51 Trial Planning & Milestones
51.1 What is Being Planned?
In clinical trials, the “project” is the delivery of evidence.
The primary planning objectives are:
- activate sites,
- enroll subjects,
- generate clean data,
- analyze outcomes,
- deliver regulatory-grade results.
51.2 Major Trial Milestones
Typical high-level milestones:
| Milestone | Meaning |
|---|---|
| FSI | First Site Initiated |
| FPI | First Patient In |
| LPI | Last Patient In |
| LPLV | Last Patient Last Visit |
| DBL | Database Lock |
| CSR | Clinical Study Report |
These milestones define the critical path of the trial.
51.3 Critical Path Concept
The critical path represents: > the sequence of activities that determines the earliest possible > completion date of the trial.
Common critical path blockers: - slow site activation - poor enrollment - delayed monitoring - unresolved data queries - late safety reporting
51.4 Dependencies
Many tasks depend on others:
| Task | Depends On |
|---|---|
| Monitoring | Site activation |
| Enrollment | IRB approval |
| Database lock | Query resolution |
| CSR | Final analyses |
PM’s role is to identify and manage these dependencies.
51.5 What Does “On Track” Mean?
A trial is considered “on track” when:
- milestones are met on time,
- risks are controlled,
- data quality is acceptable,
- safety reporting is timely,
- and no unresolved critical issues exist.
“On track” is not just schedule — it is system health.