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SS-001
Quad safety signal analysis. Phase II trial. Liver enzyme elevations seen in 7% at Site A vs 2% network. AE reporting lag median 9 days at Site A. Conmed statin exposure undocumented in 15%. Data: baseline ALT missing in 11%. Governance: safety board review in 10 days. Determine if safety signal risk exists and action....
{"safety_signal_risk":true,"risk_type":"latent_signal_with_reporting_lag","driver_nodes":["elevated ALT rate at one site","AE reporting lag","undocumented statin exposure","missing baseline ALT and upcoming review"],"recommended_action":"rapid_signal_review","action_detail":["expedite AE entry at Site A","reconcile sta...
Signal plus lag plus confound.
SS-002
Quad safety signal analysis. Vaccine trial. Fever events cluster after Batch X. AE entries delayed 5 days. Conmed antipyretic use missing in 22%. Data: temperature logs incomplete. Governance: batch release decision pending. Determine risk and action. JSON only.
{"safety_signal_risk":true,"risk_type":"batch_signal_uncertainty","driver_nodes":["fever cluster by batch","AE entry delay","missing antipyretic data","batch release decision"],"recommended_action":"batch_hold_and_check","action_detail":["hold Batch X release","reconcile antipyretic use","complete temperature logs","an...
Batch decision is governance.
SS-003
Quad safety signal analysis. Oncology trial. Neutropenia rates higher at Site 5. Lab result upload lag 4 days. Conmed G-CSF use undocumented in 18%. Data: dosing delays not recorded. Governance: DSMB review in 2 weeks. Determine risk and action. JSON only.
{"safety_signal_risk":true,"risk_type":"confounded_neutropenia_signal","driver_nodes":["higher neutropenia rate","lab upload lag","missing G-CSF documentation","DSMB timing"],"recommended_action":"clarify_exposure","action_detail":["document G-CSF timing","clear lab upload backlog","capture dosing delays","brief DSMB o...
Exposure timing is key.
SS-004
Quad safety signal analysis. Cardiology trial. Hypotension events cluster at night. AE entries delayed until morning. Conmed antihypertensive dose changes missing. Data: nighttime BP logs incomplete. Governance: safety monitoring committee weekly call. Determine risk and action. JSON only.
{"safety_signal_risk":true,"risk_type":"time_of_day_signal_masking","driver_nodes":["night hypotension cluster","delayed AE entry","missing dose change data","incomplete BP logs and weekly review"],"recommended_action":"night_monitoring_fix","action_detail":["capture night BP logs reliably","record dose timing changes"...
Time-of-day confound.
SS-005
Quad safety signal analysis. GI trial. Bleeding events slightly elevated. AE seriousness grading inconsistent across sites. Conmed NSAID use recorded late. Data: hemoglobin baseline missing 9%. Governance: interim safety summary due in 3 weeks. Determine risk and action. JSON only.
{"safety_signal_risk":true,"risk_type":"grading_and_confound_mix","driver_nodes":["bleeding rate increase","inconsistent seriousness grading","late NSAID documentation","missing baseline Hb and interim deadline"],"recommended_action":"standardize_and_reconcile","action_detail":["standardize AE grading","reconcile NSAID...
Grading variance matters.
SS-006
Quad safety signal analysis. Neurology trial. Headache events rise after dose escalation. AE reporting lag 3 days. Conmed caffeine intake undocumented. Data: exact dose escalation times missing. Governance: escalation decision review in 1 week. Determine risk and action. JSON only.
{"safety_signal_risk":true,"risk_type":"dose_response_uncertainty","driver_nodes":["post-escalation headache rise","AE lag","undocumented caffeine","missing escalation timestamps and review"],"recommended_action":"dose_timing_repair","action_detail":["capture escalation timestamps","document caffeine intake","enter AEs...
Dose timing is core.

Clarus Clinical Quad Coupling Safety Signal Latency Reporting Lag Conmed Confound v0.1

What this dataset is
This dataset tests whether a model can detect latent safety signals when four interacting nodes create uncertainty.

Quad coupling nodes

  • Emerging safety event pattern
  • Reporting or entry latency
  • Concomitant medication or behavior confound
  • Governance decision timing such as DSMB, batch release, or safety review

Input

  • One vignette

Output
Return strict JSON only.

Required output JSON keys

  • safety_signal_risk
  • risk_type
  • driver_nodes
  • recommended_action
  • action_detail
  • rationale
  • confidence

Files

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

Scoring

  • Required key presence
  • Risk classification
  • Risk type match
  • Driver node overlap
  • Recommended action match
  • Action detail completeness
  • Rationale length
  • Confidence within 0 to 1

Run scoring
Create JSONL
{"id":"SS-T01","output":"{...your json...}"}

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

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