MHRA produced FAQs for Regulatory Documents (inc protocol, CSRs & publications)
[SIZE=4][B]1. What is the definition of minor and major protocol violation according to GCP or other legislation reference? [/B][/SIZE]
There is no definition, within both GCP and the UK legislation, of the terms major or minor protocol violation and therefore the terms do not have a specific reference in law. There are a number of generalised definitions that are currently in use within the industry which you will undoubtedly find by an internet search, but as these are neither referenced in the UK legislation nor in GCP we cannot comment on their usage.