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Starting a new study?

Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø researchers with studies which fall outside of these categories should consult withÌýÏã¸ÛÁùºÏ²ÊÖÐÌØÍø ethics.

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

The Joint Research Office willÌýsupport Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø and Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH 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 Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH

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 Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH should follow the guidance set out here.

Studies which use anonymous data from Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø or Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH only. See our Data pathways at Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH webpageÌýfor further information on the DAP-R and accessing data at Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH.

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

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