Central Monitoring & Key Risk Indicators
How centralized review complements site monitoring, and what its signals mean for the records you keep.
- Explain how central monitoring can complement site review
- Distinguish a key risk indicator from a quality tolerance limit
- Keep site records that read cleanly to a central reviewer
ICH E6(R3) describes monitoring as a broad range of activities. Sponsors tailor the approach to the trial’s design and identified risks, using site, remote, and centralized monitoring as appropriate.
Centralized monitoring evaluates accumulated data in a timely way. It can reveal systemic or site-specific issues, complement site monitoring, or help target where closer review is needed.
ICH E6(R3) · §3.10“The sponsor should implement an appropriate system to manage quality throughout all stages of the trial process.”
