High Compliance Risk
We recommend you take prompt action to review these high risk areas in more detail and put in place mitigation strategies.
Likely areas for concern and remedial action will be:
- 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.