lexiara

anx_I__cpt_4__point_20__point_a__text_1

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

eliciting and recording adverse events by the investigator, and the reporting of relevant adverse events by the investigator to the sponsor;

· All articles ·

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