2011 versions of the mCTA, CRO mCTA, mCIA and CRO mCIA
The 2011 versions of these agreements, published in December 2011 include two changes from the original versions: 

• Definitions - In the past, some Universities that are the substantive employers of staff involved in clinical trials and clinical investigations at NHS Trusts were concerned that they might not be covered by the terms of the ABPI or ABHI Form of Indemnity. These Universities often requested the industry sponsors of clinical trials and clinical investigations to issue them with their own Form of Indemnity, separate from that included in the mCTA or mCIA between the NHS body and the sponsor. The new definition of Agent makes it clear that in the context of clinical trials and clinical investigations, Universities are agents of the NHS body that enters into the clinical trial or clinical investigation agreement with the sponsor.

• Clause 3.5 - The anti-bribery and anti-corruption provisions of earlier versions of the mCTAs and mCIAs, have been revised to take account of the introduction of the Bribery Act 2010, permitting sponsors to comply with their obligations under US as well as UK legislation. In the earlier versions, Clause 3.5 referred only to corrupt actions that might be committed by Sponsors. The Bribery Act 2010 and similar US legislation makes it necessary for Sponsors to include in agreements with contractors provisions to discourage any corrupt acts on contractors’ parts. The modified Clause 3.5 states that either party to a bipartite agreement (sponsor or NHS body), or any party in the case of CRO-managed trials and investigations, can terminate the agreement in the event that the other party (or any other party in the case of the CRO-managed studies) commits any offence covered by the Bribery Act 2010, in relation to the agreement or the clinical study.

These changes have been agreed in discussions between the UK Health Departments, the National Institute for Health Research and industry bodies. Versions have been prepared for use in the Devolved Administrations. These are available on the UKCRC website.

model Clinical Trial Agreement (mCTA) for pharmaceutical research

The mCTA aims to speed up the contracting process for pharmaceutical industry-funded trials in NHS hospitals.

The mCTA is endorsed by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), the NHS, UK Health Departments, National Institute for Health Research, and the Medical Schools Council.

Contract Research Organisation model Clinical Trial Agreement (CRO mCTA) for pharmaceutical research

The tripartite Contract Research Organisation (CRO) mCTA 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.

The CRO mCTA is endorsed by pharmaceutical companies, CROs, NHS Trusts, the UK Health Departments, National Institute for Health Research, ABPI, BIA, NHS Confederation, NHS R&D Forum and the Medical Schools Council.

model Clinical Investigation Agreement (mCIA) for medical technology industry

The mCIA aims to speed up the contracting process for medical technology industry-funded trials in NHS hospitals.

It is endorsed for use in unmodified format by the Ministerial Medical Technology Strategy Group (MMTSG), UK Health Departments, National Institute for Health Research, Association of British Healthcare Industries (ABHI), NHS Confederation, Medical Schools Council, UK Clinical Research Collaboration, NHS R&D Forum, and the Institute for Clinical Research.  

Contract Research Organisations model Clinical Investigation Agreement (CRO mCIA) for medical technology industry

The tripartite agreement is for use when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation.

The CRO mCIA 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, UK Clinical Research Collaboration, NHS R&D Forum, and the Institute for Clinical Research.