Clinical Trial Conduct for ACT

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

CT Conduct HO

Useful Links

ICH GCP (R2)

ICH E8(R1)

EMA

EU Clinical Trials Regulation

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

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 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

MHRA Guidance on Access to Electronic Health Records

HRA Page on combined approval in the UK

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