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The monitoring of research in the NHS is an essential process to ensure that patient/participant safety is maintained throughout and that there is accurate reporting of results at its conclusion.

Under the UK Policy Framework for Health and Social Care Research and Good Clinical Practice (GCP) guidelines, UH Bristol has a responsibility to:

(i)  Monitor research conducted on its premises  

(ii) Monitor research which it sponsors

If your study is identified for monitoring, you will be contacted by a member of the monitoring team to arrange a visit. Monitoring can be in the form of (but is not limited to):

  • Self-monitoring
  • Site file review
  • Protocol compliance
  • Review of data for first patient recruited
  • Close out visit
  • Consent process 

If you would like to know more about our monitoring process and what to expect at a visit, please refer to our monitoring procedure SOP 014 Monitoring and Oversight of Research.

If your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP) or a device trial, it may also be identified for inspection by the Medicines and Healthcare products Regulatory Agency (MHRA). Further information on your responsibilities can be found in our SOP 008 Investigator Oversight of Research.