Site & Investigator Intelligence domain model

Product boundary

Site & Investigator Intelligence owns curated global reference identity and managed attributes for investigators and institutions. CTMS/Startup owns their participation in a specific Study.

ClinicalOrganization
├── CuratedOrganizationIdentity
├── OrganizationLocation
└── OrganizationRelationship

ClinicalPerson
├── CuratedPersonIdentity
├── Specialty
└── PersonOrganizationAffiliation
    └── ContactPoint

ReferenceDataChangeRequest
└── CurationDecision

Key rules

• Curated identifier is distinct from user identity and from a study-specific role.
• One investigator can have multiple organization affiliations and contact points.
• One preferred affiliation can be selected without deleting the others.
• Curated attributes are updated through sourced refresh or accepted change request, not local overwrite.
• StudySite references an eligible Institution; it does not copy the institution’s identity.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Curated ID links Person and Organization records	CuratedPartyIdentity is separate from local, user and study identities	how are duplicate local parties merged without breaking study references?
Investigators may have multiple affiliations/contact records	affiliation is an effective relationship, not a field on Person	what evidence determines effective dates and primary affiliation?
Curated fields refresh and local users submit change requests	managed attributes change only through sourced revision or curation decision	which attributes can remain locally governed?