9. References: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

1. Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014

2. Regulation (EU) No 536/2014 - Questions & Answers

3. Guideline for good clinical practice - ICH E6(R2) - EMA/CHMP/ICH/135/1995

4. ICH Topic E 3 Structure and Content of Clinical Study Reports (NOTE FOR GUIDANCE ON STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS (CPMP/ICH/137/95))

5. ICH guideline E3 - Questions & Answers (R1) - EMA/CHMP/ICH/435606/2012

© European Medicines Agency, 2021

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