Ownership and contracts

Ownership rule

One context owns the authoritative meaning and permitted transitions of each object. Other contexts may keep a reference or consume an outcome, but cannot silently acquire ownership.

Owning context	Owns	Does not own
Study Definition	StudyVersion, design, arms, epochs, encounters, activities, criteria	Site execution or collected participant data
Study Operations	Study, StudyCountry, StudySite, milestones, operational status	Protocol content or EDC values
Site Startup	feasibility, submissions, approvals, activation package, readiness decision	Facility identity or general document content
Participant Conduct	participant identity within study, consent, eligibility, enrollment, disposition	CRF design or supply inventory
Clinical Data	casebooks, visit/form instances, data points, queries, review, freeze and lock	CTMS site lifecycle or payment terms
Randomization & Supply	randomization decision, treatment assignment concealment, kits, inventory, dispense	Participant eligibility or adverse-event assessment
Monitoring	monitoring plan, visit, activity, finding, follow-up action, report completion	Source data value or TMF filing taxonomy
Essential Records	artifact expectations, essential record, filing, quality decision, finality	The operational act evidenced by a record
Safety	adverse event, seriousness, expectedness, causality, case, reporting decision	EDC query lifecycle
Quality & Risk	risk, issue, CAPA, audit, inspection commitment	Routine monitoring findings before promotion
Site Payments	agreement schedule, payable item, invoice, payment decision	Clinical occurrence that triggers eligibility
Party & Responsibility	organization, person, facility, role, delegation, responsibility	Application authorization

Published cross-context facts

Fact	Publisher	Consumers	Minimum payload
StudyVersionApproved	Study Definition	Operations, Startup, EDC, Supply, TMF	study, version, approval date
StudyVersionAdopted	Study Operations	Startup, Participants, Monitoring	study, version, effective scope
StudySiteActivated	Site Startup	CTMS, EDC, Recruitment, Supply, TMF	site, governing version, decision time
SiteEnrollmentSuspended	Study Operations	Recruitment, Participant Conduct	site, effective time, reason category
ParticipantEnrolled	Participant Conduct	CTMS, EDC, RTSM, Payments	participant, site, version, date
ParticipantRandomized	Randomization	EDC, CTMS, Supply	participant, stratum, arm reference, time
SubjectVisitOccurred	Clinical Data / eCOA	CTMS, Monitoring, Payments	participant, visit definition, occurrence date, status
ProtocolDeviationConfirmed	Deviation Management	CTMS, Monitoring, Safety, TMF	occurrence, rule, classification, participant/site scope
MonitoringVisitCompleted	Monitoring	CTMS, TMF, Quality	visit, site, report evidence, completion time
EssentialRecordFinalized	Essential Records	Inspection Readiness	artifact, filing scope, document version, finality
PayableItemEarned	Site Payments	Finance interface	site, participant occurrence, amount basis
SafetyCaseReportable	Safety	Regulatory reporting, TMF	case, authority scope, due date

Rules for consumers

• A consumer may translate terminology, but must retain source identity and version.
• A consumer may derive a local projection, but cannot emit a conflicting authoritative fact.
• A correction is a new fact that identifies what it corrects; it is not silent replacement.
• Cross-context references use stable identity, never a display label such as site number alone.
• A published fact carries clinical occurrence time separately from publication time.

Product projection cross-check

Product-facing record	Authoritative source	What the product may decide
CTMS Subject	Participant Conduct / EDC / RTSM	operational projection, milestone status and monitoring snapshot—not clinical values
CTMS Subject Visit	EDC/eCOA occurrence	operational status, monitoring/payment projection—not source occurrence correction
EDC Site	CTMS/Startup Study Site	entry permission, EDC lock and local collection settings—not site selection/activation
EDC Subject	EDC Casebook creation or RTSM screening connection	EDC collection identity and status rule projection—not randomization decision
Data Quality harmonized record	EDC/eCOA/RTSM/Lab source snapshot	mapping, review, discrepancy and release—not source overwrite
Payments payable activity	CTMS/EDC authoritative visit/procedure/site event	fee evaluation, payable adjustment and request—not clinical occurrence
eTMF Expected Document	eTMF plan plus milestone/person/organization/product facts	requiredness, expected count, matching and completeness
Site Collaboration Document Request	sponsor/site exchange conversation	requested action, delivery, response and reconciliation—not TMF acceptance
Study Training assignment	role/responsibility plus approved curriculum/material version	applicability, due date, completion and qualification evidence
Disclosures study/country data	CTMS and regulatory master data	obligation, disclosed version, validation, approval and registry submission
RTSM Subject	screening/enrollment input plus RTSM transaction history	randomization, concealment, kit assignment and supply activity
eCOA Participant	CTMS/RTSM participant provisioning	assessment scheduling, respondent access, completion and adherence

The word “Subject” appearing in CTMS, EDC, RTSM and eCOA does not imply four authoritative subject entities. Each product holds a role-specific record or projection around one study-scoped participant identity and publishes only the decisions it owns.