model Clinical Investigation Agreement
(mCIA)
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.
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.
Available links: