Abpi Model Agreement

The Triapartit agreement is intended in the event that the sponsor`s management of a commercial clinical trial is outsourced to a contract research organization. CRO mCIA is supported by the UK Health Services, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS Research Forum and the Institute for Clinical Research. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations. Data processing agreements should be concluded using the corresponding model agreement: “In Wales, we have developed a model agreement with our business and government colleagues in the UK that will make a vital contribution to improving the speed, ease and effectiveness of high-quality research for the benefit of patients. The collaborative approach recommends the systematic and unchanged application of the clinical trial agreement model, and we support its application. “Work 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. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions. The accompanying guidelines provide more general information, an overview of changes from the 2011 versions, and additional information on how models should be used and under what circumstances. National site location agreements help speed up the process of awarding trials in the NHS supported by industry, as there is no longer a need for site-by-site controls and local legal agreements. This allows studies to start earlier, improve the speed of industry-sponsored clinical trials and enable patients with NHS to access innovative treatments more quickly. The range of model location agreements is supported by guidelines that specify the objectives and modalities of the use of the agreement in the development of clinical research contracts supported by pharmaceutical, biopharmaceutical or medical companies. The new version of the Model Clinical Trials Agreement (mCTA) will allow the use of a single model contract for commercial research and development in England, Scotland, Wales and Northern Ireland, resulting in the breakdown of unnecessary administrations to conduct the same study in the UK.

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. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK. Before research can begin, sponsors and host institutions must have appropriate agreements. Considerable time and effort may be required to develop different versions of these agreements for different research scenarios.

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