#20-protocol-authoring

Protocol Authoring

Medical Writing

A2Phase 4Idle

Human gate role

Medical Writer + Medical Officer (dual sign-off)

Purpose

Drafts protocols and amendments section-by-section per ICH M11 / E6(R3) / E8(R1).

Regulatory Dossier

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

Not production-ready

#20-protocol-authoringA2Medical WritingHigh riskDual-control gate

Human gate role

Medical Writer + Medical Officer (dual sign-off)

Model registry version

unpinned

SOP version

SOP-20-v1.4

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+).
Dual-control gate: Medical Writer + Medical Officer (dual sign-off).

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

Medical Writing

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/20-protocol-authoring/golden.yaml.