CTMS domain model

Product boundary

CTMS owns operational coordination at Study, Study Country and Study Site scope. It tracks plans, milestones, metrics, operational issues and monitoring. Subject/visit records received from EDC or RTSM are operational projections, not a second source of clinical truth.

Object map

Study
├── StudyCountry
│   └── StudySite
│       ├── StudyPerson / StudyOrganization
│       ├── SiteMilestone
│       ├── SubjectOperationalSummary
│       │   └── SubjectVisitOperationalSummary
│       ├── Issue
│       └── MonitoringSchedule
│           └── MonitoringEvent
│               ├── MonitoringActivity
│               ├── MonitoringVisitParticipant
│               ├── MonitoredSubject snapshot
│               ├── MonitoredSubjectVisit snapshot
│               ├── FollowUpItem
│               └── TripReport
├── StudyMilestone / CountryMilestone
├── EnrollmentPlan and Metrics
└── StudyCommunication

Principal behaviours

Aggregate	Commands	Rules
StudyParticipation	include country, add site, change operational state, assign organization/person	country and site must remain in the Study hierarchy
Milestone	plan, forecast, achieve, revise forecast, invalidate actual	scope is exactly Study, Country or Site; planned/forecast/actual dates are distinct
EnrollmentPlan	set target, forecast, record actual projection	actual subject milestones arrive from authoritative conduct systems
OperationalIssue	record, classify, assign, mitigate, close, reopen	observation, protocol deviation and follow-up item remain distinct types
MonitoringSchedule	approve template application, schedule recurring event, adjust window	approved schedule creates events; country override outranks Study template
MonitoringEvent	plan, confirm, conduct, capture snapshot, issue report, follow up, complete	activity and subject snapshots preserve what the monitor knew at visit time

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Shared hierarchy of Study, Study Country and Study Site	canonical operational spine with one stable identity per participation	may a facility have two concurrent Study Sites for distinct departments?
Subject records are typically integration-populated	CTMS owns SubjectOperationalSummary, not Participant or Casebook	which manual corrections are permitted without changing the source?
Monitoring Event contains snapshots of subjects, visits, ICFs, issues and metrics	MonitoringEvidenceSnapshot is immutable visit-time evidence, not a live reference	how are post-visit corrections appended to the report evidence?
Milestones track study/country/site dates and monitoring events	milestone has discriminated scope and optional source occurrence reference	which actual dates are manually decided versus event-derived?
Metrics update after subject/status changes	metrics are dated projections with source and calculation version	what is the canonical as-of and late-arriving-data policy?