A. Legal Requirement, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA
Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [Statutory Instrument 2004/1031], as amended by Statutory Instrument 2006/1928, contains a requirement for the notification of “serious breaches” of GCP or the trial protocol:
“29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of –
(a) the conditions and principles of GCP in connection with that trial; or
(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach.
(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree –
(a) the safety or physical or mental integrity of the subjects of the trial; or
(b) the scientific value of the trial”.
Back to the index of the Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA, Medicines & Healthcare products Regulatory Agency
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 ensayos clínicos
-
University of Novi SadReclutamiento
-
The First Affiliated Hospital of Zhejiang Chinese...ReclutamientoRespuesta inflamatoria | Síndrome de Tourette en niños | Intolerancia a la comidaPorcelana
-
University of Rome G. MarconiUniversity of Bologna; University of the Italian SwitzerlandAún no reclutandoEstrés | Insomnio | Depresión post-partoItalia
-
Selcuk UniversityAún no reclutandoGamificación | Estudiantes de Enfermería | Multiple Intelligence Theory | Disaster NursingPavo
-
NuvoAir Medical PCOptum, Inc.Aún no reclutandoEPOC | Exacerbación de la EPOC | Cardio/Pulm: insuficiencia cardíaca
-
Regeneron PharmaceuticalsIntellia TherapeuticsAún no reclutando
-
Centro di Riferimento Oncologico - AvianoReclutamientoCáncer de pulmón de células no pequeñas metastásico | Mutación del gen ALKItalia
-
Omphis FoundationReclutamiento
-
Institut de cancérologie Strasbourg EuropeContinuum Plus Santé; Plateforme nationale qualité de vie et cancer; WeShareAún no reclutandoImpacto en la Calidad de Vida y Salud de la Solución de Monitoreo Remoto CONTINUUM+ CONNECT (FEGALA)Neoplasias de mama | Neoplasias Pulmonares | Neoplasias prostáticas | Neoplasias colorrectalesFrancia
-
Al-Balqa Applied UniversityLuzmila HospitalAún no reclutando
-
Musculoskeletal Injury Rehabilitation Research...The Geneva Foundation; Uniformed Services University (USU) of the Health Sciences y otros colaboradoresAún no reclutandoTerapia con láser de bajo nivel | Terapia de Fotobiomodulación | Mejora del rendimiento | Fotomedicina | Cuadríceps | Preparación para operaciones especiales
-
The Seventh Affiliated Hospital of Sun Yat-sen...Huizhou Municipal Central Hospital; Dongguan Hospital of Traditional Chinese... y otros colaboradoresReclutamientoFractura de osteoporosis | Fractura de compresión | Osteoporosis Vertebral | Realizar tratamiento PVP/PKPPorcelana