Definition

Process of removing or encoding personal data in ICSRs so that the individual cannot be identified, while retaining data needed for pharmacovigilance (GVP VI Addendum II).

Example

Replacing initials with pseudonym, date of birth with age range.

Regulatory source

EMA GVP Module VI Addendum II (July 2025), GDPR Art 89

Common mistakes

Leaving indirect identifiers that could enable re-identification.

Inspector question

Describe your anonymization methodology and how you verify it.

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