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.

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