International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use

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