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 data lock analysis. Phase III oncology trial. Query backlog 3.2 per subject at two sites. Source verification incomplete for 14%. Lab vendor file delayed 5 days. Governance: database lock in 2 weeks. Determine lock readiness risk and action. Return strict JSON only. | {"lock_readiness_risk":true,"risk_type":"query_backlog_with_source_missingness","driver_nodes":["high query backlog cluster","incomplete source verification","vendor file delay","imminent database lock"],"recommended_action":"clear_queries_and_verify_source","action_detail":["prioritize backlog clearance","complete SDV for critical fields","obtain delayed vendor files","reconfirm lock timeline"],"rationale":"High backlog with incomplete SDV and delayed vendor files risks locking with unresolved discrepancies. Lock timing requires backlog clearance and source verification before proceeding. | confidence":0.9} | Backlog node. | LOCK-001 |
Quad data lock analysis. Cardiology trial. Missingness rises in key endpoints at one region. Monitoring visits postponed. Data transfer lag from central lab. Governance: DSMB review next week. Determine risk and action. JSON only. | {"lock_readiness_risk":true,"risk_type":"endpoint_missingness_under_monitoring_delay","driver_nodes":["endpoint missingness cluster","monitoring postponement","lab transfer lag","DSMB timing"],"recommended_action":"endpoint_and_transfer_reconciliation","action_detail":["restore monitoring visits","resolve lab transfer delays","fill critical missing fields","inform DSMB of readiness risk"],"rationale":"Endpoint missingness with monitoring delays and lab transfer lag suggests incomplete dataset integrity. DSMB timing requires reconciliation before lock or review. | confidence":0.88} | Missingness node. | LOCK-002 |
Quad data lock analysis. Neurology trial. ePRO uploads missing for 11%. Site staffing reduced. Query response time doubled. Governance: regulator submission deadline fixed. Determine risk and action. JSON only. | {"lock_readiness_risk":true,"risk_type":"epro_missingness_with_staffing_gap","driver_nodes":["ePRO missing cluster","reduced staffing","slow query response","submission deadline"],"recommended_action":"epro_and_query_recovery","action_detail":["recover ePRO uploads","add temporary data staff","accelerate query response","adjust submission timeline if needed"],"rationale":"High ePRO missingness with staffing gap and slow queries risks incomplete patient-reported outcomes at lock. Fixed submission deadline requires recovery and potential timeline adjustment. | confidence":0.87} | ePRO node. | LOCK-003 |
Quad data lock analysis. Pulmonary trial. SAE reconciliation incomplete at two sites. Vendor safety file delayed. Monitoring remote only. Governance: interim analysis tied to lock. Determine risk and action. JSON only. | {"lock_readiness_risk":true,"risk_type":"sae_reconciliation_gap","driver_nodes":["SAE reconciliation incomplete","vendor delay","remote monitoring","interim tie"],"recommended_action":"sae_and_vendor_reconciliation","action_detail":["complete SAE reconciliation","obtain vendor safety file","targeted on-site review","inform interim analysis team"],"rationale":"Incomplete SAE reconciliation with vendor delays and remote-only monitoring risks locking without full safety alignment. Interim tie requires reconciliation before analysis. | confidence":0.89} | SAE node. | LOCK-004 |
Quad data lock analysis. Metabolic trial. Visit windows deviated at high-volume sites. Date fields inconsistent. Query backlog rising. Governance: compliance audit scheduled. Determine risk and action. JSON only. | {"lock_readiness_risk":true,"risk_type":"visit_window_and_date_inconsistency","driver_nodes":["visit deviation cluster","date field inconsistency","query backlog rise","audit scheduled"],"recommended_action":"date_and_visit_repair","action_detail":["standardize date fields","reconcile visit windows","clear query backlog","prepare audit documentation"],"rationale":"Visit window deviations and inconsistent dates with rising backlog risk inaccurate timelines at lock. Audit timing requires repair and documentation before proceeding. | confidence":0.86} | Date node. | LOCK-005 |
Quad data lock analysis. Vaccine trial. Conmed data missing in 19%. Safety reconciliation pending. Data transfer lag 3 days. Governance: submission package due in 10 days. Determine risk and action. JSON only. | {"lock_readiness_risk":true,"risk_type":"conmed_missing_with_safety_pending","driver_nodes":["conmed missing cluster","safety reconciliation pending","transfer lag","submission deadline"],"recommended_action":"conmed_and_safety_completion","action_detail":["complete conmed entry","finalize safety reconciliation","resolve transfer lag","confirm submission readiness"],"rationale":"High conmed missingness with pending safety reconciliation and transfer lag risks incomplete safety context at submission. Deadline requires completion before lock and filing. | confidence":0.88} | Conmed node. | LOCK-006 |
Clarus Clinical Quad Coupling Data Lock Readiness v0.1
Purpose
Detect lock-readiness risk driven by four interacting nodes.
Quad nodes
- Query backlog or unresolved discrepancies
- Source verification or vendor delay
- Missingness in critical fields
- Governance lock or submission deadline
Input
One vignette.
Output
Strict JSON only.
Required keys
- lock_readiness_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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