The Three-Level Structure
All documents, milestones, and quality records of a clinical trial are organized under a three-level structure: Study → Study Country → Study Site.
| Level | Object | Purpose |
|---|---|---|
| Study | Study | Carrier of the trial backbone; its lifecycle drives milestone and EDL generation |
| Study Country | Study Country | Scopes documents and milestones by country |
| Study Site | Study Site | Filing location for site-level documents |
Note
Milestones and Expected Document Lists (EDLs) are only generated after the study reaches the Active state.
Creating a Study
- Log in, select your Vault, open Study Info → Studies, and click Create.
- Fill in Study Number and Study Phase (e.g.
Phase III), then save.
The study is created in the Candidate state.
Configuring and Activating a Study
Two steps take a study from Candidate to Active:
| Action | Steps | Result |
|---|---|---|
| Configure | In Study Configuration Details on the study detail page, select Milestone Master Set and Template EDL | Configuration saved |
| Plan Study | All Actions → Plan Study, fill in Study Start Date, submit | State becomes Planning; milestones and expected documents are generated automatically |
| Ready to Enroll | All Actions → Ready to Enroll, submit | State becomes Active |
Afterwards, the Milestones list and Expected Documents list appear on the study detail page.
Note
If Plan Study is unavailable, verify that Milestone Master Set and Template EDL are filled in.
Creating a Study Country
Open Study Info → Study Countries and create:
| Field | Notes |
|---|---|
| Study Number | Select the parent study |
| Country | Select the country (e.g. United States) |
| Study Country Name | Auto-generated after selecting Country; no manual entry needed |
Creating a Study Site
Open Study Info → Study Sites and create:
| Field | Notes |
|---|---|
| Study Site Number | Site number (e.g. Site-001); Name is this same field |
| Study Country | Select the parent study country |
| Study Number | Leave blank — derived automatically from the Study Country |
After saving, open the site detail page and confirm that Study Number points to the parent study automatically.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| No Name field when creating a Study | The field is labeled Study Number |
| Study Country Name is read-only | It is auto-generated after selecting Country |
| No Site Number field | Name and Site Number are one field: Study Site Number |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Study / Study Country / Study Site: Create, Read, Edit | Creating studies, countries and sites, maintaining fields |
| Lifecycle action | Study: Plan Study, Ready to Enroll | Advancing study state, generating milestones and EDLs |
| Lifecycle action | Study Country: Select Country | Selecting the country (prerequisite for CTMS site activation) |
Clinical Application Administrator has all of the above; Document Contributor is read-only on the study hierarchy and cannot create or advance lifecycles.