Phase 3 — Safety, protocol, RBQM, medical writing
Add the agents that drive medical and safety decisions, plus the protocol intake and the risk-based quality management wave. AI never makes the causality call.
| Workstream | Status | Shipped |
|---|---|---|
Safety / Pharmacovigilance cluster agents/15-safety-intake, agents/16-narrative-drafting, agents/17-signal-detection. Causality assessment remains a human-only act — enforced architecturally in packages/policy. Agents: 15-safety-intake, 16-narrative-drafting, 17-signal-detection | planned | — |
Protocol intake agent agents/00-protocol-intake — parses sponsor-supplied protocols, extracts structured study parameters, and seeds the rest of the agent cluster. Agents: 00-protocol-intake | planned | — |
RBQM wave agents/12-risk-assessment, agents/13-quality-tolerance-limits, agents/14-central-monitoring — risk register, QTL drift detection, central-monitoring triage. Agents: 12-risk-assessment, 13-quality-tolerance-limits, 14-central-monitoring | planned | — |
Medical writing cluster agents/20-csr-drafting, agents/21-publication-support — citation-grounded section drafting for CSRs and manuscripts. A2 supervised across the board. Agents: 20-csr-drafting, 21-publication-support | planned | — |