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On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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
Tulevat kliiniset tutkimukset
-
University Hospital, ToulouseEi vielä rekrytointia
-
Center for Sight Las VegasEi vielä rekrytointiaPrimaarinen avoimen kulman glaukoomaYhdysvallat
-
Shanghai Mental Health CenterEi vielä rekrytointiaMasennushäiriö | Masennushäiriöt | Masennushäiriö
-
University of LiegeCentre Hospitalier Universitaire de LiegeRekrytointiKriittinen sairaus | ICU | Lähellä kuolemaa kokemus | TietoisuusBelgia
-
Cancer Institute and Hospital, Chinese Academy...Ei vielä rekrytointia
-
Charite University, Berlin, GermanyLudwig-Maximilians - University of Munich; Bogomolets National Medical UniversityRekrytointi
-
The Cleveland ClinicMedtronic; Raynor Cerebellum ProjectRekrytointiOlennainen vapina | VapinaYhdysvallat
-
William BlackNational Institute of Arthritis and Musculoskeletal and Skin Diseases...Ei vielä rekrytointia
-
University of SheffieldRekrytointiGeneettiset neurokehityshäiriötYhdistynyt kuningaskunta
-
Engeneic Pty LimitedHerbert Irving Comprehensive Cancer CenterEi vielä rekrytointiaPDAC - Haiman kanavan adenokarsinooma | Haimasyöpä, metastaattinenYhdysvallat
-
Nanjing Legend Biotech Co.Ei vielä rekrytointiaUusiutuneet/tulenkestävät autoimmuunisairaudetKiina
-
Zhejiang UniversityRekrytointiAivoverisuonitauti | Aikuinen aivokasvainKiina
