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.
Likely areas for improvement 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.
- Handling of staff turnover.