Clinical Research Organisation model Clinical Trial Agreement

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

  • The pharmaceutical company sponsoring a trial
  • The contract research organisation (CRO) managing the trial
  • The NHS organisation where the trial takes place.

The CRO mCTA is based on the bipartite model Clinical Trial Agreement, used by pharmaceutical companies and NHS organisations. It is tailored to be used without modification for CRO-managed trials in patients in hospitals throughout the UK Health Service.

2011 versions of the CRO mCTA 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.