55 Delivery Metrics & KPIs
55.1 Purpose
Metrics and KPIs provide quantitative visibility into trial performance.
They allow project management to: - detect problems early, - track trends, - and justify decisions.
Without metrics, PM is blind.
55.2 Key Performance Domains
Typical KPI categories:
| Domain | Examples |
|---|---|
| Start-Up | % sites activated |
| Monitoring | Visit completion rate |
| Safety | SAE reporting timeliness |
| Data Quality | Query aging |
| Quality | Deviation rate |
| Delivery | Milestone adherence |
55.3 Examples of Operational KPIs
55.3.1 Monitoring
- % scheduled visits completed
- average days to report findings
55.3.2 Data Quality
- open queries per subject
- median query resolution time
55.3.3 Safety
- % SAEs reported within 24 hours
- unresolved safety follow-ups
55.3.4 Quality
- deviations per site
- CAPA closure time
55.4 Leading vs Lagging Indicators
| Type | Meaning |
|---|---|
| Leading | Predict future problems |
| Lagging | Confirm past performance |
Examples: - High query aging → leading indicator
- Missed DBL → lagging indicator
Effective PM prioritizes leading indicators.
55.5 KPIs as Decision Inputs
Metrics are not for reporting. They are for decision-making.
KPIs inform: - resource reallocation - escalation - vendor performance - risk prioritization
KPIs are a control system, not a scoreboard.