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Focus on Regulation

New UK-Wide Model Clinical Trial Agreements Published

An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK.

The mCTA is a standard form contract which is intended to be used by clinical trial sponsors and NHS/HSC organisations without modification. Previously, under the 2011 version, separate agreements were required for each of the four nations – England, Scotland, Wales and Northern Ireland. The new template enables a single agreement to be used throughout the UK, streamlining the process for companies wishing to conduct clinical trials at multiple sites.

The mCTA for industry-sponsored trials involving Clinical Research Organisations (CRO-mCTA) has also been updated, together with the accompanying guidance for both the mCTA and CRO-mCTA. Both agreements have been amended to reflect changes in legislation and guidance, including the General Data Protection Regulation (EU) 2016/679 and the 2015 ABPI Clinical Trial Compensation Guidelines.

The mCTAs were developed by the UK Government working jointly with the Association of the British Pharmaceutical Industry (ABPI), with input from stakeholders including the Health Research Authority and Medical Research Council. There are also separate model agreements for non-commercial research/investigator initiated trials, collaborative research and trials in primary care settings.

The revised mCTA and CRO-mCTA are available here.