The MHRA has updated it's guideline on Serious Breaches.  This requirements has implications for countries outside the UK if UK sites are involved in the study.  You can find the new guideline and also a standard form here: http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/index.htm  The documents need to be downloaded from the link towards the bottom right of the page.

The guidance introduces a standard form, expands on sponsor, CRO and investigator responsibilities and also outlines the action the MHRA will take when you report a serious breach.  They have also expanded their list of examples in the appendix.