Investigator brochure PHI removal is the deletion of patient case details that slip into the document. It supports ICH E6(R2) good clinical practice. anonym.plus runs offline and keeps the safety and efficacy summary whole.
When this applies
A medical writer reuses a brochure across sites. Early case examples still carry a real patient's age, dates, and a clinic name.
How anonym.plus handles it
- Open the brochure (PDF or DOCX) in anonym.plus on your workstation.
- The tool scans the case sections for names, ages, and dates.
- Local OCR reads any figure or scanned appendix.
- Confirm the flagged patient details inside the examples.
- Replace them with neutral labels, or remove them.
- Save the cleaned document on your device.
What you need to provide
- The brochure (PDF, DOCX, or scan).
- An operator: Replace keeps the example readable.
- Optional: a label map for consistent case names.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Patient | PERSON | a 46-year-old, L. Ferreira → [CASE_PATIENT] |
| Age | AGE | 46-year-old → [AGE] |
| Dates | DATE_TIME | treated Q1 2025 → [PERIOD] |
| Clinic | ORGANIZATION | Porto Day Unit → [CENTRE] |
| Clinician | PERSON | Dr. Sousa → [CLINICIAN] |
| EMAIL_ADDRESS | trials@example.pt → [EMAIL] |
Compliance achieved
- Helps meet ICH E6(R2) GCP confidentiality duties.
- Stays offline, so the tool itself needs no BAA.
- On-device AES-256-GCM protects the working copy.
- Aligns with GDPR Art. 9 for any EU case detail.
Anonymize investigator brochures offline — see plans & start free →
Limitations & cautions
PHI in a brochure tends to hide in early case examples and figure captions. The tool scans both, but a number baked into an image chart may need a manual redaction box. Review figures by eye before you circulate the file.
Frequently asked questions
Why would a brochure hold PHI?
Early-phase examples sometimes quote a real case with an age, a date, or a centre. GCP expects that detail to be handled with care. Removing it lets the brochure travel between sites safely.
Does the drug data stay?
Yes. Pharmacology, dosing, and the safety summary stay untouched. Only the personal case details are swapped or removed.
Can it read text inside figures?
Local OCR reads visible text in images and captions. Numbers drawn into a chart graphic may still need a manual redaction box.