Nihr Model Non-Commercial Agreement

11. April 2021 Allgemein

For non-commercial trials conducted in England, the HRA statement of activities can be used as an agreement between the sponsor and a participating website and can be found on the HRA website. The model is structured to meet the requirements of non-commercial sponsors and NHS (or other) research organizations, and has been developed as a single UK agreement model, meaning it can be used regardless of where the sponsor and search website are established. 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. If a Noclor partner is a sponsor, it is the funder (and the beneficiary of the main contract with the funder). Noclor will propose to initiate (negotiate all changes as needed) and corresponding contracts /agreements with third parties, as necessary for a pre-study at each start of work. It is the responsibility of the Chief Investigator to ensure that all contracts and agreements are consistent with current practice and are amended, renewed and terminated accordingly. 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 non-commercial research model (MNCA) is a model for documenting the relationship between non-commercial sponsors of a research study and the organization of the health service in which the study and responsibility of non-commercial sponsors takes place. Please note that UoA R-I must be involved in the development of mNCA for all studies. See www.hra.nhs.uk/about-us/news-updates/new-version-uk-wide-model-non-commercial-agreement-mnca-published/ The Industry Collaborative Research Agreement (MICRA) model, launched in February 2011, aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK. 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. All contracts are developed and negotiated by the Noclor Contracts Manager, trained in the application of model agreements and the assessment of deviations from the model. Deviations from models/models and all complex negotiations or intellectual property issues will occur at the Noclor Head of Research and Development.

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