Platform domain model
Boundary
Section titled “Boundary”Platform supplies capabilities common to every vertical. It does not define what a Study Site, Casebook, Monitoring Event, Expected Document or Payable Item means.
| Platform object/service | Responsibility |
|---|---|
PartyDirectory |
stable Person, Organization, Facility and Location identity |
StudyIdentityRegistry |
stable Study/Study Country/Study Site references and aliases |
Document / DocumentVersion / Rendition |
governed content identity, versioning and representation |
ObjectLifecycleDefinition |
permitted states and transitions for configured record types |
WorkflowDefinition / WorkflowInstance / Task |
coordinate human decisions without owning their clinical meaning |
RoleAssignment / AuthorityGrant |
application authority separate from study responsibility |
ControlledTermSet |
versioned terminology and translations |
AuditEntry |
actor, action, affected revision, timestamp, reason and provenance |
ElectronicSignature |
signer, meaning, signed manifest and validity |
NotificationRequest |
delivery request caused by a domain fact |
IntegrationIdentity |
source identity, target identity and mapping history |
Governing rule
Section titled “Governing rule”Platform lifecycle configuration can enforce a vertical’s accepted lifecycle, but configuration is not
the source of that lifecycle’s meaning. StudySiteActivated remains a Study Startup/CTMS fact even
when a platform workflow coordinates its approval.
Evidence crosswalk
Section titled “Evidence crosswalk”| Observed product behaviour | TechSol decision | Difference / question |
|---|---|---|
| Documents and object records have configurable lifecycles | platform enforces a lifecycle definition owned semantically by a vertical | how are incompatible lifecycle revisions migrated? |
| Workflows coordinate tasks, verdicts and state changes | workflow is orchestration; verdict produces a vertical decision | which verdicts require typed domain commands? |
| Document workflows use an envelope and contents | ReviewPackage may coordinate an exact content manifest |
envelope is not automatically a clinical-domain object |