GCP Introduction/Refresher for Vaccitech

Welcome!

Welcome to the course resources for the GCP Introduction/Refresher Course.  In the lesson linked at the bottom of this page you can find the course video.  If you were unable to attend on the day and need a certificate you will be able to download your certificate once you have viewed the video and marked the lesson as complete .

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Course Handout

GCP intro 2021 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)

UK SI 2004 1031 – Medicines for Human Use (Clinical Trials) Regulations

UK SI 2006 1928 – Medicines for Human Use (Clinical Trials) Amendment Regulations

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

FDA Guidance 1572