Sponsor Responsibilities for Didact


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 risk assessment 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

Q&A on Reference Safety Information


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