Site monitoring
Source data verification and protocol compliance checks, delivered on-site and coordinated with remote monitoring depending on study needs.
What's included
What goes into a routine monitoring visit
- Source data verification against the eCRF, following the monitoring plan's defined SDV scope
- Protocol compliance and informed consent review, checked against the current approved version
- Investigational product accountability and site regulatory file review
- Findings documented for MVR writing and follow-up items tracked to closure before the next visit
Risk-based approaches
Monitoring plans built around risk-based monitoring principles, focusing site visits where the risk to data and patient safety is highest.