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.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Staff | PERSON | CRA Helen Davies → [MONITOR] |
| Subject code | ID | subject S-12-008 → [SUBJECT] |
| Visit date | DATE_TIME | visit 18 Feb 2026 → [DATE] |
| Site | LOCATION | Site 12, Oxford → [SITE] |
| Coordinator | PERSON | SC Mark Lee → [COORDINATOR] |
| Contact | EMAIL_ADDRESS | site12@example.co.uk → [EMAIL] |
Compliance achieved
- Keeps the monitoring-report content ICH E6(R2) §5.18.6 requires the monitor to give the sponsor after each visit — what was reviewed, findings, deviations, and actions agreed.
- Sponsor monitoring is itself a GCP duty under ICH E6(R2) §5.18, given legal force in the UK by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031).
- Subject codes quoted in findings stay pseudonymous, not anonymous, data — UK GDPR Art. 4(5).
- Named site staff are data subjects too; their details need a lawful basis under UK GDPR Art. 6(1), separate from the participants' Art. 9 route.
- Runs offline — no cloud upload, no data-processor contract; working copies stay under AES-256-GCM.
Anonymise trial monitoring reports offline — see plans & start free →
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.