Clinical Research Organisation model Clinical Investigation Agreement (CRO mCIA)

June 2009

The Contract Research Organisation model Clinical Investigation Agreement (CRO mCIA) is a tripartite agreement between:

  • The company sponsoring commercial research involving medical device(s)
  • The contract research organisation (CRO) managing the research
  • The NHS organisation where the research takes place.

The CRO mCIA is based on the bipartite model Clinical Investigation Agreement (mCIA), which is for use by NHS Trusts and the medical technology industry. This tripartite agreement can be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. It is tailored to be used without modification for CRO-managed clinical investigations of medical devices in patients in hospitals throughout the UK Health Service.

Four versions of the CRO mCIA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.

©2005 United Kingdom Clinical Research Collaboration.