Model Clinical Investigation Agreement

The model Clinical Investigation Agreement (mCIA) is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service.

2014 versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.

The UKCRC recognises that ensuring efficient regulatory processes is a fundamental part of building a first class clinical research environment. The development of the model Clinical Investigation Agreement is another important step in this process, reflecting the breadth of issues that the UKCRC partners tackle together. The UKCRC Partners strongly advocate its use without modification.