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Model site agreements (model contracts, standard research agreements)

 

Contents

Model site agreements

Nationally approved model site 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 site 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.

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, NHS Confederation, Medical Schools Council, UK Clinical Research Collaboration, NHS R&D Forum, and the Institute for Clinical Research. 

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 (HRA) 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.

Commercial model Clinical Trial Agreements (mCTA and CRO-mCTA)

The February 2018 revised model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates are designed to be used without modification for industry-sponsored trials in NHS/HSC patients in hospitals throughout the UK Health Service.

These template model agreements are applicable to the health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 nation specific versions. The accompanying Guidance Notes provide further background, an overview of the changes from the 2011 versions and more information on how and under which circumstances the templates should be used.

Research Sponsors (and CROs) are advised to familiarise themselves with the guidance before making first use of the February 2018 versions. NHS/HSC organisations, and particularly those responsible for negotiating mCTAs on their behalf, are advised to familiarise themselves and their organisational signatories with the revised mCTAs and ensure that they can implement them immediately.

The guidance notes include contact points from where advice and assistance may be obtained.

Implementation of February 2018 versions

The Health Research Authority (HRA) in England and the Health Departments in the Devolved Administrations expect Sponsors (and CROs) to use the February 2018 mCTAs, without modification and in accordance with the guidance, when contracting with NHS/HSC organisations to deliver industry sponsored trials. Similarly, it is expected that NHS/HSC organisations will accept unmodified mCTAs without further review of the standard template elements.

Although the February 2018 mCTAs replace the 2011 versions, it is expected that both Sponsors (CROs) and NHS/HSC organisations exercise pragmatism in managing the transition. For example, we would not expect that any party to a contract negotiation already commenced on the basis of the 2011 version should propose use of the February 2018 version, where this would introduce delay in the contracting process. Even where a sponsor has yet to propose a contract template to a site, we would expect that sites demonstrate pragmatism in continuing to accept unmodified 2011 versions whilst sponsors (and CROs) finalise their internal change management processes to transition to use of the February 2018 version. Further guidance on this transition phase will be given following feedback from stakeholders.

Please visit IRAS (integrated research application system) for further details on how to provide feedback on these new versions.

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 organisations across 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 nocri@nihr.ac.uk

Patient Identification Centre Contracting

NHS and HSC PICs should be set up by through a sub-contracting arrangement with the participating NHS and HSC organisation that the PIC supports. Appropriate data processing arrangements should be put in place by using the appropriate model agreement: