Planning & Funding: Confirm sponsor(s)

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Introduction

A Sponsor(s) is required for all studies that fall within the scope of the UK policy framework for health and social care research (see 1st resource). For a Clinical Trial of an Investigational Medicinal Product, the sponsor(s) must meet legal requirements, these are outlined in the Clinical Trials Toolkit, Confirm sponsor station.

At this stage in the planning process, discussions with potential sponsoring organisations should have taken place and arrangements should now be finalised. It is common for sponsoring organisations to issue a letter of sponsorship to the lead investigator. This should be retained as part of the study file.

Funders may require notification of the organisation(s) sponsoring the study. Research Ethics Committees and NHS and University R&D departments will need to know who is sponsoring the study and are likely to request a copy of the sponsorship letter.

More information on sponsorship responsibilities is available from Discuss sponsorship and agreements.

Resources

  • 1. UK policy framework for health and social care research

    The UK policy framework for health and social care research (which replaces the 4 Research Governance Frameworks of England, Wales, Scotland and N. Ireland) is available to download from this site.

    Good practice for specific research projects Date added: 4 September 2007