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On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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
Aankomende klinische onderzoeken
-
National Cancer Institute (NCI)WervingGeavanceerd niet-kleincellig longcarcinoom | Terugkerend niet-kleincellig longcarcinoom | Stadium IIIB Long niet-kleincellige kanker AJCC v7 | Stadium IV Long Niet-kleincellige kanker AJCC v7Verenigde Staten
-
National Cancer Institute (NCI)NRG OncologyWervingGemetastaseerd colorectaal adenocarcinoom | Stadium IV Colorectale kanker AJCC v7Verenigde Staten
-
National Institute of Mental Health (NIMH)WervingUnipolaire depressieVerenigde Staten
-
National Cancer Institute (NCI)WervingStadium IIA longkanker AJCC v8 | Stadium IIB longkanker AJCC v8 | Stadium IIIA Longkanker AJCC v8 | Stadium IIIB Longkanker AJCC v8 | Stadium IB Long Niet-kleincellig carcinoom AJCC v7 | Stadium II Long Niet-kleincellige kanker AJCC v7 | Stadium IIIA Long niet-kleincellige kanker AJCC v7Verenigde Staten, Guam, Puerto Rico
-
National Cancer Institute (NCI)WervingStadium III huidmelanoom AJCC v7 | Stadium IV huidmelanoom AJCC v6 en v7Verenigde Staten
-
Vanderbilt University Medical CenterCurePSPNog niet aan het wervenProgressieve supranucleaire verlamming
-
William Beaumont HospitalsNog niet aan het werven
-
Mario Negri Institute for Pharmacological ResearchNog niet aan het wervenAutosomaal dominante polycysteuze nierziekte (ADPKD)Italië
-
Peking UniversityWervingDepressie - Ernstige depressieve stoornisChina
-
Fondazione Policlinico Universitario Agostino Gemelli...Nog niet aan het wervenZiekte van AlzheimerItalië
-
Gérond'ifNog niet aan het wervenOudere patiënten | Medische zorg | Sociale zorgFrankrijk
-
Indapta Therapeutics, INC.Nog niet aan het wervenZiekten van het zenuwstelsel | Ziekten van het immuunsysteem | Multiple sclerose | Auto-immuunziekten van het zenuwstelsel | Demyeliniserende ziekten | Auto-immuunziekten | Secundaire progressieve multiple sclerose (SPMS) | Primaire progressieve multiple sclerose (PPMS) | Niet-actieve secundaire progressieve... en andere voorwaardenVerenigde Staten