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Model Agreements

Sponsors of research and host institutions need to have appropriate agreements in place before a piece of research can start. With many different organisations taking on the role of sponsor, more resources have been used in drafting different versions of agreements for the various research scenarios. The UKCRC Partners and stakeholders are developing a suite of model agreements, which can be used "off the shelf". Four agreements have been published or are in development. These are the:

  • Revised model Clinical Trial Agreement (mCTA). This is designed to be used without modification for pharmaceutical industry-sponsored contract research trials in patients in NHS hospitals throughout the UK. It was launched in October 2006.
  • Contract Research Organisation model Clinical Trial Agreement (CRO mCTA). This is a tripartite agreement between a pharmaceutical company sponsoring a trial, the contract research organisation (CRO) managing it and the NHS organisation where the trial takes place. It was launched in October 2007. 
  • Model Clinical Investigation Agreement (mCIA). This is designed for use in industry-sponsored medical device clinical investigations, and is still in development.
  • Model agreement for non-commercial research in the Health Service. This agreement has been developed under the UKCRC umbrella through a consultative process. It is at an advanced stage of development. 

 

A PowerPoint slide giving an overview of the suite of model agreements is available to download.