Models, guides and information on feedback can be found in the “Models and Accompanying Materials” section on the IRAS help pages. The most fundamental change is that the revised models apply to health services in England, Northern Ireland, Scotland and Wales and replace the 2011 country versions. Therefore, a single standard contract for commercial clinical trials will be possible across the UK, allowing unnecessary administrations to be retired to carry out the same study in the UK. ABPI commented that “the new mCTA has broad support from life science leaders in the UK government for the potential to accelerate innovative research and development.” For HRA-authorized studies, HRA`s initial evaluation letter (and HRA authorization letter) specifies the corresponding agreement for each type of site in a study. The document may refer to the declaration of activity and the timing of events, to a model of agreement (for example. B mCTA) or another sponsor document. 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. 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.
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. 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.