What Is CTMS
The CTMS (Clinical Trial Management System) is the process management system for clinical operations: all operational data of a trial from startup to close-out — sites, teams, subjects, monitoring visits, issues — is registered, moved through workflows, and summarized here.
eTMF manages documents; CTMS manages processes. Both work together in the same Clinical Operations Vault on the same study hierarchy: document filing via eTMF, process tracking via CTMS.
The Seven-Stage Loop
Core CTMS usage can be summarized in seven stages:
| Stage | Meaning | Features involved |
|---|---|---|
| Start | Study activation, recruitment planning | Study lifecycle, enrollment metrics, Metrics Over Time |
| Sites | Country/site lifecycle and exception paths | Qualify / Select / Initiate Site |
| Team | Study team and communication | Study Person, Team Role, Grant Access |
| Subjects | Screening, enrollment, withdrawal | Subjects, Subject Visits |
| Monitor | Monitoring visit lifecycle | Monitoring Events (PSV/SIV/IMV/COV) |
| Deviate | Protocol deviation / observation closure | Issues, Observations, Protocol Deviations |
| Dashboards | Operational dashboards | Study Management Homepage, CRA Homepage |
The Shared Study Hierarchy
Process data lives under the same three-level structure: Study → Study Country → Study Site. Differences from eTMF:
- Milestones expand only when the study reaches Planning; sites can only be initiated (Initiate Site) after the study is Active.
- A site can only enter Initiating after its parent Country has run Select Country — CTMS site activation must follow the lifecycle, not just record creation.
A Typical Journey
`` Start → Create study + Plan Study + enrollment metric Planned + Ready to Enroll (Active) Sites → Country Select Country; Site Qualify → Select → Initiate (Active) Team → Study Persons onboarded (Study Manager / Contributor / CRA) Subjects → Consented → In Screening → Enrolled Monitor → Monitoring Event: Expected → Planning → Confirmed → In Progress → Final Deviate → Protocol Deviation / Observation closure Dashboards → Both homepages scoped by study/country/site ``
Required Permissions & Roles
| Permission set / role | Positioning |
|---|---|
| Study Manager | Study manager: study lifecycle, recruitment planning, team |
| Clinical Research Associates | CRA: monitoring visits, site day-to-day |
| Central Monitor | Central monitoring: CRA capabilities plus the central monitoring view |
| Clinical Business Administrator | Business admin: study configuration and directory maintenance |
Permissions have two layers: the Security Profile / permission set determines which actions you can perform; Team Role + Grant Access (study team) determines which studies' data you can see.