SAE report redaction is the removal of patient and reporter identifiers from a serious-event form. It supports ICH E2B(R3) safety reporting. anonym.plus runs offline and keeps the case facts and timeline readable.
When this applies
A safety unit forwards the form to a board for review. It names the affected person, the reporter, and the treating site.
How anonym.plus handles it
- Open the form (PDF, DOCX, or scan) in anonym.plus on your device.
- Local OCR reads scanned or faxed pages too.
- The tool flags the affected person, reporter, and site.
- Confirm the flags and keep the event and drug facts.
- Redact the personal fields, or swap them for labels.
- Save the cleaned form locally with no upload.
What you need to provide
- The form (PDF, DOCX, fax scan, or image).
- An operator: Redact for the board file, Replace for tokens.
- Optional: a label map for repeated reporters.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Patient | PERSON | patient F. Clarke, 73 → [PATIENT] |
| Reporter | PERSON | Dr. Evans (reporter) → [REPORTER] |
| Onset | DATE_TIME | hospitalised 09 Apr 2026 → [DATE] |
| Site | ORGANIZATION | Royal London Hospital → [FACILITY] |
| Age | AGE | 73 years → [AGE] |
| Contact | PHONE_NUMBER | +44 20 7946 0140 → [PHONE] |
Compliance achieved
- Keeps the seriousness criteria from ICH E2A visible — death, life-threatening event, hospitalisation or its prolongation, persistent disability, congenital anomaly.
- Preserves the ICSR data elements ICH E2B(R3) defines, so the case can still be transmitted to the MHRA.
- Supports the expedited clock the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) set for suspected unexpected serious adverse reactions: 7 days for fatal or life-threatening reactions, 15 days for other SUSARs.
- Safety processing has its own special-category condition — UK GDPR Art. 9(2)(i), quality and safety of medicinal products, with DPA 2018 Sch. 1 Pt. 1 para. 3.
- No cloud step — the case stays inside your unit, encrypted at rest with AES-256-GCM.
Anonymise serious adverse event reports offline — see plans & start free →
Limitations & cautions
A serious event with a rare drug pairing can still suggest one person at a known site. The tool hides direct identifiers. You judge whether an unusual clinical combination needs more care before the board sees the form.
Frequently asked questions
What makes an adverse event serious?
Under the ICH E2A criteria an event is serious if it results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent disability, or is a congenital anomaly. Suspected unexpected serious adverse reactions go to the MHRA in ICH E2B(R3) format on a 7-day clock when fatal or life-threatening, and 15 days otherwise. A redacted copy lets a board review the case without seeing who it was.
Can it read a faxed form?
Yes. Local OCR reads scanned and faxed pages, then flags the patient, reporter, and site fields for you to redact.
Do the event facts stay?
Yes. The reaction, the suspect drug, the dose, and the outcome stay. Only the people, the site, and exact dates are removed.