Advanced GCP Course for Vaccitech 2023


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


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Course Video

Course Handout

Advanced GCP 0323 HO

Useful Links



ICH E8(R1)


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

EMA Inspectors Working Group report 2021

EMA Recommendation Paper on Decentralised Elements in Clinical Trials

EMA Guidance on Computerised Systems and Electronic Data in Clinical Trials


MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2017-2018

MHRA Inspection Metrics 2018-2019

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 Guidance on Access to Electronic Health Records

MHRA Guidance on oversight and monitoring of Clinical Trials

MHRA Guidance on Risk Adapted approaches to Clinical Trials

MHRA Guidance on responding to Inspection findings

HRA Page on combined approval in the UK


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

FDA Guidance Financial Disclosure

FDA Guidance Investigator Responsibilities

FDA Guidance IRB Waiver

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