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.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Patient | PERSON | patient F. Costa, 73 → [PATIENT] |
| Reporter | PERSON | Dr. Mendes (reporter) → [REPORTER] |
| Onset | DATE_TIME | hospitalised 09 Apr 2026 → [DATE] |
| Site | ORGANIZATION | São Paulo General → [FACILITY] |
| Age | AGE | 73 years → [AGE] |
| Contact | PHONE_NUMBER | +55 11 5555 0140 → [PHONE] |
Compliance achieved
- Supports privacy in ICH E2B(R3) serious-case handling.
- No cloud step, so the case stays inside your unit and needs no BAA.
- On-device AES-256-GCM guards the working form.
- Aligns with GDPR Art. 9 for EU case reports.
Anonymize 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?
It counts as serious if it causes death, a hospital stay, lasting harm, or a birth defect, among others. These cases are reported fast in the E2B(R3) format. A redacted copy protects the person during review.
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.