#19-trial-simulation

Trial Simulation

Biostatistics

A1Phase 2Idle

Human gate role

Statistician

Purpose

Sample-size estimation, adaptive-design simulation, scenario modeling — assistive only.

Regulatory Dossier

Identity, controls, risk, and credibility evidence — the page an FDA inspector reviews first.

Not production-ready

#19-trial-simulationA1BiostatisticsMedium risk

Human gate role

Statistician

Model registry version

unpinned

SOP version

SOP-19-v1.2

Last validated

never validated

Unknown

Credibility evidence

Autonomy A1 — assistive (human asks, human decides).
Agents write only to staging; promotion to live requires a Part 11 e-signature.
Every regulated action carries created_by, created_at, and provenance_id (ALCOA+).

References

Production readiness blockers

No validation runs recorded yet — golden dataset run required.
Model registry version is not pinned.

View full validation history →

Headline metrics (last 7 days)

Runs (24h)

—

Runs (7d)

—

Model-invoked (7d)

—

Signed (7d)

—

Last run

never

No runs recorded in the last 7 days for this agent.

Recent runs (last 0)

No provenance events recorded for this agent yet.

Recent staged records (last 0)

No staged records for this agent yet.

Golden dataset coverage

Cluster

Biostatistics

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/19-trial-simulation/golden.yaml.