Welcome!
Welcome to the course resources page for the Clinical Trial Conduct course.
Certificate
If you need a certificate for this course please view the video and then open the lesson at the bottom of this page, watch the video and mark the lesson as completed. You will then be able to download your certificate.
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Handout
Useful Links
EMA
Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU
EMA page on the Clinical Trials Information System
Q&A on Reference Safety Information
EMA training on the Clinical Trials Regulation You can view and download the presentations but can’t view the recordings.
EMA guidance on Serious Breaches
UK
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