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Model Agreement For Non-Commercial Research In The Nhs

Model Agreement For Non-Commercial Research In The Nhs

The revised models for February 2018 of the Clinical Trial Agreement (mCTA) and the Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) are designed to be used without modification for industry-sponsored studies of patients with NHS/HSC in hospitals across the UK health service. 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. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations. Appropriate data processing agreements should be concluded using the appropriate agreement model: www.nhsresearchscotland.org.uk/services/permissions-co-ordinating-centre/permissions the submission is structured to meet the requirements of non-commercial proponents and NHS research organizations (or other) research entities and that it has been developed as a single UK agreement model, meaning that it can be used regardless of where the proponent and research site are established. Primary Care mCTA was designed to simplify and expedite the process of stopping and initiating pharmaceutical and biopharmaceutical clinical trials on primary care patients. The intention is that the mCTA Primary Care Centre will be used regularly without modification by all promoters of the pharmaceutical and biopharmaceutical industry of contract clinical research, where patients with NHS are recruited into primary care. In such cases, no further legal review is required, saving money and time. 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 with legal opinions to develop a model agreement that could support all collaborative research scenarios. Organizations participating in the working group agreed on a statement of support in which they encouraged their use to streamline the collaborative research allocation process.

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.


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