The Clinical Trial Agreement for biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly active general practitioners, the British Medical Association, the Protection Medical Society and UK health authorities. The Health Research Authority (HRA) supports the application of standard agreements. Before a clinical trial can begin, it is important to have an agreement between the parties defining the responsibilities and commitments. In the United Kingdom, where the clinical trial is conducted in the NHS, different types of agreements, including MTIIs, have been developed in the form of a standard form contract, accepted by both the pharmaceutical industry and NHS bodies. The goal is to simplify and accelerate the launch of studies on NHS patients in NHS hospitals. Models must be used without modification, with the exception of test-specific information. In practice, MCCs are considered standard models and it is difficult for the industry to propose changes without significantly increasing costs. If you are applying for HRA authorization for your study, you may also find it useful to refer to the standard document and HRA evaluation criteria, as this includes reflections on the use of model agreements. You can find the document on our HRA special approval page.
If there is an agreement between the proponent and the site (including all commercially sponsored studies), it is highly recommended to use an unchanged model agreement. These agreements should be used as outlined in their accompanying guidelines. The use of the unchanged model agreement simplifies and speeds up the process of setting up the study. The UK Clinical Research Collaborations (UKCRC) model agreements have been negotiated with English law, and governance agreements in their key versions and modified versions are available for use in legal systems and administrative arrangements in Scotland, Wales and Northern Ireland. The use of a modified model agreement or an agreement not based on a model model is possible, but the proponent should be aware of any difficulties that may arise frequently, such as longer negotiating times. B and the risk that the study could not be carried out if certain conditions could not be agreed with the participating organizations. The MCTA has also been updated for industry-supported clinical research studies (CRO-mCTA), along with the accompanying guidelines for MCTA and CRO-mCTA. Both agreements have been amended to reflect changes to legislation and guidelines, including the General Data Protection Regulation (EU) 2016/679 and the ABPI guidelines for compensation for 2015 clinical trials. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations. Appropriate data processing agreements should be put in place using the appropriate modelling agreement: MICRA was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council.