Audit Log
8 entries shown · Helix Therapeutics - Production · Retention: 10 years
| Timestamp | Agent | Tool | Decision | Outcome | Regulation | Actions |
|---|---|---|---|---|---|---|
| 2026-05-30 16:42:11 UTC | Emsah | engagement.evaluate | Dr. Maria Schmidt - Advisory Board €1,800 | Approved | EFPIA-DE | View narrative |
| 2026-05-30 15:58:02 UTC | Relay | ae.detect | Severe neutropenia - Dr. Ahmed Hassan | Detected | ICH E2A | Hide narrative |
AI narrativeGenerated by Lokatial AI· lokatial-pv-v3.0· 15:58:02On 2026-05-30 at 15:58 UTC, Lokatial Relay detected a serious unexpected adverse event from Dr. Ahmed Hassan (Oncologist, Munich). A 62-year-old female patient on Helix Drug X developed severe neutropenia (ANC 0.3) after the third cycle, resulting in hospitalization. The event was classified per ICH E2A as SERIOUS (hospitalization), UNEXPECTED (not in current Helix Drug X safety profile), SEVERE, with PROBABLE causality. PHI was tokenized before any downstream routing. An ICSR draft (ICH E2B(R3)) was generated and routed to Oracle Argus Safety, receiving case ID AR-2026-0934. The FDA 15-day expedited reporting clock has started. Helix Drug Safety team has been notified for human review; HCP-facing response is held pending PV specialist sign-off. Rule trace
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| 2026-05-28 14:23:09 UTC | Emsah | content.precheck | Outbound message to Dr. Friedrich Müller - comparative claim | Flagged | FDA OPDP | View narrative |
| 2026-05-28 11:02:44 UTC | Emsah | hcp.verify | Dr. Elena Conti - Italian license verification | Approved | EFPIA-DE | View narrative |
| 2026-05-28 10:11:30 UTC | Emsah | fmv.calculate | Speaker program - Dr. Søren Nielsen - €1,600 | Approved | EFPIA-DE | View narrative |
| 2026-05-27 17:48:01 UTC | Emsah | engagement.evaluate | Dr. Priya Patel - Speaker Program €2,200 | Blocked | Customer Internal | View narrative |
| 2026-05-27 14:30:22 UTC | Relay | medinfo.respond | Off-label inquiry - Dr. Hassan - routed to MedInfo | Approved | FDA OPDP | View narrative |
| 2026-05-27 09:14:08 UTC | Emsah | disclosure.draft | Q3 EFPIA-DE disclosure draft | Approved | EFPIA-DE | View narrative |