Suite object map

The main graph

DevelopmentProgram
└── Study
    ├── Protocol
    │   └── ProtocolVersion
    │       ├── StudyObjective
    │       │   └── Endpoint
    │       ├── StudyPopulation
    │       │   └── EligibilityCriterion
    │       ├── StudyArm / Cohort / Epoch
    │       ├── StudyIntervention
    │       └── ActivityDefinition
    │           └── ActivityPlacement
    │
    ├── StudyCountry
    │   └── StudySite
    │       ├── SiteParticipation
    │       ├── StudyTeamParticipation
    │       ├── ApprovalRequirement
    │       ├── TrainingRequirement
    │       └── SiteActivationDecision
    │
    ├── StudyParticipant
    │   ├── ConsentDecision
    │   ├── ScreeningEpisode
    │   ├── EligibilityDecision
    │   ├── Enrollment
    │   ├── ProtocolAssignment
    │   ├── TreatmentAssignment
    │   ├── ParticipantSchedule
    │   └── ActivityOccurrence
    │       ├── Observation
    │       ├── SpecimenCollection
    │       ├── AssessmentCompletion
    │       ├── Dispensation
    │       └── EvidenceRecord
    │
    ├── OperationalPlan
    ├── MonitoringPlan
    ├── RiskManagementPlan
    ├── DataReviewPlan
    ├── FilingPlan
    └── AnalysisPlan

Seven object families

Family	Foundation object	Important specializations
Study intent	ProtocolVersion	objective, endpoint, eligibility, activity, intervention
Operational scope	StudyScope	Study Country, Study Site, cohort, participant
Parties	Party	Person, Organization, Facility, Principal
Conduct	ActivityOccurrence	encounter, collection, assessment, dispensation
Data	Observation	datapoint, lab result, eCOA response, device measurement
Oversight	Finding and Decision	query, deviation, safety case, review, lock
Evidence	EvidenceRecord	signature, trial artifact, provenance chain, audit entry

How domain extensions work

Foundation objects provide stable meaning. Domain objects extend them through typed specialization or composition.

ActivityDefinition
├── DataCollectionActivity
├── eCOAAssessmentActivity
├── SpecimenCollectionActivity
├── ImagingActivity
├── InterventionAdministrationActivity
└── DispensationActivity

StudySite
├── StartupSiteFacet
├── OperationalSiteFacet
├── EdcSiteFacet
├── SupplySiteFacet
└── TmfFilingScopeFacet

The base object retains the shared identity. Each facet adds its own fields and behaviours.

The most important relationships

• A Study is governed by one or more immutable ProtocolVersion objects over time.
• A ProtocolVersion defines activities; an ActivityPlacement says where and when an activity applies.
• A StudySite connects one reusable Facility to one Study.
• A StudyParticipant represents participation in one Study, not universal personhood.
• An ActivityOccurrence realizes one planned or unplanned activity for a participant.
• An Observation is produced by an occurrence and retains its source and definition.
• A Finding evaluates conduct, data, material, or evidence.
• A Decision resolves a defined question against exact evidence.
• An EvidenceRecord makes an action, occurrence, or decision reconstructable.