Follow one safety report, from the first email to a regulator-ready assessment
A hospital pharmacist emails about a patient admitted after a first dose. Here is how the life sciences pack and the safety team handle it. All names and data are fictional.
Step by step
- 01 · Day 1 · Received
An email becomes a draft case.
A hospital pharmacist writes about a patient admitted with very low blood pressure. A discharge letter is attached.
AI: read the email and the letter and drafted case ICSR-26-0912.Received by the safety inbox
halden · safety · ICSR-26-0912Sample dataNew reportICSR-26-0912Draft caseReceivedValidCodedSeriousNarrativeAssessedSealedFrom the email"Patient admitted on 4 Oct with severe hypotension, two days after first dose of HB-207." 1
1Email from reporter, 6 Oct, 08:40MAIL - 02 · Day 1 · Valid
Is it a valid case?
A case needs an identifiable patient, a reporter, a suspect product and an event. The pack checks each one and shows where it found it.
AI: found all four minimum criteria, each with its source.Checked by Tomás Ferreira, case processor
halden · safety · ICSR-26-0912Sample dataMinimum criteriaICSR-26-0912ValidReceivedValidCodedSeriousNarrativeAssessedSealedCriterion Found Where Patient Woman, 64 Letter, p. 1 Reporter Hospital pharmacist Email Product HB-207 Email, letter p. 2 Event Severe hypotension Letter, p. 2 - 03 · Day 1 · Coded
Terms coded, duplicates checked.
The pack codes the event and the medicines, and searches for the same case reported another way. It finds none.
AI: coded 1 event and 3 medicines, and found no duplicate.Tomás Ferreira: changed one code.Checked by Tomás Ferreira, case processor
halden · safety · ICSR-26-0912Sample dataCodingICSR-26-0912CodedReceivedValidCodedSeriousNarrativeAssessedSealedReported Coded as Change severe hypotension Hypotension — HB-207 Suspect product — two BP tablets Concomitant: 2 products Edited by Tomás Duplicate search: 0 matches in cases, partner feeds or literature.
- 04 · Day 1 · Serious
Serious, with the clock running.
Hospitalisation makes the case serious. The reporting clock starts from the day the report was received.
AI: marked the case serious and set the 15-day deadline.Confirmed by Tomás Ferreira, case processor
halden · safety · ICSR-26-0912Sample dataSeriousnessICSR-26-0912SeriousReceivedValidCodedSeriousNarrativeAssessedSealedWhy- Criterion
- Hospitalisation
- Source
- Discharge letter, p. 1
Deadline- Received
- 6 Oct
- Report due
- within 15 days
- Left
- 15 days
- 05 · Day 2 · Narrative
A narrative with a source for every sentence.
The pack drafts the case narrative from the facts. Every sentence links to the email or the letter.
AI: drafted the narrative, flagging that the dose was not stated.Tomás Ferreira: asked the reporter for the dose and added it.Drafted with Tomás Ferreira, case processor
halden · safety · ICSR-26-0912Sample dataNarrativeICSR-26-0912Ready for reviewReceivedValidCodedSeriousNarrativeAssessedSealedDraftA 64-year-old woman received her first dose of HB-207 on 2 Oct 1. On 4 Oct she was admitted with severe hypotension 2. She was taking two blood pressure medicines 2. She recovered after fluids and stopping one medicine 2.
1Email from reporterMAIL2Discharge letter, pp. 1–2PDF - 06 · Day 3 · Assessed
A medical reviewer judges causality.
Dr Ingrid Solheim reviews the narrative and the evidence, and decides the event is possibly related to HB-207.
Dr Ingrid Solheim: assessed causality as possible and wrote her reason.Decided by Dr Ingrid Solheim, medical reviewer
halden · safety · ICSR-26-0912Sample dataMedical reviewICSR-26-0912PossibleReceivedValidCodedSeriousNarrativeAssessedSealedAssessmentPlausible time to onset; other blood pressure medicines may have contributed. Causality: possible.
Sign assessmentSend back - 07 · Day 4 · Sealed
Submitted and sealed.
The case is submitted to the regulator's database four days after receipt, well inside the deadline. The whole case is sealed.
Tomás Ferreira: submitted the case.AI: sealed the record and its audit trail.Sealed at 09:22 · checkable with the open verifier
halden · safety · ICSR-26-0912Sample dataICSR-26-0912submittedSealedReceivedValidCodedSeriousNarrativeAssessedSealedsubmitted 10 Oct, day 4 of 15 assessed Dr Ingrid Solheim edits 3, all kept sources 2 documentsSealed 09:22:31 · timestamp witnessed outside Halden Bio
"Patient admitted on 4 Oct with severe hypotension, two days after first dose of HB-207." 1
| Criterion | Found | Where |
|---|---|---|
| Patient | Woman, 64 | Letter, p. 1 |
| Reporter | Hospital pharmacist | |
| Product | HB-207 | Email, letter p. 2 |
| Event | Severe hypotension | Letter, p. 2 |
| Reported | Coded as | Change |
|---|---|---|
| severe hypotension | Hypotension | — |
| HB-207 | Suspect product | — |
| two BP tablets | Concomitant: 2 products | Edited by Tomás |
Duplicate search: 0 matches in cases, partner feeds or literature.
- Criterion
- Hospitalisation
- Source
- Discharge letter, p. 1
- Received
- 6 Oct
- Report due
- within 15 days
- Left
- 15 days
A 64-year-old woman received her first dose of HB-207 on 2 Oct 1. On 4 Oct she was admitted with severe hypotension 2. She was taking two blood pressure medicines 2. She recovered after fluids and stopping one medicine 2.
Plausible time to onset; other blood pressure medicines may have contributed. Causality: possible.
Every fact, every edit, every signature.
The source documents, the facts, the coding changes, the narrative, the assessment and the submission are in one sealed record, with the audit trail inspectors expect.
Change one word of a sealed record and the check fails. Try the seal check →
The AI read and drafted. Experts decided.
Here is the split, step by step.
What the AI did
- Read the email and the discharge letter and drafted the case
- Checked the four minimum criteria, with sources
- Coded the terms and searched for duplicates
- Set the 15-day deadline
- Drafted the narrative and flagged the missing dose
- Sealed the record and its audit trail
What people decided
- Tomás Ferreira corrected one code and asked the reporter for the dose
- Dr Ingrid Solheim assessed causality as possible
- Tomás Ferreira submitted the case
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