk":true,"risk_type":"os_update_with_battery_reminder_failure","driver_nodes":["completion drop post OS update","battery optimization disables reminders","manual calling by sites","audit scheduled"],"recommended_action":"os_configuration_and_call_audit","action_detail":["publish device settings guide... | confidence":0.88} | OS reminder failure. | EPRO-005 |
Quad ePRO integrity analysis. Vaccine trial. Symptom diary completion high but identical text appears across participants at one site. Copy-paste suspected. Staff workload high. Governance: regulator questions data integrity. Determine risk and action. JSON only. | {"epro_integrity_risk":true,"risk_type":"templated_entries_under_workload_pressure","driver_nodes":["duplicate diary text cluster","copy-paste suspicion","high staff workload","regulator scrutiny"],"recommended_action":"duplicate_detection_and_site_intervention","action_detail":["run duplicate text detection","intervie... | confidence":0.9} | Duplicate text. | EPRO-006 |
Clarus Clinical Quad Coupling ePRO Integrity v0.1
What this dataset is
This dataset tests whether a model can detect ePRO integrity risk driven by four interacting nodes.
Quad coupling nodes
- Compliance drop or patterned missingness
- Device or app update and reminder configuration
- Site influence or coaching and backfill behavior
- Governance pressure from interim reads or submission reliance
Input
- One vignette
Output
Return strict JSON only.
Required output JSON keys
- epro_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
{"id":"EPRO-T01","output":"{...your json...}"}
Run
python scorer.py --gold_csv data/test.csv --preds_jsonl preds.jsonl
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