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.