Medium Compliance Risk

It is likely that parts of your study conduct have been good but you may lack reliable evidence to demonstrate this good conduct.

• A high dependency on email for critical elements of study communication.
  
• Demonstrating that sites always accessed the latest versions of documents and forms.
  
• Potential version control and access problems with documents across your study community.
  
• Consistency between what is in site ISFs and your Trial Master File.
  
• Inability to demonstrate consistent practices at sites and by the monitoring team.
  
• Handling of staff turnover.