20.

The protocol shall describe the procedures for: eliciting and recording adverse events by the investigator, and the reporting of relevant adverse events by the investigator to the sponsor; reporting by the investigator to the sponsor of those serious adverse events which have been identified in the protocol as not requiring immediate reporting; reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database; and follow-up of subjects after adverse reactions including the type and duration of follow-up.

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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.