State Flow
A study goes from creation to activation:
| State | Meaning | Key actions |
|---|---|---|
| Candidate | Candidate | Configure + Plan Study |
| Planning | Planning | Milestones and EDL expand |
| Active | Active | Entered via Ready to Enroll; sites can be initiated |
Creating a Study
Open the Studies list → Create, fill in Study Number and Study Phase (e.g. Phase III), and save. The study is created in the Candidate state.
Configuring & Running Plan Study
- Open the study detail page → Study Configuration Details:
- Milestone Master Set and Template EDL are required.
- Recruitment Planning Metrics: check
Screened,Enrolled(optionallyRandomized).- Recruitment Planning Frequency: e.g.
Monthly.- Recruitment Planning Level: e.g.
Study.- Metric Calculation:
Date-Based.
- Metric Calculation:
- Recruitment Planning Level: e.g.
- Recruitment Planning Frequency: e.g.
- Recruitment Planning Metrics: check
- All Actions → Plan Study, fill in Study Start Date, submit. The state becomes Planning; study-level milestones and the EDL are generated.
Filling Recruitment Milestone Dates
Before Enrollment Metrics Over Time can be generated, fill in the finish dates of the paired milestones for each checked recruitment metric:
| Metric | First milestone | Last milestone |
|---|---|---|
| Screened | First Study Subject Screened | Last Study Subject Screened |
| Enrolled | First Study Subject In | Last Study Subject In |
For each milestone: Plan Milestone (if Unplanned) or Edit, and fill in Planned Finish Date.
Note
Last must be ≥ First, otherwise the metric generates no Metrics Over Time. Use the study-level entries, not site-level ones with similar names.
Setting Enrollment Metric Planned Values
The study is seeded with Enrollment Metrics (e.g. Total Screened / Total Enrolled). Open each record → Edit, and set Planned to the target number (e.g. Screened=100, Enrolled=80). Planned > 0 is one of the gates for Metrics Over Time.
Plan Subject Recruitment
Study detail page → All Actions → Plan Subject Recruitment; the Enrollment Metrics Over Time section then shows monthly Screened / Enrolled records. The action is idempotent — running it again adds no records.
Activating the Study
All Actions → Ready to Enroll, submit. The state becomes Active; milestones persist, with new entries like Primary / Final Database Lock typically added. Only after activation can sites run Initiate Site (see Site Lifecycle).
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Plan Subject Recruitment produces no Metrics Over Time | Check the gates: Metric Calculation is Date-Based; recruitment planning config saved; paired milestones have finish dates with Last ≥ First; Total Screened/Enrolled Planned > 0 |
| Enrollment metrics missing | They appear after Plan Study; check the study detail section or Study Management → Enrollment Metrics |
| First/Last Subject milestones missing | Verify Plan Study ran and the state is Planning; use study-level entries |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Study: Create, Read, Edit | Creating studies, maintaining configuration and recruitment planning fields |
| Lifecycle action | Study: Plan Study, Ready to Enroll | Advancing state, generating milestones/EDLs/metrics |
| Object | Milestone: Read, Edit | Filling recruitment milestone finish dates |
| Object | Enrollment Metrics: Read, Edit | Setting Planned values |
| Object action | Study: Plan Subject Recruitment | Generating Metrics Over Time |
Recruitment planning fields require Edit access; read-only roles cannot fill Planned values or milestone dates.