Protocol Deviation Rate
Number of protocol deviations per 100 patient visits, measuring trial compliance
What is Protocol Deviation Rate?
Protocol deviation rate is the number of departures from the approved trial plan for every 100 patient visits. It shows how closely a clinical trial is being run to its protocol.
Deviations can affect patient safety and the reliability of results, so a low rate is a sign of well-run trials.
How this KPI is measured
- Function
- Product & Engineering
- Sub-function
- Clinical Trials
- Industry
- Pharma & Life Sciences
- Type
- Lagging
- Impact
- Quality
- Unit
- rate/100 visits
- Measurement frequency
- Monthly
- Formula
- (Protocol deviations / Total patient visits) × 100
How to calculate it
Divide protocol deviations by total patient visits, and multiply by 100.
For example, if there were 45 deviations across 1,500 visits, the rate is 3 per 100 visits.
Classify deviations by severity and cause, such as missed assessments or out-of-window visits, and track by site to target support and retraining.
Where it is used
Protecting patient safety and data quality
Spot problems early.
Managing sites
Target support.
Preparing for inspection
Show control.
How to improve it
Tips and common mistakes
- Report important deviations as required by regulation.
- Complex protocols cause more deviations.
- Look at severity, not only count.
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