CRO PlatformAI-Native CRO OS
Toggle navigationMenu

#12-rbqm-analytics

RBQM Analytics / CSM Dashboard

Clinical Monitoring (RBQM)

A2Phase 3Idle
Human gate role
CSM Lead
Purpose
Deterministic site rankings and global quality index; model only for narrative summaries.

Regulatory Dossier

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

Not production-ready
#12-rbqm-analyticsA2Clinical Monitoring (RBQM)High risk
Human gate role
CSM Lead
Model registry version
unpinned
SOP version
SOP-12-v1.3
Last validated
never validated
Unknown

Credibility evidence

  • Autonomy A2 — supervised agentic with human review + sign gate.
  • 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.

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
Clinical Monitoring (RBQM)
Autonomy
A2
Golden cases
≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/12-rbqm-analytics/golden.yaml.