Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol, Version 6, 08 Jul 2020, MHRA
Table of Contents
Page Number(s):
D. Arrangements for notification
E. Identifying serious breaches
G. Organisation Responsibilities
Appendix I - Expectations for Specific Serious Breach Topics
Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)
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
Kommande kliniska prövningar
-
National Institute of Medical Sciences and Nutrition...Har inte rekryterat ännuRhA - Reumatoid artrit
-
Institute of Liver and Biliary Sciences, IndiaHar inte rekryterat ännuAkut-på-kronisk leversviktIndien
-
Centre Leon BerardHar inte rekryterat ännuMagcancer | Oesogastric Junction CancerFrankrike
-
TC Erciyes UniversityRekryteringEndodontisk sjukdomKalkon
-
Casa di Cura Privata 'Malzoni - Villa dei Platani...Rekrytering
-
Assembly BiosciencesHar inte rekryterat ännuÅterkommande genital herpes simplex typ 2Nya Zeeland
-
Cerenovus, Part of DePuy Synthes Products, Inc.Har inte rekryterat ännuAkut ischemisk strokeFörenta staterna
-
Pamukkale UniversityHar inte rekryterat ännuUrinblåsa, överaktivKalkon
-
China-Japan Friendship HospitalHar inte rekryterat ännuFetma | Diabetes | Gallstenar | Biliär Stasis
-
AstraZenecaDaiichi SankyoHar inte rekryterat ännuMetastaserad bröstcancer | HER2-positiv bröstcancer | Obegreppbar bröstcancer | HER2-lågt uttryckande bröstcancerKanada
-
Chinese University of Hong KongRekrytering
-
Central Hospital, Nancy, FranceHar inte rekryterat ännu