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.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Subject Anna Berg → [SUBJECT_1] |
| Visit dates | DATE_TIME | Visit 2: 14/04/2026 → [DATE] |
| Site contact | PHONE_NUMBER | +44 20 7946 0210 → [PHONE] |
| Site location | LOCATION | Site 07, Leeds → [SITE] |
| Investigator | PERSON | PI Dr. Halloran → [INVESTIGATOR] |
| Local ID | MEDICAL_RECORD_NUMBER | Hospital no. 55120 → [LOCAL_ID] |
Compliance achieved
- Helps meet ICH E6(R2) GCP rules on subject privacy.
- Runs offline, so the tool itself needs no BAA.
- Working files are kept safe with AES-256-GCM.
- Handles GDPR Art. 9 health data for EU subjects too.
Anonymize 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, paper or electronic. GCP requires the sponsor to protect confidentiality. De-identifying a copy lets you share entries for review without exposing who took part.
Does this need a BAA?
No. anonym.plus runs on your own device with no cloud step. No outside party touches the subject data, so the tool itself needs no BAA.
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.