Party and Study Site

Category: Entities and contextual relationships
Review status: Proposed

Foundation objects

Object	Meaning
Person	Real-world individual where lawful and necessary
Organization	Legal or operational organization identity
Facility	Physical or virtual location operated by an Organization
Principal	Human or system identity capable of authenticated action
StudyPartyParticipation	Effective responsibility held by a Person or Organization
StudySite	One Facility’s identified participation in one Study
StudyTeamParticipation	A Person’s operational responsibility in a Study scope
DelegationOfDuty	Investigator-authorized delegation of a study duty

Important distinctions

Organization   != sponsor, CRO, site, or vendor
Facility       != Study Site
Person         != Principal
Responsibility != application authority
Qualification  != delegation
Delegation     != completion of work

Sponsor, CRO, investigator, laboratory, and vendor are roles established through participation—not permanent subtypes of an Organization or Person.

Study Site fields

Field	Type	Meaning
identity	StudySiteIdentity	Stable identity within the Study
study	StudyReference	Study in which the Facility participates
facility	FacilityReference	Reusable real-world facility identity
country	StudyCountryReference	Country participation containing the site
siteNumber	StudySiteNumber	Study-specific operational identifier
investigatorHistory	InvestigatorAssignment[]	Investigator responsibility over time
selectionHistory	SiteSelectionDecision[]	Selection and deselection decisions
activationHistory	SiteActivationDecision[]	Activation decisions and conditions
enrollmentAvailability	EnrollmentAvailability	Whether enrollment is currently permitted

Study Site behaviours

• Nominate for feasibility
• Select for startup
• Begin startup
• Assign principal investigator
• Assess readiness
• Activate
• Open for enrollment
• Suspend or resume enrollment
• Replace investigator
• Close or terminate participation

Rules

• A Study Site connects exactly one Facility to one Study participation.
• Study-site identity survives investigator replacement and site-number correction.
• Site selection, activation, opening for enrollment, and product readiness are different decisions.
• Business responsibility does not grant software authority.
• Closing a site preserves participant, monitoring, data, and evidence history.

Product questions

• Can one Facility host multiple operational Study Sites for the same Study?
• Who owns the final decision to open enrollment?
• Which conditions suspend enrollment without deactivating the site?
• Does investigator replacement create a new participation or revise the existing one?