Definition

Any information relating to an identified or identifiable natural person in an ICSR (e.g., name, DOB, address, identifiers). Subject to GDPR and local laws; masking required for EU submission.

Example

Patient initials and exact DOB are personal data; age range and sex may be permissible in context.

Regulatory source

GDPR Art 4(1), GVP Module VI Addendum II

Common mistakes

Treating all patient fields as non-personal data.

Inspector question

How do you classify and protect personal data in your ICSR workflow?

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