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Study management

The following SOPs address particular aspects of study management during recruitment, participant follow up and data analysis.  If you are a CI/PI for a study which falls under the clinical trial regulations, it is particularly important you are familiar with arrangements for reporting adverse events and breaches.

  • Research Training (SOP_007) 
  • Research Safety Reporting (SOP_009)
  • Monitoring and Oversight of Research (SOP_010)
  • Study Data (SOP_012)
  • Essential Research Documents (SOP 014)
  • Managing Breaches (SOP_018)
  • UH Bristol sponsored research amendments (SOP_019)
  • UH Bristol Hosted Research Amendments (SOP_020)
  • Investigator Oversight (SOP_008) - this SOP provides an overview of the responsibilities of the CI/PI and is applicable to all stages of a research study.  It is essential reading for all CIs and PIs.

Full list of SOPs available here.  Also refer to guidance documents, work instructions and templates.