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):

A. Legal requirement

B. Purpose of the requirement

C Purpose of this guidance

D. Arrangements for notification

E. Identifying serious breaches

F. MHRA Actions

G. Organisation Responsibilities

H. References

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

ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
The study of the new investigational drug for acute myeloid leukemia and myelodysplastic syndrome
Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers
Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults
A new study of Dexpramipexole in adolescents and adults with severe Eosinophilic Asthma
The study of the DO-2 drug in patients with advanced or refractory solid tumours
Study to compare AT278 with standard insulin aspart NovoRapid® in participants with Type 2 Diabetes

Prochains essais cliniques

Clinical Research Jobs

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue