GCP Update Webinar – April 2023


Welcome to the resources page for the GCP Update Course.  Here you will find the recording for the course, handout and useful links.  If you were not able to attend the live session please view the video in the lesson below and then mark the lesson as complete. You will then be able to download your certificate.


Please take a moment to complete the feedback form below:

Course Video

The course Video is in the Lesson below please click here or open the lesson to view the video.  Once you have marked the lesson complete you will be able to download a certificate.


GCP Update Webinar 0423HO

Useful Links


ICH E8(R1)

CTTI CtQ resource

Transcelerate ICH E8 Implementation resources


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.

Quick Guide to the CTR for Sponsors

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 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 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

MHRA response to consultation on new legislation

MHRA Inspection Metrics 2019-2020

FDA Regulations and Guidance

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

BIMO Inspection Report 2021

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