Safety-narrative de-identification is the removal of patient and reporter IDs from the free-text event story. It supports ICH E2B(R3). anonym.plus runs locally and keeps the suspected product and the timeline of the event.
When this applies
An event story is dense free text. It names the subject, the reporter, and places. To submit or pool it, you clear those IDs but keep the product and timeline.
How anonym.plus handles it
- Open the narrative in anonym.plus on your device.
- It reads the free text for the named people.
- Dates, ages, and places get flagged across the story.
- Confirm the flags; the suspected product stays as non-personal data.
- Swap the IDs and shift the dates to keep the gaps.
- Save the clean file; the source stays on your machine.
What you need to provide
- The narrative (DOCX, PDF, TXT, or export).
- A date-shift option to keep the event timeline.
- Replace with a steady label map for pooled work.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Niamh Walsh → [PATIENT] |
| Names | PERSON | reporting GP → [REPORTER] |
| Dates | DATE_TIME | dose 09 Feb → shifted [DATE] |
| Age | AGE | age 81 → [AGE_BAND] |
| Location | LOCATION | Bristol site → [SITE] |
| Identifiers | ID | narrative ref 5521 → [ID] |
Compliance achieved
- Supports ICH E2B(R3) safety case reporting.
- Keeps the suspected product, since it is not patient data.
- Date-shift keeps the event timeline; nothing is uploaded.
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Limitations & cautions
The story is free text with mixed clues. The suspected product must stay, as it is the signal. A rare event on a known date at a small site can still narrow identity, so band the age and shift dates for unusual cases.
Frequently asked questions
Is the suspected product removed?
No. The product name is not patient data and carries the safety signal, so it stays. Only the patient and reporter IDs are taken out.
How is the timeline kept useful?
Date-shift moves all dates by one steady offset, so the gaps between dose and event stay while the real dates are hidden.
Can narratives be pooled for signal work?
Yes. A steady label map lets one subject or reporter map to one alias across many files.