Canonical object catalog

This catalog is deliberately opinionated. Each row is either a proposed entity, value object, decision, policy, or evidence object. Similar-looking objects remain separate when their identity, owner, or lifecycle differs.

Study definition and planning

Object	Kind	Identity / key	Principal behaviour
Study	Entity	stable clinical undertaking	adopt an approved version; include a country; close conduct
StudyVersion	Entity	study + governed version identity	approve, supersede, withdraw
StudyDesign	Entity	version-scoped design identity	define populations, arms, epochs, cells and schedule
StudyObjective	Entity	objective identity within version	classify as primary, secondary or exploratory
StudyEndpoint	Entity	endpoint identity within version	connect objective, assessment and analysis timing
StudyPopulation	Entity	population identity within design	govern eligibility criteria
EligibilityCriterion	Entity	criterion identity within version	classify inclusion/exclusion and evaluation rule
StudyArm	Entity	arm identity within design	define planned intervention sequence
StudyEpoch	Entity	epoch identity within design	order periods of planned conduct
StudyCell	Entity	arm × epoch intersection	assign planned elements
EncounterDefinition	Entity	planned encounter identity	define timing, window, activities and conditionality
ActivityDefinition	Entity	reusable version-scoped activity	define expected procedure or assessment
ScheduleTimeline	Entity	timeline identity within design	order encounters and timing anchors
StudyIntervention	Entity	intervention role within study	connect product, dose strategy and arm use

Operational participation and startup

Object	Kind	Identity / key	Principal behaviour
Country	Reference entity	governed country code	supply jurisdictional identity
StudyCountry	Entity	study + country participation	plan, submit, approve, activate, close
Facility	Entity	real-world facility identity	correct address/name; relate departments
StudySite	Entity	facility participation in study	select, enter startup, activate, suspend enrollment, close
SiteFeasibilityAssessment	Decision	assessment identity	recommend select / do not select with evidence
RegulatorySubmission	Entity	submission to authority/committee	assemble, submit, answer, receive decision
Approval	Entity	decision by authority/committee	become effective, expire, suspend, withdraw
SiteActivationPackage	Entity	site + activation attempt	collect readiness criteria and evidence
SiteReadinessDecision	Decision	decision occurrence	declare ready or not ready against named criteria
MilestoneDefinition	Definition	type identity	define meaning and required evidence
Milestone	Entity	planned/actual occurrence in scope	forecast, achieve, revise forecast, invalidate achievement
StudyTeamAssignment	Entity	person/organization + study scope	assign and end operational role
ResponsibilityAssignment	Entity	responsibility + accountable party + scope	transfer and accept responsibility
SiteDelegation	Entity	person + delegated task + site scope	authorize, suspend, end

Participant conduct

Object	Kind	Identity / key	Principal behaviour
Participant	Entity	study-scoped participant identity	consent, screen, enroll, randomize, dispose
ConsentFormVersion	Definition	consent document + version	approve for use in jurisdiction/site scope
ConsentDecision	Decision	participant + decision occurrence	consent, decline, withdraw by scope
EligibilityAssessment	Decision	participant + protocol version + assessment	decide eligible, ineligible or undetermined
Enrollment	Decision	participant enrollment occurrence	enroll under effective consent/version/site permission
Randomization	Decision	participant randomization occurrence	assign concealed treatment according to design
TreatmentAssignment	Evidence-bearing value	randomization identity	reveal only under permitted unblinding decision
SubjectVisit	Entity	participant + encounter occurrence	schedule, start, complete, miss, repeat, cancel
ProcedureOccurrence	Entity	participant + activity occurrence	record performed, not done, partial or unknown
ParticipantDisposition	Decision	disposition occurrence	withdraw, complete, lost to follow-up, discontinue treatment
ProtocolDeviationOccurrence	Entity	observed occurrence	submit for classification against applicable rule
ProtocolDeviationDecision	Decision	occurrence + assessment	confirm, reject, classify importance and reportability

Clinical data and review

Object	Kind	Identity / key	Principal behaviour
DataCollectionDefinition	Entity	study version + design revision	publish CRF/event/form/item definitions
Casebook	Entity	participant + collection version	instantiate planned collection and accept migration
EventInstance	Entity	casebook + event occurrence	start, complete, repeat, mark unscheduled
FormInstance	Entity	event + form occurrence	enter, submit, freeze, lock
ItemInstance	Entity	form + item occurrence	host one current DataPoint revision stream
DataPoint	Entity	item occurrence	record, correct, verify, freeze, lock
DataQuery	Entity	query identity against data/collection scope	open, answer, reopen, close, cancel
ReviewRequirement	Definition	review type + data scope	state required SDV/DMR/medical review
ReviewDecision	Decision	reviewer + object revision + review type	accept, reject, revoke when data changes
Signature	Decision/evidence	signer + signed scope + revision	attest meaning against an immutable revision
FreezeDecision	Decision	defined data scope + revision set	prevent ordinary change while permitting governed unfreeze
LockDecision	Decision	defined data scope + revision set	establish finalized state; unlock only by exceptional decision

Monitoring, evidence, safety, supply and finance

Object	Owner	Principal behaviour
MonitoringPlan	Monitoring	define visit strategy, coverage and required activities
MonitoringVisit	Monitoring	plan, confirm, conduct, report and complete
MonitoringActivity	Monitoring	record planned coverage and result
MonitoringFinding	Monitoring	classify observation, assign action and verify resolution
FollowUpAction	Monitoring	assign, due, complete, verify, reopen
TripReport	Monitoring evidence	draft, review, approve and issue as visit evidence
TMFPlan	Essential Records	select taxonomy version, scope, roles and timeliness rules
ArtifactDefinition	Essential Records	classify expected record purpose and recommended filing scope
ExpectedArtifact	Essential Records	declare applicability and expected timing for a study scope
EssentialRecord	Essential Records	receive, classify, quality review, finalize, supersede
DocumentVersion	Content evidence	issue immutable rendition/content version
Filing	Essential Records	connect record to artifact and study/country/site scope
AdverseEvent	Safety	record occurrence and follow clinical course
SafetyAssessment	Safety	decide seriousness, severity, causality and expectedness separately
SafetyCase	Safety	consolidate reportable information and submissions
SupplyPlan	Randomization & Supply	calculate demand by country/site and resupply policy
Kit	Randomization & Supply	release, ship, receive, dispense, return, quarantine, destroy
Shipment	Randomization & Supply	pack, dispatch, receive and record excursion assessment
Dispensation	Randomization & Supply	issue a kit against participant/visit/treatment assignment
SiteAgreement	Site Payments	govern effective budget and payment terms
PayableItem	Site Payments	determine earned, held, approved or reversed
Invoice	Site Payments	submit, reconcile, approve or dispute claimed items
Payment	Site Payments	authorize, issue, fail, void or reconcile
Risk	Quality & Risk	assess probability, impact, detectability and controls
Issue	Quality & Risk	triage, investigate, contain, resolve and verify
CAPA	Quality & Risk	approve actions, implement and verify effectiveness

Deliberate non-objects

The following are not canonical domain entities: dashboard, inbox, task list, table row, API resource, database record, uploaded file, notification, integration job, and “global status.” They may represent or operate on domain objects, but they do not own clinical meaning.