GCP Update Webinar – Broadcast 22 November 2021

Welcome to the resources page for the GCP Update Webinar June 2021. If you were unable to attend the live event you can view the recording in the course materials at the bottom of this page. Once you have viewed it and marked the lesson as completed your certificate will be available to download.

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Handout

GCP Update 1121 HO

Useful Links

EU Clinical Trials Regulation

Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU

ICH GCP (R2)

MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

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

Q&A on Reference Safety Information

EMA training on the Clinical Trials Regulation

FDA 21 CFR part 11

FDA 21 CFR part 50

FDA 21 CFR part 54

FDA 21 CFR part 56

FDA 21 CFR part 312

FDA Clinical Trial Guidance Documents