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

Próximos ensayos clínicos

Clinical Research Jobs

All jobs

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir