Site State Main Path
| State | Meaning | Key actions |
|---|---|---|
| Candidate | Candidate | Qualify Site / Place Site on Hold / Site Will Not Participate |
| Qualifying | Qualifying | Select Site |
| Initiating | Initiating | Initiate Site (requires parent Study to be Active) |
| Active | Activated, can enroll | Day-to-day operations |
Creating & Selecting a Country
- Study Countries → Create: select the Study and Country, save (state Candidate, Name auto-generated).
- Open the country detail page → All Actions → Select Country, fill in Country Selected Date, submit. The state becomes Initiating; country-level milestones can be generated.
Note
A site can only enter Initiating if its parent Country is not Candidate — CTMS site activation must follow this lifecycle, not just record creation.
Main Path: Candidate → Qualifying → Initiating → Active
| Step | Action | Result |
|---|---|---|
| 1 | Study Sites → Create: Study Site Number = Site-001, Study Country = the country record; leave Study Number blank (derived automatically) | State Candidate |
| 2 | All Actions → Qualify Site | State Qualifying; site-level milestones can be generated |
| 3 | All Actions → Select Site, fill in Site Selected Date | State Initiating |
| 4 | Confirm the parent Study is Active → All Actions → Initiate Site | State Active |
Exception Path: On Hold
Run Place Site on Hold on a Candidate site, fill in the hold reason (e.g. PI on medical leave); the state becomes Qualifying Hold. To resume, run Remove Site Hold — the site returns to Qualifying and can continue Select / Initiate.
Exception Path: Will Not Participate
Run Site Will Not Participate on a Candidate site, fill in Reason / Notes (e.g. Imaging capability insufficient); the state becomes Not Selected.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Qualify Site fails | The parent Study must not still be Candidate; run Plan Study first |
| Select Site / Initiate Site fails | The Country must run Select Country first; Initiate Site requires the parent Study to be Active |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Study Country / Study Site: Create, Read, Edit | Creating countries and sites |
| Lifecycle action | Study Country: Select Country | Country selection (prerequisite for site activation) |
| Lifecycle action | Study Site: Qualify Site, Select Site, Initiate Site, Place Site on Hold, Remove Site Hold, Site Will Not Participate | Main path and exception paths of the site lifecycle |
Note the lifecycle gates: Initiate Site requires the parent Study to be Active and the parent Country to have completed Select Country.