#07-site-monitoring
Site Monitoring & Visit Planning
Clinical Monitoring (RBQM)
A2Phase 3Idle
Regulatory Dossier
Identity, controls, risk, and credibility evidence — the page an FDA inspector reviews first.
#07-site-monitoringA2Clinical Monitoring (RBQM)High risk
Human gate role
CRA Manager
Model registry version
unpinned
SOP version
SOP-07-v1.3
Last validated
never validated
UnknownCredibility 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 2)
| Entity | State | Created | Signature |
|---|---|---|---|
| site_visit_plan 7ee5c44f-c863-4b5e-b7c6-6b4b66f2cd61 | reviewing | 99d ago | — |
| site_visit_plan e710709a-fbee-43db-9784-7b8b8f4666b8 | promoted | 99d ago | — |
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/07-site-monitoring/golden.yaml.