Last Patient Out (Milestone)

Description

The LPO milestone indicates when the final patient enrolled in a clinical trial has completed their last scheduled study visit and procedures.

Specifically:

• LPO marks when the last participating patient has finished all protocol-defined activities, including any follow-up visits for safety evaluations.
• After the last patient finishes the final study visit in the protocol, no more participant study data is expected to be collected. In some cases, the last patient out will also be the last patient enrolled (LPI). But LPO may occur weeks or months after LPI if the last enrolled patient has a long follow-up.
• Achieving LPO means all patients have completed the interventional portion of the trial and only data cleaning activities remain.
• Following LPO, the database can theoretically be locked after all data is entered and queries are resolved according to the protocol timeline.
• Tracking to LPO is a key milestone showing the clinical conduct portion of the trial is fully complete so database lock and analysis can proceed.
• LPO signals the trial is in its final close-out phase with all participant visits complete.
• The LPO milestone marks the true end of patient participation and should be clearly documented in the clinical trial process map or flow.