Case report form de-identification is the removal of subject identifiers from the file. It supports ICH E6(R2) good clinical practice. anonym.plus does this on your own device, so the recorded values still read as written.
When this applies
A monitor or sponsor needs to view a completed form without seeing who took part. The name, site, and visit dates must go first.
How anonym.plus handles it
- Open the form (PDF, DOCX, or scan) in anonym.plus on your device.
- Local OCR reads scanned pages, so printed entries are caught too.
- The tool flags names, dates, site codes, and contacts.
- Review each flag and keep clinical measurements untouched.
- Swap each identifier for a steady label, or black it out.
- Save the clean copy. The source never leaves your machine.
What you need to provide
- The form (PDF, DOCX, TXT, or image scan).
- An operator: Replace (swap), Redact (remove), or Mask (partial).
- Optional: a map if you must re-link entries later.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Subject Alice Hartley → [SUBJECT_1] |
| Visit dates | DATE_TIME | Visit 2: 14/04/2026 → [DATE] |
| Site contact | PHONE_NUMBER | +44 113 496 0210 → [PHONE] |
| Site location | LOCATION | Site 07, Leeds → [SITE] |
| Investigator | PERSON | PI Dr. Patel → [INVESTIGATOR] |
| NHS number | MEDICAL_RECORD_NUMBER | NHS 943 476 5919 → [LOCAL_ID] |
Compliance achieved
- Meets the confidentiality principle in ICH E6(R2) §2.11 — records that could identify a subject must be protected.
- GCP binds UK trials through the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), whose schedules carry the conditions and principles of good clinical practice.
- Leaves intact the CRF accuracy and completeness the investigator owes the sponsor under ICH E6(R2) §4.9.1.
- Health entries are special category under UK GDPR Art. 9(1); research reuse runs on Art. 9(2)(j) with the DPA 2018 Sch. 1 Pt. 1 para. 4 research condition.
- Runs offline — no cloud upload, no data-processor contract; working copies stay under AES-256-GCM.
Anonymise case report forms offline — see plans & start free →
Limitations & cautions
A code (like S-07-014) can still link back through the master log. The tool hides direct names and contacts. You decide whether the trial code itself must also go before you share it widely.
Frequently asked questions
What is a case report form under ICH E6?
It is the record of each participant’s trial data, on paper or electronic. ICH E6(R2) §4.9.1 makes the investigator responsible for its accuracy and completeness, and §2.11 requires records that could identify a subject to be protected. De-identifying a copy lets you share entries for review without exposing who took part.
Is a data-processor contract needed?
No. anonym.plus runs fully on your own device with no cloud step. No outside party touches the subject data, so no data-processor agreement is triggered.
Will the recorded values still make sense?
Yes. Only names, dates, and site codes change. Lab values, doses, and outcomes stay as entered, so a reviewer reads the same clinical picture.