Sponsorship

This section contains the following: 

• Introduction 
• Things to consider
• Additional resources

Introduction 

A sponsor is defined in the EU Clinical Trials Directive 2001/20/EC  as an individual, company, institution or organisation which takes responsibility for the initiation and management and /or financing of a clinical trial.  The sponsor is responsible for good clinical practice (GCP) within a trial.  The sponsor can be a group but it is important if this is the case that  roles and responsibilities are allocated and agreed  between the organisations in writing.  


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Things to consider 

• The trial cannot commence until sponsorship arrangements are agreed and in place.
• The sponsor should define, establish and allocate all trial related duties and functions. 
• UK regulations enable allocation/delegation of sponsorship responsibilities.

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Additional resources 

Clinical Trials Tool Kit

On this site you will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.  These regulations implement the EU Clinical Trials Directive in the UK. Even if your research falls outside the Regulations, you could still find the Route Maps useful.  Much of the advice they contain is relevant to clinical trials and research more generally.

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This page was last updated September 2008.