Adverse Drug Reaction Report Anonymisation with anonym.plus

Clear IDs from the ADR write-up while the reaction detail stays.

ADR anonymisation is the removal of patient and reporter IDs from a reaction write-up. It supports the MHRA Yellow Card scheme and ICH E2B(R3). 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, the one who reported it, and contact lines. To pool it for signal work, you clear the IDs but keep the medicine and event.

How anonym.plus handles it

  1. Load the write-up into anonym.plus on your device.
  2. It finds the named people in the free text.
  3. Dates, ages, and contacts get flagged across the entry.
  4. Confirm the flags; the suspected medicine stays as non-personal data.
  5. Swap the IDs with steady labels for pooled work.
  6. Save the clean file on your machine with no upload.

What you need to provide

Patient data entity types detected

Categoryanonym.plus entity typeExample
NamesPERSONJames Okafor → [PATIENT]
NamesPERSONnurse reporter → [REPORTER]
AgeAGEage 73 → [AGE_BAND]
DatesDATE_TIMEreaction 11 Apr → [DATE]
ContactPHONE_NUMBER+44 30 555 7781 → [PHONE]
IdentifiersIDICSR 4471 → [ID]

Compliance achieved

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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. 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 can be a clue, above all over 89. 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.