Definition

Prospective, organized collection of data on pregnancy outcomes following exposure to a drug; used for risk characterization and RMP (GVP Module V, XVI).

Example

Company-sponsored registry for women exposed to drug X during pregnancy.

Regulatory source

GVP Module V, XVI; FDA pregnancy registries

Common mistakes

Confusing registry with passive spontaneous reporting only.

Inspector question

How do you use pregnancy registries in your risk management?

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