Certified before, not caught up during
Training is tracked to completion before start-up ends, so conduct doesn't open with unresolved certification gaps for an inspector to find.
What's included
What gets tracked before the study starts
- GCP training requirements confirmed for every role identified in the study quality plan
- Study-specific SOP training assigned and completed ahead of site activation
- Certification records collected and verified, with expiry dates flagged for renewal
- Training gaps escalated and resolved before a site or vendor is cleared to start work
- A certification tracker maintained as the single record referenced during audits and inspections
- The tracker handed off into conduct, where it's kept current through external SOP training and familiarization
One tracker, the whole study
The same certification record continues into conduct through SOP training and familiarization, so there's no gap between start-up training and ongoing training.