Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation's entry into application.
A transition period applies to clinical trial submission under the Regulation.
Table of Contents
3. How to report a serious breach
4. Clarification on reporting requirements
5. Reporting serious breaches – Points to consider
6. Responsibilities of parties involved in the notification of a serious breach
7. General considerations for serious breaches
8. Possible actions taken by the EU/EEA Member States concerned (MSC)
Appendix I – Examples of serious breaches
Appendix II – Points to consider for sponsors in relation to the assessment of a breach
Appendix III a – Template form for reporting serious breaches
Appendix III b – Information to be submitted with a notification of a serious breach
Source: Medicines & Healthcare products Regulatory Agency, the UK.
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Nadchodzące badania kliniczne
-
Fondazione Policlinico Universitario Agostino Gemelli...Jeszcze nie rekrutacja
-
National Taiwan University HospitalNational Taiwan University Hospital Bei-Hu BranchRekrutacyjnyPomyślna kaniulacjaTajwan
-
University of British ColumbiaMcMaster UniversityJeszcze nie rekrutacja
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RekrutacyjnyPierwotny aldosteronizm | Antagonista receptora mineralokortykoidowego | FinerenonChiny
-
Zoya Haitov Ben ZikriRekrutacyjnyEkstrakcja zębów mądrości lub implant szczękiIzrael
-
Cairo UniversityRekrutacyjny
-
AstraZenecaMerck Sharp & Dohme LLCRekrutacyjnyPrzerzutowy rak prostaty oporny na kastracjęNiemcy
-
University Hospital, MotolJeszcze nie rekrutacjaCukrzyca typu 1 | Cukrzyca typu 1 z hipoglikemią | Napęd
-
University of LouisvilleJeszcze nie rekrutacjaUraz mięśnia sercowegoStany Zjednoczone
-
University of MiamiRekrutacyjny
-
University of ConnecticutYale UniversityJeszcze nie rekrutacja
-
Pamukkale UniversityJeszcze nie rekrutacjaZespół napięcia przedmiesiączkowego | Śmiech