GDPR, ICSR masking, anonymization, and data protection in PV (GVP VI Addendum II, CDSCO).
21 terms
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).
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.
Processing of personal data so that it can no longer be attributed to a specific person without use of additional information kept separately (GDPR Art 4(5)).
EU General Data Protection Regulation; PV activities may rely on legal basis such as public interest or legal obligation. Data minimization and purpose limitation apply.