Welcome!
Welcome to the course resources page for the Sponsor Responsibilities course. If you were unable to attend the live session you can view the video in the Course Content section at the bottom of this page. Once you have viewed the video your certificate will be available to download.
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Course Handout
Sponsor responsibilities for Didact HO
Useful Links
MHRA GCP forum – lots of useful information and examples
MHRA Inspection Metrics 2017-2018
MHRA Inspection Metrics 2018-2019
MHRA Guidance on responding to Inspection findings
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
HRA Page on combined approval in the UK