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Setting up and running a clinical research study

If you are undertaking clinical research in the NHS, you will need to:    

  • Have a well-defined study and a protocol and be able to meet the costs
  • Have an institution to sponsor your study (UH Bristol, other NHS Trust or University)
  • Gain all regulatory approvals (e.g. HRA, REC, MHRA etc) via the IRAS system
  • Work with participating sites to arrange confirmation of capacity and capability

More details are provided in the sections below, but please contact us early on so we can go through the process with you, and answer your questions.

Developing your research protocol
Guidelines on writing a protocol.
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Funding
Find out about ensuring the research costs are met.
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Obtaining sponsorship for research studies
Find out why you need a sponsoring organisation, and how to obtain sponsorship.
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The application process using IRAS and HRA approval
Find out more about applying for ethcis, R&D approval, MHRA etc via the combined IRAS system.
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What to do when approval is received
Patient recruitment, safety reporting, monitoring, amendments, site files, archiving.
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SOPs, Templates and Guidance
Our standard operating procedures, templates and guidance documents.
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