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Â鶹´«Ã½ÊÓƵÍøÕ¾ researchers with studies which fall outside of these categories should consult withÌýÂ鶹´«Ã½ÊÓƵÍøÕ¾ ethics.

There are typically four stages of approval that must be considered and in place before conducting a clinical research project:

• Grant Applications
• Sponsorship
• Regulatory Approvals
• NHS Site Assess, Arrange and Confirm

The Joint Research Office willÌýsupport Â鶹´«Ã½ÊÓƵÍøÕ¾ and Â鶹´«Ã½ÊÓƵÍøÕ¾H researchers through the stages and approvals required to obtain any of these approvals:

• HRA approval
• NHS ethics approval
• MHRA approval
• CAG approval
• Permission to start at Â鶹´«Ã½ÊÓƵÍøÕ¾H

In some cases, a study will require a sponsor’s legal representative in the UK (Clinical Trials with a sponsor outside of the UK) or for some medical devices, a designated UK Responsible Person.

A description of the responsibilities and requirements of each can be found on the .

Studies which require Sponsorship, a Legal Representative or other UK responsible person or organisation should follow the guidance on grant applications and sponsorship.

Studies which require NHS Site Assess, Arrange and Confirm approval at Â鶹´«Ã½ÊÓƵÍøÕ¾H should follow the guidance set out here.

Studies which use anonymous data from Â鶹´«Ã½ÊÓƵÍøÕ¾H (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by Â鶹´«Ã½ÊÓƵÍøÕ¾ or Â鶹´«Ã½ÊÓƵÍøÕ¾H only. See our Data pathways at Â鶹´«Ã½ÊÓƵÍøÕ¾H webpageÌýfor further information on the DAP-R and accessing data at Â鶹´«Ã½ÊÓƵÍøÕ¾H.

Many studies will require statistical involvement. To find out about statistical support for research studies visit the Biostatistics group page.