Welcome!
Welcome to the course resources page for the GCP Update course. If you need a certificate for this course please view the video and then open the lesson at the bottom of this page to confirm your completion of the course. You will then be able to download your certificate.
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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
MHRA Inspection Metrics 2018-2019
MHRA Guidance on Access to Electronic Health Records
HRA Page on combined approval in the UK
Q&A on Reference Safety Information
FDA Clinical Trial Guidance Documents
Transcelerate Risk Based Monitoring Page – lots of information and tools
COVID-19
MHRA Guidance: https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/
AND: https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19
EMA Guidance: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
AND:
FDA Guidance: https://www.fda.gov/media/136238/download