The GCP Inspectorate has updated the Serious Breaches Guidance.

 

Guidance for the Notification of Serious Breaches of GCP or the Trial ProtocolPDF file (opens in new window)

 

Notification of Serious Breaches of GCP or Trial Protocol form Word file (opens in new window)

 

Email address for reporting serious breaches: GCP.SeriousBreaches@mhra.gsi.gov.uk