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Welcome to the resources page for the GCP Introduction/Refresher Course. Here you will find the recording for the course, handouts and useful links.
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Course Video
Course Handout
Useful Links
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
UK
MHRA GCP forum – lots of useful information and 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 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 Regulations and Guidance
FDA Clinical Trial Guidance Documents
FDA Guidance Financial Disclosure
FDA Guidance Investigator Responsibilities