UK Clinical Trials Legislation for Fate


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

HRA Guidance on GDPR

MHRA GCP forum – lots of useful information and examples

MHRA risk assessment 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 Page for GCP

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

HRA Page on combined approval in the UK

MHRA response to consultation on new legislation

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