Clinical Trials of Investigational Medicinal Products Sponsored by the University

This policy outlines the minimum requirements for CTIMPs sponsored by the University, in order to comply with The Medicines for Human Use (Clinical Trials) Regulations 2004.

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The European Clinical Trials Directive (EUCTD) 2001/20/EC, the GCP Directive 2005/28/EC and The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) and as amended (the Regulations), set out the requirements for implementation of Good Clinical Practice (GCP) in the conduct of Clinical Trials of Investigational Medicinal Products (CTIMPs) within Europe and the UK. As a sponsor the University of Liverpool (hereinafter the University) has specific legal responsibilities in relation to the authorisation and conduct of CTIMPs. The University has  implemented processes to maintain oversight of sponsored CTIMPs to ensure all legal responsibilities are met. CTIMPs can only be undertaken when there are sufficient resources to ensure that all legal requirements are met and can be delivered.

 

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