This control plane turns synthetic clinical-event narratives into one review surface: chronology quality, seriousness framing, causality language, follow-up closure, physician addenda, and submission readiness before medical review hardens around weak packets.
| Risk | Owner | Subject | Observed state |
|---|---|---|---|
| high Narrative Intake |
Case Processing | Initial case narrative completeness | Two neurologic cases still lack a coherent onset timeline and one reporter summary contradicts the structured event date. |
| high Seriousness Summary |
Medical Review | Seriousness and hospitalization framing | One packet still buries the overnight hospitalization detail in free text and the seriousness summary is not aligned. |
| medium Causality Framing |
Drug Safety Science | Narrative causality explanation | The hepatic narrative packet still lacks a clean causality summary tying lab drift to product exposure timing. |
| medium Follow-Up |
Patient Safety | Reporter follow-up narrative closure | Two pediatric narratives still need outcome follow-up to close the open rash progression questions. |
| high Medical Review |
Safety Physician | Safety physician packet | The current neurologic packet still lacks the physician addendum explaining seizure chronology and escalation rationale. |
| high Submission Packet |
Regulatory Affairs | Submission-ready narrative packet | The hepatic packet still needs the reconciled literature citation and the final submission-ready narrative revision. |