Model Agreements
Nationally approved standard Agreements help speed up the contracting process for industry-sponsored trials carried out in the NHS by removing the need for site-by-site reviews and local legal agreements to be drawn up. This enables trials to start earlier, improving the speed of industry-sponsored clinical trials and giving NHS patients faster access to innovative treatments.
The model Clinical Investigation Agreement (mCIA) for medical technology industry sponsored research carried out in NHS hospitals
The mCIA aims to speed up the contracting process for medical technology industry-funded trials in NHS hospitals.
The Department of Health in partnership with the NHS, the Association of British Healthcare Industries (ABHI) and the UK Health Departments in Scotland, Wales and Northern Ireland launched the mCIA on the 6 November 2008. This important agreement will help medical technology industry-funded research start more quickly, giving NHS patients faster access to innovative treatments.
It has been endorsed for use in unmodified format by the , the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS R&D Forum and the Institute for Clinical Research. A review of experience with its use in the first year will be overseen by the MMTSG.
The Agreement is not appropriate for use in collaborative clinical research, where investigators employed by trusts or universities are involved collaboratively in the design and development of medical devices or the planning and research design aspects of contract commercial investigations. Model agreements for use in collaborative clinical research are being considered for development by the UK Clinical Research Collaboration.
The NHS-ABHI mCIA (England) 2008 (DOC)
Guidance on the use of the mCIA 2008 (PDF)
CRO mCIA
The bipartite mCIA for use by NHS Trusts and the medical technology industry has now been adapted for use in a tripartite format by NHS bodies, sponsors and Contract Research organisations (CRO). The changes made to the mCIA are based on the changes made to the mCTA in developing the CRO mCTA.
The tripartite agreement can now be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation.
The tripartite agreement has been reviewed by representative bodies as before (NHS hospitals, the NHS Confederation, the NHS R&D Forum, the Medical Schools Council, medical technology companies, CROs, the ABHI and the CCRA). All the bodies have either endorsed the CRO mCIA or do not object to its use as a standard agreement template for investigations of medical technology devices.
Versions of the CRO mCIA for use in the Devolved Administrations have also been developed.
CRO mCTA
The bipartite mCTA for use by NHS Trusts and pharmaceutical companies has now been complemented by the publication on 26 October 2007 of the tripartite Contract Research Organisation (CRO) mCTA. Based on the bipartite agreement, this creates a model for contracts to be used whenever the management of a contract commercial clinical trial is outsourced by the sponsor to a Contract Research Organisation. This was negotiated by representatives of the pharma companies, CROs, NHS Trusts, together with DH, ABPI and BIA and like the mCTA it has also been endorsed by the NHS Confederation, the NHS R&D Forum and the Medical Schools Council. Versions have been prepared for use in the Devolved Administrations.
The model Clinical Trial Agreement (mCTA) for pharmaceutical research
mCTA
The mCTA was launched on 30 October 2006 by the Department of Health (DH) in partnership with the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), the NHS, the UK Health Departments and endorsed by the Council of Heads of Medical Schools. The mCTA aims to speed up the contracting process for pharmaceutical industry-funded trials in NHS hospitals.
