Last Patient In (Milestone)

 

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Description

The LPI milestone marks when the final patient has been enrolled and completed their first protocol-defined visit in a clinical trial.

Specifically:

  • Enrollment is complete for the study.
  • Following LPI, any patients who dropped out early will continue to be followed for safety and data collection per the protocol. But no new patients may be added.
The LPI milestone is a key process point that transitions a trial from active recruitment into end-of-study activities and should be clearly defined in the process flow.

Metrics Considerations

DCT KPIs

LPI Data is used to calculate recruitment rates, and is used to determine time to database lock.