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New UK-Wide Model Clinical Trial Agreements Published

By Julia Fraser & Jane Summerfield on March 13, 2018
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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.

Photo of Jane Summerfield Jane Summerfield

Partner, London

Jane focuses on regulatory compliance and commercial agreements in the life sciences and food sectors. Jane advises on legal and regulatory requirements that apply during the product lifecycle, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences…

Partner, London

Jane focuses on regulatory compliance and commercial agreements in the life sciences and food sectors. Jane advises on legal and regulatory requirements that apply during the product lifecycle, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences, CE marking, product labelling, product composition, advertising and marketing activities, and pricing and reimbursement. Jane also advises on a wide range of commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements, as well as helping clients to resolve issues with UK enforcement authorities and regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA), Advertising Standards Authority (ASA), Food Standards Agency (FSA) and Trading Standards.
Jane combines commercial acumen with deep regulatory knowledge. She understands the business pressures faced by clients, having provided in-house regulatory compliance and commercial support to a major pharmaceutical client and a multinational food company. Jane provides “clear responses with business impact” Chambers UK.

Read more about Jane SummerfieldEmail
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  • Posted in:
    Administrative
  • Blog:
    Focus on Regulation
  • Organization:
    Hogan Lovells
  • Article: View Original Source

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