Definition

Policies and duration for retaining PV data (cases, source documents). Must align with regulatory requirements (e.g., post-authorization) and data protection law.

Example

Retain ICSRs and source documents for at least period required by regulation; then archive or anonymize.

Regulatory source

GVP Module I, GDPR, FDA 21 CFR 314.80

Common mistakes

Retaining indefinitely without legal basis or deletion schedule.

Inspector question

What is your retention period for ICSRs and how do you justify it?

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