Welcome!
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.
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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.
Handout
Useful Links
Transcelerate ICH E8 Implementation resources
EMA
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
UK
MHRA GCP forum – lots of useful information and 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 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 Clinical Trial Guidance Documents
FDA Guidance Financial Disclosure