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 suite of model Agreements are supported by Guidance which sets out the aims and provides details on how the Agreement should be used in the development of contracts for clinical research sponsored by pharmaceutical, biopharmaceutical or medical technology companies.
2014 versions of the mCIA, CRO mCIA
The 2014 versions of these agreements, published in April 2014:
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 triapartite 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.
2011 versions of the mCTA, CRO mCTA
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, NIHR, 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.
Primary Care model Clinical Trial Agreement (Primary Care mCTA)
The model Clinical Trial Agreement for biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and agreed by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly research-active general Practitioners, the British Medical Association, the Medical Protection Society, and the UK health departments. The Health Research Authority supports the use of model agreements.
The Primary Care mCTA is designed to simplify and therefore speed up the process for signing off and initiating pharmaceutical and biopharmaceutical clinical trials involving patients in primary care. It is intended that the Primary Care mCTA is used routinely without modification by all pharmaceutical and biopharmaceutical industry sponsors of contract clinical research in which NHS patients are recruited in primary care. In such cases, no further legal review is necessary, saving money and time.
model Industry Collaborative Research Agreement (mICRA)
The model Industry Collaborative Research Agreement (mICRA) launched in February 2011 aims to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisationsacross the UK.
A Decision Tree is available to guide users in identifying when studies are collaborative and whether mICRA is applicable.
The mICRA was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, universities, the NHS, and the Intellectual Property Office, worked together with expert legal opinion to develop a model Agreement that can support all collaborative research scenarios. Organisations involved in the working group have agreed a Statement of Endorsement encouraging its use, to streamline the contracting process for collaborative research.
Feedback on the use of the mICRA is welcomed to help inform its future development. Email comments to: email@example.com
The Health Research Authority is seeking comment on a revised model Non-Commercial Agreement (mNCA) from 12 January to 3 February 2015.
The original mNCA was released in 2008. It was intended to be used to agree the relationship between, and the responsibilities of, non-commercial sponsors and their research sites in relation to specific studies. The body of the agreement was written for use without modification, whereas the schedules could be tailored to reflect study specifics. Use of the template thereby ensured compliance with applicable UK law and institutional arrangements whilst minimising the review required at site.
Although the mNCA has achieved wide acceptance from NHS sites, a large number of non-commercial sponsors have retained their own templates whilst others have adopted the mNCA with modifications, requiring sites to undertake additional review. Against this background, and aware that the research landscape has moved on since 2008, we have worked with a broad range of partners to revise and update the mNCA.
Comment is invited from all interested parties, particularly those responsible either for issuing agreements on behalf of non-commercial sponsors or signing agreements for NHS research sites.
Any comments should be sent to hra.mNCA@nhs.net no later than 5pm on Tuesday 3 February 2014.
Feedback received will then be analysed before a final re-drafting of the template for release.