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
Upcoming Clinical Trials
-
King Chulalongkorn Memorial HospitalHealth Systems Research Institute,ThailandRecruitingDementia | Alzheimer Disease | Cognitive DeclineThailand
-
Hospital Universitari de BellvitgeHospital Universitario Ramon y Cajal; Complejo Hospitalario de Navarra; University... and other collaboratorsNot yet recruitingBiliary Tract Neoplasms | Pancreatic Cancer Resectable | Malignant Biliary ObstructionSpain
-
University Hospitals of North Midlands NHS TrustNot yet recruiting
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingDiffuse Cutaneous Systemic SclerosisChina
-
AstraZenecaRecruiting
-
VA Eastern Colorado Health Care SystemRecruitingDepression | SuicideUnited States
-
Convalife (Shanghai) Co., Ltd.Not yet recruitingHer2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
-
Stanford UniversityNot yet recruiting
-
Sunway UniversityRecruitingAging | Elderly | Cognitive Decline | Intervention Study | Physical DeclineMalaysia
-
The First Affiliated Hospital with Nanjing Medical...Zhejiang Cancer HospitalRecruiting
-
University GhentNot yet recruitingHelp-Seeking Behavior | Suicide Prevention | MenBelgium
-
Beijing Chest Hospital, Capital Medical UniversityNot yet recruitingLimited-stage Small-cell Lung Cancer