Guidance for the notification of serious breaches of GCP or the trial protocol

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. Potential actions by the MHRA

G. References

Appendix I: Notification Examples

Appendix II: Notification Form

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Guidance for the notification of serious breaches of GCP or the trial protocol

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