Clinical Research Organisation model Clinical Investigation Agreement
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 is for use when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. This agreement is endorsed for use by the UK Health departments, National Institute for Health Research, Association of British Healthcare Industries (ABHI), NHS Confederation, Medical Schools Council, NHS R&D Forum, Institute for Clinical Research and the UKCRC.
2014 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.