MTIIs were developed by the UK government in collaboration with the Association of the British Pharmaceutical Industry (ABPI), in collaboration with stakeholders such as the Health Research Authority and the Medical Research Council. In addition, there are separate model agreements for non-commercial research/investigation, collaborative research and primary procurement studies. Changes to the 2018 versions are not essential and are intended to reflect current guidelines and legislation. The guidelines that accompany MCCs provide additional information, an overview of the changes and information on how and when models should be used. The key changes to the models for 2018 are the most important: to address these challenges, the CCTCC mCTA Central Working Group reviewed the MCTA text with the help of Innovative Medicines Canada and its affiliates, HealthCareCan and numerous provincial clinical study groups. Given that many innovative pharmaceutical companies (including members of Innovative Medicines Canada) are participating in an International TransCelerate (CLEAR ) common language evaluation and reconciliation initiative to address five controversial clauses in clinical study contracts, clear clauses have also been set for review. Click here to learn more about these latest developments. “The work done with the commercial sector to revise this model agreement will be invaluable for Northern Ireland – health and social care trusts and commercial sponsors can quickly sign contracts for studies that allow patients to access innovative new research treatments sooner.” An update of the Model Clinical Trial Agreement (MCTA) has been published for industry-sponsored clinical studies of patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the United Kingdom. The HRA has welcomed two new contract projects that will facilitate vaccine research and development in different parts of the UK. “Scotland has been at the centre of negotiations on the development of the new model of the Clinical Trials Agreement (MCTA). Implementing a single UK agreement streamlines the research environment across the UK and improves our international competitiveness. The Model Clinical Trials Agreement (mCTA) of February 2018 and the Clinical Research Organisation Model Clinical Trials Agreement (CRO-mCTA) replace country-by-country versions and are an important step in streamlining commercially sponsored students throughout the UK health system, eliminating unnecessary administrations. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations.

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