Milestone Tracking
Study Management → Milestone Tracking lists all study milestones (the Milestone object, shared with eTMF); study managers track key study nodes here:
| Column | Meaning |
|---|---|
| Milestone | Milestone name (from template) |
| Study / Study Country / Study Site | Owning level |
| Milestone Type | e.g. First Subject In (FSI), Database Lock |
| Baseline / Planned / Actual Finish Date | Baseline, planned, and actual finish dates |
| % Complete / Completeness | Completeness (auto-computed, icon) |
| Completed EDL Item Records | Count of completed expected-document entries |
Milestones are generated automatically by Plan Study from the master set (initial state Unplanned); countries/sites get their own milestones when entering Initiating. To schedule and complete:
- Plan Milestone: set Planned Finish Date; downstream dependency dates follow; state → Planned.
- Mark Complete: set Actual Finish Date; state → Complete.
Note
The dependency gate is enforced server-side: Mark Complete on a downstream milestone is rejected while the upstream is incomplete, unless a Gating Override Date is set.
Completeness is computed from "previous milestones complete + required tasks complete + expected documents collected and approved"; use View Expected Documents to see linked EDL Items. See Milestones for the full state flow.
Enrollment Metrics
Study Management → Enrollment Metrics maintains enrollment metrics per level (the Metric object). When a study enters Planning/Active — or a country/site enters Initiating — the system seeds one record per metric (initial value 0), in three level-based types:
| Type | Level |
|---|---|
| Study Metric | Study |
| Study Country Metric | Study Country |
| Study Site Metric (default) | Study Site |
Metric Type has 11 values: Total In Screening, Total Screened, Total Screen Failed, Total Enrolled, Total Withdrawn, Total Completed, Enrollment Rate (subjects per month), Screen Failure Rate (%), Drop Out Rate (%), Total Randomized, Total End of Treatment.
Maintenance is manual: fill Planned, Forecast, and Actual; Planned Roll Up aggregates children's Planned automatically.
Note
The study's Metrics Not In Use setting trims which metric types get seeded and removes them from the homepages.
Metrics Over Time
Run the object workflow from study/country/site detail pages (All Actions, e.g. Create Metrics Over Time) to generate per-period planned/actual/forecast records at the Recruitment Planning Frequency (default monthly). Gates:
- The study's Metric Calculation is Date-Based;
- The paired recruitment First/Last milestones have end dates (Last ≥ First);
- The metric's Planned > 0.
The generated trend overlays the Study Management Homepage Enrollment Status chart (Study/Country levels only; site enrollment is tracked in the subject list).
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Milestone Tracking is empty | Run Plan Study and advance to Planning; countries/sites must enter Initiating |
| Metrics Over Time fails | Check the three gates: Date-Based, First/Last milestone dates, Planned > 0 |
| Enrollment Status chart is empty | The chart shows Study/Country levels only; confirm enrollment_status and metrics_over_time data exist |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Milestone: Read, Edit | Viewing and scheduling milestones |
| Lifecycle actions | Milestone: Plan Milestone, Mark Complete | Scheduling and completion |
| Object | Metric: Create, Read, Edit | Maintaining Planned / Forecast / Actual |
| Object action | Metric: Create Metrics Over Time (study/country/site) | Generating period trend data |
CTMS Study Manager, CRA, and Central Monitor maintain metrics and milestones; CTMS Business/System Administrators additionally hold delete and workflow execution rights.