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
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
10 – 11 April 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 18 April 2024InformaUnited States
-
17 – 19 April 2024SCDM (Society of Clinical Data Management)Poland
-
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
Kommende kliniske forsøg
-
Ruijin HospitalRekrutteringAntifosfolipidsyndrom (APS)Kina
-
Cybrexa TherapeuticsIkke rekrutterer endnuPlatin-resistent kræft i æggestokkene | Ildfast ovariekarcinom
-
Universidad Complutense de MadridOsteology FoundationRekrutteringDental malocclusion | Maxillær mangelSpanien
-
Rhode Island HospitalBrown UniversityIkke rekrutterer endnu
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Institutes of Health (NIH)Ikke rekrutterer endnu
-
Beijing Tiantan HospitalIkke rekrutterer endnuIskæmisk slagtilfælde | Kognitiv svækkelse efter slagtilfælde
-
McGill University Health Centre/Research Institute...Ikke rekrutterer endnuSunde emner | Type 1-diabetes (T1D)
-
jingxueRekrutteringPancreascarcinom; lipoprotein a; Samlet overlevelse; PrognoseKina
-
Jiangsu Province Nanjing Brain HospitalRekruttering
-
Mount Sinai Hospital, CanadaIkke rekrutterer endnuHypotension ved induktionCanada
-
UCB Biopharma SRLIkke rekrutterer endnuFravær i barndommen Epilepsi | Juvenile Absence Epilepsi
-
North Jersey AIDS Alliance dba North Jersey Community...City University of New York, School of Public HealthIkke rekrutterer endnuHIV-infektioner | Overdosis | HCV
Clinical Research Jobs
Abonner