2.3. Information for the reporting of SUSARs

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

The information shall at least include: a valid EU trial number; a sponsor study number; an identifiable coded subject; an identifiable reporter; a SUSAR; a suspect investigational medicinal product (including active substance name-code); a causality assessment. In addition, in order to properly process the report electronically, the following administrative information shall be provided: the sender's (case) safety report unique identifier; the receive date of the initial information from the primary source; the receipt date of the most recent information; the worldwide unique case identification number; the sender identifier.

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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.