Abpi Model Agreement

These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; They replace the national versions of 2011. The accompanying guidance notes provide more general information, an overview of changes from the 2011 versions, and other information on how the models should be used and under what circumstances. The MCTA has also been updated for studies conducted with industry-sponsored clinical research organizations (CRO-mCTA), as well as associated guidelines for mCTA and CRO-mCTA. Both agreements have been amended to reflect changes in legislation and guidelines, including the General Data Protection Regulation (EU) 2016/679 and the ABPI Clinical Trial Compensation Guidelines 2015. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support clinical research cooperation involving the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. The new version of the Model Clinical Trials Agreement (MCTA) will allow for the use of a single model contract for commercial research and development in England, Scotland, Wales and Northern Ireland, resulting in the removal of unnecessary management for conducting the same study across the UK. Before research work can begin, sponsors and host institutions must have appropriate agreements. It may take a lot of time and effort to design different versions of these agreements for different research scenarios. To simplify this process, UKCRC partners and stakeholders have developed a series of model conventions that can be used without modification „from the bar“. „Scotland has been at the centre of negotiations for the development of the new Clinical Trial Agreement (MCTA) model. The establishment of a single agreement in the UK streamlines the research environment across the UK and improves our international competitiveness.

Revised in February 2018, the Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) models are designed to be used without modification for industry-sponsored studies of NHS/HSC patients in hospitals across the UK Health Service. The model clinical trials agreement for primary supply research sponsored by the pharmaceutical and biopharmaceutical industry (Primary Care mCTA) has been welcomed by two new draft contracts that will facilitate research and development of life-changing vaccines in different parts of the UK. 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, academia, the NHS and the Intellectual Property Office have worked with legal advice to develop a model agreement that can support all collaborative research scenarios. The organizations participating in the working group agreed on a statement of approval to encourage the use of these agreements to streamline the contractual process for tied research. The model conventions are available on the IRAS website here. The tripartite agreement is intended to be used when the management of a commercial clinical trial is subcontracted by the sponsor to a contract research organisation. . . .

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