Definition

Systematic follow-up of reported pregnancies in which the suspect drug was used, to collect outcome data (live birth, miscarriage, congenital anomaly, etc.).

Example

Follow-up at 6–12 months to obtain birth outcome and infant health.

Regulatory source

GVP Module VI, XVI; ICH E2D(R1)

Common mistakes

Not attempting follow-up or closing case before outcome known.

Inspector question

What is your process and timeline for pregnancy case follow-up?

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