Study Participant

Category: Entity
Review status: Proposed

Meaning

A StudyParticipant represents one person’s purpose-limited participation in one Study. It is not a universal patient identity and does not expose the person’s identity to every domain.

Related objects

Object	Meaning
Candidate	Recruitment-stage identity before site handoff
ScreeningEpisode	One attempt to determine eligibility
ConsentDecision	Permission granted, declined, or withdrawn for declared purposes
EligibilityDecision	Authorized conclusion against a Protocol Version
Enrollment	Formal entry into the Study
ProtocolAssignment	Exact Protocol Version governing conduct
TreatmentAssignment	Randomized or assigned treatment strategy
ParticipantSchedule	Expected activities derived for this participant
ParticipantOutcome	Completion, withdrawal, death, or other terminal outcome

Fields

Field	Type	Meaning
identity	StudyParticipantIdentity	Stable, study-scoped identity
study	StudyReference	Study in which the person participates
currentSite	StudySiteReference	Site currently responsible for conduct
identifiers	ParticipantIdentifier[]	Purpose-specific identifiers and history
screeningEpisodes	ScreeningEpisode[]	Screening and rescreening history
consents	ConsentDecision[]	Effective consent history by purpose
enrollment	Enrollment?	Enrollment decision and date
protocolAssignment	ProtocolAssignment?	Governing Protocol Version
status	ParticipantStatus	Current participation state
outcome	ParticipantOutcome?	Study/intervention outcome

Behaviours

participant.startScreening(consent: EffectiveConsent): ScreeningStarted;
participant.recordScreenFailure(decision: IneligibleDecision): ScreeningFailed;
participant.startRescreening(authorization: RescreenAuthorization): RescreeningStarted;
participant.enroll(input: EnrollmentAssessment): ParticipantEnrolled;
participant.assignProtocol(version: ApplicableProtocolVersion): ProtocolAssigned;
participant.transferTo(site: OpenStudySite, approval: TransferDecision): ParticipantTransferred;
participant.discontinueIntervention(reason: DiscontinuationReason): InterventionDiscontinued;
participant.withdraw(decision: WithdrawalDecision): ParticipantWithdrawn;
participant.complete(outcome: CompletionAssessment): ParticipantCompletedStudy;

Rules

• Screening requires applicable consent for screening activities.
• Enrollment requires effective consent and a positive eligibility decision.
• Eligibility is determined against one exact Protocol Version.
• Study withdrawal and intervention discontinuation are different outcomes.
• Participant identity remains stable through identifier correction and site transfer.
• Prior lawful observations and evidence survive withdrawal.
• Cross-domain identifiers are linked only for an authorized purpose.

Outcomes

ScreeningStarted, ParticipantFoundIneligible, RescreeningStarted, ParticipantEnrolled, ProtocolAssigned, ParticipantTransferred, InterventionDiscontinued, ParticipantWithdrawn, ParticipantCompletedStudy.

Product questions

• When is rescreening a new episode versus a new participant identity?
• Can a participant have concurrent enrollments under a master protocol?
• Which post-withdrawal data-cleaning and safety activities remain permitted?
• How should participant transfer affect scheduled activities and investigator attestations?