19.

With regard to the notification of adverse events, the protocol shall identify the categories of: adverse events or laboratory anomalies that are critical to safety evaluations and must be reported by the investigator to the sponsor, and serious adverse events which do not require immediate reporting by the investigator to the sponsor.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.