1. Legal requirement: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
Management of serious breaches of clinical trials authorised in the Europe Union (EU)/ European Economic Area (EEA) is defined by Regulation (EU) No 536/2014, which states in Article 52:
“1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach through the EU portal without undue delay but not later than seven days of becoming aware of that breach.
2. For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.”
© European Medicines Agency, 2021
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
Próximos ensaios clínicos
-
Peking University Third HospitalPeking University; The First Affiliated Hospital of Anhui Medical University; First... e outros colaboradoresRecrutamentoPré-eclâmpsia | Gravidez de alto risco | Gravidez gemelar, condição pré-parto ou complicação | Pré-Período | Placenta Dicoriônica Gêmea Diamniótica | Transfusão de gêmeo para gêmeo como condição pré-parto | Placenta gêmea | Placenta Gêmea Monocoriônica DiamnióticaChina
-
Theodor Bilharz Research InstituteRecrutamento
-
Sormland County Council, SwedenEskilstuna municipalityAinda não está recrutandoDepressão | Sintomas Depressivos
-
Shandong Suncadia Medicine Co., Ltd.Ainda não está recrutandoDoença Renal Diabética Tipo 2
-
University of California, San FranciscoAinda não está recrutandoDoenças Sexualmente Transmissíveis, BacterianasEstados Unidos
-
Ayla ErginRecrutamento
-
Royal Marsden NHS Foundation TrustAinda não está recrutando
-
Zhejiang UniversityNewislet Biotechnology (Shanghai) Ltd.Recrutamento
-
Natera, Inc.Ainda não está recrutandoFalha e Rejeição de Transplante Cardíaco
-
University Hospital, Clermont-FerrandUniversité d'Auvergne; Effik; AUDIPOGAinda não está recrutando
-
M.D. Anderson Cancer CenterAinda não está recrutandoCâncer de esôfagoEstados Unidos
-
Seoul National University HospitalMedtronicRecrutamentoDiabetes tipo 1Republica da Coréia