MHRA Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol
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Table of contents
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A. Legal requirement
1
B. Purpose of the requirement
1
C. Purpose of this guidance
2
D. Arrangements for notification
2
E. Identifying serious breaches
3
F. MHRA Actions
5
G. Organisation Responsibilities
5
H. References
6
Appendix I - Expectation for Specific Serious Breach Topics
7
Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)
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