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Monitoring

Under the Research Governance Framework for Health and Social Care, UH Bristol has a responsibility to monitor research studies conducted on its premises and under Good Clinical Practice (GCP) to monitor studies which it sponsors.

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

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

The monitoring SOP document can be found here: Monitoring Research Studies

If your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP) or device trial it may be identified for inspection by the MHRA. Further information on your responsibilities can be found in our 'Investigator Oversight of Research' and 'Gaining and maintaining authorisations' SOPs.