Welcome!
Welcome to the resources page for the UK Clinical Trials Legislation Course. Here you will find the recording for the course, handouts and useful links.
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Course Video
Course Handout
UK Clinical Trials legislation for Fate HO
Useful Link
MHRA GCP forum – lots of useful information and examples
MHRA Inspection Metrics 2017-2018
MHRA Inspection Metrics 2018-2019
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
MHRA Guidance on Access to Electronic Health Records
MHRA Guidance on oversight and monitoring of Clinical Trials
MHRA Guidance on Risk Adapted approaches to Clinical Trials
MHRA Guidance on responding to Inspection findings