Study report anonymization is the removal of patient identifiers from the document and its appendices. It supports EMA Policy 0070 on data publication. anonym.plus runs offline and keeps the results narrative readable.
When this applies
A sponsor must publish the report after approval. Patient listings and case narratives in the appendices still carry names and dates.
How anonym.plus handles it
- Open the document (PDF or DOCX) in anonym.plus on your machine.
- The tool scans the body and appendices for direct identifiers.
- Local OCR reads any scanned listing or signature page.
- Confirm the flagged names, dates, and centre codes.
- Replace each with a steady token across the whole file.
- Save the cleaned version locally with no upload.
What you need to provide
- The document (PDF, DOCX, or scan).
- An operator: Replace for tokens, Redact for whole listings.
- Optional: a token map for consistent labels across volumes.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Patient | PERSON | patient 04-118, K. Novak → [PATIENT_4] |
| Dates | DATE_TIME | discontinued 03/2026 → [DATE] |
| Centre | LOCATION | Centre 04, Prague → [CENTRE] |
| Investigator | PERSON | Dr. Dvorak → [INVESTIGATOR] |
| Contact | EMAIL_ADDRESS | site04@example.cz → [EMAIL] |
| Age | AGE | aged 88 → [AGE_BAND] |
Compliance achieved
- Supports public release under EMA Policy 0070.
- Stays offline, so no BAA or transfer step is needed.
- On-device AES-256-GCM protects the working copy.
- Aligns with GDPR Recital 26 when the result no longer identifies anyone.
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Limitations & cautions
The appendices are where the risk lives. Patient listings and case narratives hold the most direct identifiers. The tool scans them, but Policy 0070 also wants a documented risk assessment of rare values before you publish.
Frequently asked questions
What is a clinical study report?
It is the full account of a trial's design, conduct, and results, filed with regulators. After approval, EMA may publish it. The appendices carry patient-level detail that must be anonymised first.
Which part needs the most attention?
The appendices. Patient listings and individual case narratives hold names, dates, and centre codes. The body text usually holds aggregate figures only.
Will the results still read clearly?
Yes. Efficacy and safety tables stay. Only direct identifiers in listings and narratives are swapped for steady tokens.