Study report anonymisation is the removal of patient identifiers from the document and its appendices. It supports MHRA clinical-trial transparency and ICH E6(R2). anonym.plus runs offline and keeps the results narrative readable.
When this applies
A sponsor must share the report after approval. Subject 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.
Patient data 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, Glasgow → [CENTRE] |
| Investigator | PERSON | Dr. Campbell → [INVESTIGATOR] |
| Contact | EMAIL_ADDRESS | site04@example.co.uk → [EMAIL] |
| NHS number | MEDICAL_RECORD_NUMBER | NHS 943 476 5919 → [NHS_NO] |
Compliance achieved
- Preserves the report structure ICH E3 sets out, so the shared CSR still reads as a regulatory document.
- Targets the appendices where identifiers concentrate: individual participant data listings at ICH E3 §16.2 and the case report forms for deaths, other serious adverse events and withdrawals at §16.3.
- Supports the summary-results publication the HRA's Make it Public strategy expects within 12 months of the end of the trial.
- A CSR only leaves UK GDPR scope once Recital 26 is met — no participant identifiable by any means reasonably likely to be used.
- Runs offline — no cloud upload, no data-processor contract; working copies stay under AES-256-GCM.
Anonymise clinical study reports offline — see plans & start free →
Limitations & cautions
The appendices are where the risk lives. Patient listings and case narratives hold the most direct identifiers. The tool scans them, but MHRA transparency 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, structured to ICH E3 and filed with the MHRA. Appendix 16.2 holds individual participant data listings and 16.3 the case report forms for deaths, other serious adverse events and withdrawals — that is where the identifiers sit, and where anonymisation has to start.
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.