ADR anonymisation is the removal of patient and reporter IDs from a reaction write-up. The MHRA Yellow Card scheme has gathered suspected reactions since 1964, and Part 11 of the Human Medicines Regulations 2012 now carries the duty. anonym.plus runs on your device and keeps the suspected medicine and the reaction intact.
When this applies
A reaction write-up holds the person, whoever reported it, and contact lines. To pool it for signal work under GVP Module IX, you need one steady alias per subject rather than a real name — and the medicine and event untouched.
How anonym.plus handles it
- Load the write-up into anonym.plus on your device.
- It finds the named people in the free text.
- Dates, ages, and contacts get flagged across the entry.
- Confirm the flags; the suspected medicine stays as non-personal data.
- Swap the IDs with steady labels for pooled work.
- Save the clean file on your machine with no upload.
What you need to provide
- The write-up (DOCX, PDF, TXT, or export).
- Replace with a steady label map for pooled signals.
- Optional banding for the year-of-birth field.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | James Okafor → [PATIENT] |
| Names | PERSON | nurse reporter → [REPORTER] |
| Age | AGE | age 73 → [AGE_BAND] |
| Dates | DATE_TIME | reaction 11 Apr → [DATE] |
| Contact | PHONE_NUMBER | +44 30 555 7781 → [PHONE] |
| Identifiers | ID | ICSR 4471 → [ID] |
Compliance achieved
- Feeds the MHRA Yellow Card scheme, running since 1964 and now carried by Part 11 of the Human Medicines Regulations 2012.
- Keeps reports poolable for GVP Module IX signal management, where one steady alias per subject matters more than a real name.
- Structured transfer still follows ICH E2B(R3); only the patient and reporter identifiers are cleared, never the reaction terms.
- Banding an age above 89 answers the small-group re-identification risk the ICO anonymisation guidance flags under the motivated-intruder test.
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Limitations & cautions
Exact age can identify in older people, so band it where your study allows. The suspected medicine stays, as it holds the signal. Anonymising a copy does not change your reporting clock: serious cases still go to the MHRA within 15 days of the day your organisation first knew of them. A rare event plus a small site can still narrow identity even after direct IDs are removed.
Frequently asked questions
Why keep the suspected medicine name?
The product is not personal data and is the heart of the signal. Removing it would gut the report. Only the IDs of the named people are taken out.
How is the subject's age handled?
Age is a strong clue, above all over 89, where the ICO anonymisation guidance treats the group as small enough to single someone out. The tool flags it so you can band it into a decade where your analysis allows.
Can reports be pooled afterwards?
Yes. A steady label map lets one person map to one alias across many files, which is what GVP Module IX signal detection needs to spot a repeat case.