Informed consent anonymisation is the removal of the signer’s personal details from the page. It supports ICH E6(R2) good clinical practice. anonym.plus runs offline, so the agreement text stays whole while the names go.
When this applies
An auditor wants to confirm the consent wording, not who signed. The signed page holds names, dates, and a handwritten signature.
How anonym.plus handles it
- Open the signed page (PDF or scan) in anonym.plus on your device.
- Local OCR reads the printed and stamped fields on the scan.
- The tool flags the signer name, the date, and contact lines.
- Review the flags and keep the standard consent wording.
- Black out the signature block, or swap names for labels.
- Save the clean version locally with no upload.
What you need to provide
- The signed page (PDF, DOCX, or image scan).
- An operator: Redact for the signature, Replace for names.
- Optional: a label map if you track consent versions.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Signer | PERSON | Catherine Walsh → [SIGNER] |
| Sign date | DATE_TIME | signed 09/05/2026 → [DATE] |
| Witness | PERSON | witness R. Khan → [WITNESS] |
| Address | LOCATION | 12 Meadow Lane, Bristol → [ADDRESS] |
| Contact | PHONE_NUMBER | +44 117 496 0190 → [PHONE] |
| NHS number | MEDICAL_RECORD_NUMBER | NHS 485 777 3310 → [ID] |
Compliance achieved
- Leaves untouched the consent elements ICH E6(R2) §4.8 requires — purpose, risks, voluntariness, and the right to withdraw without penalty.
- Informed consent is mandated for UK trials by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), whose schedules set separate conditions for adults, minors and incapacitated adults.
- Where an adult lacks capacity, the research conditions in Mental Capacity Act 2005 ss.30–33 apply instead of ordinary consent.
- The signed page holds UK GDPR Art. 9(1) health data plus a signature; an auditor verifying wording against the version a research ethics committee approved under GAfREC needs neither.
- Runs offline — no cloud upload, no data-processor contract; working copies stay under AES-256-GCM.
Anonymise informed consent forms offline — see plans & start free →
Limitations & cautions
A handwritten signature can be hard for OCR to read as text. The tool can black out the whole signature box to be safe. Always check the scanned page by eye, since a faint stamp or initial may sit outside the detected zone.
Frequently asked questions
Why anonymise a consent form?
An auditor or research ethics committee usually needs to confirm that the wording matches the version approved and carries the elements ICH E6(R2) §4.8 requires — not who signed it. A clean copy proves the form was correct while keeping the signer’s Art. 9(1) health data out of the audit file.
Can it handle a handwritten signature?
Yes. The Redact operator blacks out the signature block as an image area, so it does not rely on reading the handwriting as text.
Does the legal wording change?
No. Only the personal fields change. The agreement language, the study name, and the rights statements stay exactly as written.