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

Applying for a Paediatric investigation plan (PIP): review of the EMA guidelines
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 
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

Upcoming Clinical Research Training and Conferences

All events

Prochains essais cliniques

Clinical Research Jobs

All jobs

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner