High Compliance Risk

We recommend you take prompt action to review these high risk areas in more detail and put in place mitigation strategies.

• 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.
• A penchant for using easily reported performance metrics that don't reflect the risk profile of this study.
• Issues with how staff turnover was handled both in your core team and at sites.
• Without some remedial action is it highly likely that there will be distinct difficulty in "telling the story of the study" at a future regulatory inspection.