Field-report anonymisation is the removal of patient and reporter IDs from a representative’s note from the field. A report reaching any company personnel counts as a spontaneous report the marketing authorisation holder must capture under Part 11 of the Human Medicines Regulations 2012. anonym.plus runs locally and keeps the product and the event, so the safety signal stays whole.
When this applies
A representative’s note logs a spontaneous report, naming the subject and the reporting clinician. The 15-day clock for a serious case starts the day the company first knows of it, so intake cannot wait on a slow manual redaction.
How anonym.plus handles it
- Open the note in anonym.plus on your device.
- It scans the free text for the named people.
- Dates, contacts, and sites get flagged in the entry.
- Confirm the flags; the product and event stay as non-IDs.
- Swap the IDs with steady labels for intake.
- Save the clean copy; the source stays on your machine.
What you need to provide
- The note (DOCX, PDF, TXT, or app export).
- Replace with a steady label map for intake.
- Optional reporter map for blinded handling.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Margaret Flynn → [PATIENT] |
| Names | PERSON | reporting nurse → [REPORTER] |
| Dates | DATE_TIME | noted 11 Apr → [DATE] |
| Contact | PHONE_NUMBER | +44 151 555 7781 → [PHONE] |
| Location | LOCATION | Birmingham clinic → [SITE] |
| Identifiers | ID | visit ref 220914 → [ID] |
Compliance achieved
- A report reaching company personnel is a spontaneous report the holder must capture under Part 11 of the Human Medicines Regulations 2012 and GVP Module VI.
- Serious cases go to the MHRA within 15 days of the day the company first knew of them, so intake cannot wait on a manual redaction pass.
- Structured intake still follows ICH E2B(R3); the product and the event are never touched.
- The processing gateway is UK GDPR Art. 9(2)(i) with DPA 2018 Schedule 1, Part 1, paragraph 3 — safety of medicinal products.
Anonymise field reports offline — see plans & start free →
Limitations & cautions
A representative’s note is quick free text with mixed clues. The product must stay, as it carries the signal. De-identifying the copy does not stop or reset the 15-day reporting clock, and it does not remove the duty to pass the case to safety intake. A rare event plus a small site can still narrow identity, so review unusual cases.
Frequently asked questions
Is the product name removed?
No. The product is not patient data and carries the safety signal, so it stays. Only the patient and reporter IDs are taken out.
Does anonymising delay my reporting duty?
No, and it must not. A serious case still reaches the MHRA within 15 days of the day your company first knew of it. Clean the copy you circulate, not the intake record.
Are reporter details personal data?
Yes. The reporter is often a clinician rather than the subject, but their name and contact details are still personal data, so many teams blind them for internal handling.