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Course Handout
Useful Links
Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU
MHRA GCP forum – lots of useful information and examples
MHRA Inspection Metrics 2017-2018
MHRA Inspection Metrics 2018-2019
MHRA Guidance on responding to Inspection findings
MHRA Infringement Notice: Freelance monitor
MHRA Infringement notice: Investigator
MHRA Serious Breaches Guidance
UK SI 2004 1031 – Medicines for Human Use (Clinical Trials) Regulations
UK SI 2006 1928 – Medicines for Human Use (Clinical Trials) Amendment Regulations