QC & Handoff
Case PV-2026-0142 · Final QC, discrepancy resolution, and handoff package generation
QC Checklist
| Check | Description | Note | Status | Actions | |
|---|---|---|---|---|---|
| Source article attached | Full-text PDF of the source article is attached to the case record. | Reinholt_2026_cardiomab_DILI.pdf attached | ✓ Pass | ||
| Citation complete | Vancouver-style citation includes authors, title, journal, year, volume, pages. | Reinholt M, et al. J Hepatol. 2026;71(3):412–418. | ✓ Pass | ||
| Patients separated | Each identifiable patient in the article is split into a separate case. | Single patient in source — no split required. | ✓ Pass | ||
| Four minimum criteria reviewed | Identifiable patient, identifiable reporter, suspect product, and suspected reaction all reviewed by a human. | All four confirmed/edited in ICSR Workbench. | ✓ Pass | ||
| Product/event evidence confirmed | Source passages supporting product and event identification are linked and verified. | Page 3 ¶2 (product), Page 4 ¶1 (event). | ✓ Pass | ||
| Seriousness indicators reviewed | Seriousness criteria (hospitalisation, life-threatening, disability, etc.) reviewed and justified. | Hospitalisation 9 days — serious. | ✓ Pass | ||
| Day Zero confirmed | Human-confirmed Day Zero date with evidence and (if applicable) correction reason. | Awaiting reviewer confirmation in ICSR Workbench. | ⏳ Pending | ||
| Narrative source-supported | Every narrative sentence is traceable to a source passage; no invented dates, doses, or outcomes. | 2 flags (missing onset date, conflicting outcome) acknowledged. | ✓ Pass | ||
| Human corrections documented | All edits to AI-extracted fields are logged with reviewer identity and timestamp. | Audit trail shows 3 edits by reviewer TP. | ✓ Pass | ||
| Duplicate search completed | Case checked against existing safety database for duplicate patients/products. | Duplicate search not yet executed. | ⏳ Pending | ||
| Medical review completed | A qualified medical reviewer has reviewed the case narrative and seriousness assessment. | Medical reviewer sign-off pending. | ⏳ Pending | ||
| Audit history complete | End-to-end audit trail from search run → screening → workbench → QC is intact. | 12 audit entries, no gaps detected. | ✓ Pass |
AI Quality Agent — Discrepancy Panel
🤖 Quality AgentFindings are suggestions. They remain open until a QC reviewer accepts or rejects each one. Accepted findings flow into the QC record; rejected findings are logged with the rejection.
Structured data says 64-year-old woman; abstract mentions “female in her seventh decade” — consistent, but verify exact age.
Suggested action: Confirm age against full-text Page 3 ¶2.
Narrative states “Cardiomab 10mg” but Table 2 lists “10 mg/day” — unit formatting differs.
Suggested action: Standardise dose representation to “10 mg, oral, once daily.”
AI extracted an event date of 2026-05-30 but therapy start is reported as “six weeks prior” — chronology implies onset within exposure window, not before. Flagged for verification.
Suggested action: Remove inferred event date; mark as missing until source confirms exact onset.
Outcome field says “Recovering” but Discussion mentions “persistent cholestasis at 6-month follow-up” — outcome not fully resolved.
Suggested action: Set outcome to “Recovering/Not recovered” and add follow-up note.
Seriousness marked as “required/prolonged hospitalisation” but hospitalisation duration not explicitly stated as > limits — verify against local criteria.
Suggested action: Confirm hospitalisation duration (9 days) meets serious criteria threshold.
Narrative mentions “R-value >5” (interpretation) but structured reactions field lists only “Acute liver injury.”
Suggested action: Add “drug-induced liver injury (R-value >5)” to structured reactions.
Two case information fields (concomitant products, country) remain unconfirmed by the reviewer.
Suggested action: Return to ICSR Workbench and confirm or edit these fields.
Company comments field has no source citation — reviewer-entered text should note provenance.
Suggested action: Add citation or mark as internal company comment (non-sourced).
Handoff Package Generation
Structured literature case summary assembling: source article, citation, patient data, four-criteria assessment, draft narrative, seriousness indicators, Day Zero evidence, human review record, and QC record.
Safety System Integration
Integration placeholders for downstream safety databases. No regulatory submission is performed in this prototype — buttons only stage a package locally.