Hra Model Non Commercial Agreement

For all non-commercial studies requiring a UK local information package, a schedule or SoECAT is required. This will identify appropriate resources to support the conduct of studies and clarify for NHS/HSC participating organisations how the costs of participating in a study are allocated. See If you are applying for HRA clearance for your study, it may also be useful to refer to the document containing the HRA`s evaluation criteria and standards, as it contains a reflection on the use of model contracts. You can find the document on our HRA Special Authorization page. “The revised MNCA should be used instead of the previous version 1.0, as it contains important clauses to bring it into compliance with the GDPR, and we will soon publish further guidelines for the implementation of existing agreements with the regulation. The model is structured in such a way that it meets the requirements of non-commercial sponsors and NHS (or other) organisations carrying out the research and has been designed as a single UK-wide contract template, meaning that it can be used regardless of where the promoter and research site are established. For non-commercial studies, the Health Research Authority (HRA) is testing the use of templates for event programmes and activities to collect all information related to study activities at local level. For more information, visit the HRA website. The Model Non-Commercial Agreement (MNCA) for research is a model for documenting the relationship between and responsibilities of non-commercial sponsors of a research study and the organization of the health system in which the study takes place. Please note that UoA R&I must participate in the development of mNCA for all studies. Please note: The mNCA is a model used to agree on the relationship between and responsibilities of non-commercial sponsors and their research sites in relation to certain studies.

The update replaces the 2008 version, which was revised after consultation. There are several different model conventions and you should use the one that best suits your type of study and sponsorship agreements. For more information, visit the IRAS website. 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. Contracts and agreements should be concluded before the start of the review and be subject to regular review to ensure that they remain up-to-date and relevant. . . .

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