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Model clinical trials agreements

  • Last modified date:
    15 March 2011

Nationally approved standard agreements help speed up the contracting process for clinical trials carried out in the NHS. The agreements are part of a system of reforms to streamline the process of conducting clinical trials in the NHS, as part of the NIHR goal of creating a world class clinical research environment.

A series of model agreements has been drawn up by the UK Health Departments, the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), and the Association for British Healthcare Industries (ABHI), as appropriate, and endorsed for use in unmodified format by representatives of the NHS and universities.

model Industry Collaborative Research Agreement (mICRA)

The model Industry Collaborative Research Agreement launched on 23 February 2011 is designed to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK.

The model Agreement is supported by a comprehensive Guidance, which sets out the aims and provides details on how the Agreement should be used in the development of contracts for specific clinical research collaborations. A Decision Tree is also available to guide users in identifying when studies are collaborative and whether mICRA is applicable. The Agreement has a choice of options for clauses covering Intellectual Property arrangements and the Decision Tree guides users through this process.

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 the model Agreement that can be used to 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.

Contract Research Organisations model Clinical Investigation Agreement (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.

Model Clinical Investigation Agreement for medical technology industry sponsored research in NHS hospitals

The mCIA launched in 2008 is designed to simplify and speed up the process for signing off and initiating trials involving NHS patients in NHS hospitals. It removes any need for either sponsors or hospitals to undertake further legal review of contracts in response to another party proposing modifications. It is intended that the mCIA be used routinely without modification by all medical technology industry sponsors of contract clinical research in NHS hospitals in which NHS patients are recruited. Versions have been prepared that reflect the special governance and legal arrangements of Scotland, Northern Ireland and Wales.

The documents are endorsed for use without modification by the four UK Health Departments and by the Association of British Healthcare Industries, the NHS Confederation, the NHS Forum, the Medical Schools’ Council, the UK Clinical Research Collaboration, the Institute for Clinical Research, and by the Ministerial Medical Technology Strategy Group.

Discussions on the scope and format of the mCIA were initiated with representatives of the ABHI and the Medicines and Healthcare products Regulatory Agency. In depth discussions were also held with representatives of NHS Trusts, the four UK Health Departments, and NHS Innovation Hubs.

The Agreement has been designed to provide for transparency, probity, and the protection of all relevant interests with terms that are legally robust.

Use of the mCIA is not mandatory, but it is expected that neither NHS bodies that want to carry out trials nor sponsors keen to complete device studies would risk the delays that would result from the introduction of changes.

Contract Research Organisations model Clinical Trial Agreement (CRO mCTA)

Sponsors often outsource trials to CROs to simplify their management and therefore most of the trust’s dealings are likely to be with the CRO, but there are a number of issues over which sponsors need to maintain direct involvement. These include:

  • ABPI indemnity
  • intellectual property
  • publication
  • Freedom of Information Act enquiries

The CRO mCTA contains fundamentally the same provisions as the 2006 mCTA. However, in respect of a number of points, in devising the trial-specific agreement the parties have to consider whether it is the sponsor or the CRO (or both) with which the NHS Trust interacts. These options are set out in the model agreement. 

model Clinical Trials Agreement (mCTA) for pharmaceutical research

The mCTA is a model agreement intended for use, by all pharmaceutical and biotech companies sponsoring trials and the NHS hospitals carrying them out, without any modification (i.e., without modification except for the addition of details of the contracting parties, the trial protocol and specific financial arrangements).

The mCTA covers all the issues that sponsor companies and NHS bodies believe are essential to represent the legal relationship between them.

The documents are endorsed for use without modification by Health Departments throughout the UK, the trade bodies (ABPI and BIA), the NHS Confederation, the NHS R& D Forum, the UK Clinical Research Collaboration, the Foundation Trust regulator (Monitor), and the Council of Heads of Medical Schools.

Versions have been also prepared that reflect the special governance and legal arrangements of Scotland, Northern Ireland and Wales.

The mCTA is designed to simplify and therefore speed up the process for signing off and initiating trials involving NHS patients in NHS hospitals. It removes any need for either sponsors or hospitals to undertake further legal review of contracts in response to another party proposing modifications.

Like the ABPI Form of Indemnity, use of the Agreement is not mandatory, but it is expected that neither NHS bodies that want to carry out trials nor sponsors keen to complete drug development programmes would risk the delays that would result from the introduction of changes.

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