GCP Update for Boyds

Welcome!

Welcome to the resources page for the GCP Course.  Here you will find the course handouts and useful links.

Take the course online:

If you were not able to attend the live session please click here to view the video or in the lesson below and then mark the lesson as complete. You will then be able to download your certificate.

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Handout

GCP Update Webinar Boyds 1123HO

Useful Links

International

Nuremberg Code

Declaration of Helsinki

ICH GCP (R2)

ICH E8(R1)

UK

MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2019-2020

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 response to consultation on new legislation

Research Reset

O’Shaughnessy report

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

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