Monitoring report redaction is the removal of subject and staff identifiers from a visit write-up. It supports ICH E6(R2) good clinical practice. anonym.plus runs offline and keeps the findings and actions readable.
When this applies
A CRA shares a visit report with the sponsor's wider team. The write-up names the subjects checked, the staff met, and the site.
How anonym.plus handles it
- Open the visit report (DOCX or PDF) in anonym.plus on your device.
- The tool scans for subject codes, staff names, and dates.
- Local OCR reads any scanned source-data extract.
- Confirm the flagged people and the site detail.
- Redact them, or swap each for a neutral role label.
- Save the cleaned write-up locally with no upload.
What you need to provide
- The visit report (DOCX, PDF, or scan).
- An operator: Redact for the audit file, Replace for circulation.
- Optional: a role map so one CRA maps to one label.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Staff | PERSON | CRA Helena Vogt → [MONITOR] |
| Subject code | ID | subject S-12-008 → [SUBJECT] |
| Visit date | DATE_TIME | visit 18 Feb 2026 → [DATE] |
| Site | LOCATION | Site 12, Vienna → [SITE] |
| Coordinator | PERSON | SC Mark Lee → [COORDINATOR] |
| Contact | EMAIL_ADDRESS | site12@example.at → [EMAIL] |
Compliance achieved
- Helps meet ICH E6(R2) GCP monitoring duties.
- Stays offline, so the tool itself needs no BAA.
- On-device AES-256-GCM guards the working file.
- Supports GDPR Art. 9 for EU subject and staff data.
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Limitations & cautions
A visit write-up often quotes a finding tied to one subject code. The tool hides names and codes, but a unique source-data issue can still point to a person at a small site. Review such findings before wide release.
Frequently asked questions
What is a monitoring visit report?
It is the CRA's record of a site visit: what was checked, what was found, and what must be fixed. It names subjects and staff. A redacted copy lets the wider team see findings without those names.
Will the findings stay clear?
Yes. The issues, the actions, and the deadlines stay. Only names, subject codes, and the site identity are redacted.
Can I keep an unredacted master?
Yes. Work on a copy. The source report stays on your device, untouched, for your own audit trail.