{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.wm-act-054","code":"wm-act-054-research-subject-participant","url":"https://ver.cy/models/wm-act-054-research-subject-participant/","name":"Research Subject / Participant","alternateNames":[],"kind":"world-model","status":"published","version":"0.3.0-research.1","language":"en","classifiers":{"family":"World Models","category":"Activities and processes","entryKind":"aggregate","plane":"","domain":["ACT.RES"],"industry":["Cross-industry"],"navPath":"NAV.ACT.RES","tags":["research","subject","participant","act.res"],"facets":{}},"whatItIs":"Owns one study-specific participation identity; subject and study bindings; subject profile and scoped identifiers; recruitment, screening, eligibility, consent, assent and representative-permission context; enrolment, allocation, blinding and planned path; actual activities, exposure, adherence, safety links, state, withdrawal, outcome, protected data use, corrections and projections. Person, animal, organization, specimen, device, study, protocol, consent artifact, criterion, intervention, observation, adverse event, payment, identity-linkage, ethics, provenance, audit and records masters remain external.","purpose":"Represent one governed subject-to-study participation so agents can reconstruct who or what participated, under which profile, permission, assignment, activities, protections and outcome without absorbing external subject, study or evidence masters.","scope":{"in":["Participation identity, subject profile, protected identifiers, study and protocol bindings, recruitment, screening, eligibility, permission, enrolment and allocation","Planned and actual participation, adherence, safety and compensation links, state, withdrawal, follow-up, data and specimen use, privacy, retention, correction and projections"],"out":["Creating or changing external subject, study, protocol, consent artifact, criterion, intervention, observation, adverse event, payment, identity linkage, ethics, provenance, audit or records masters","Equating screening with eligibility, consent with enrolment, assignment with exposure, completion with benefit, or pseudonymization with anonymity","Autonomous recruitment, eligibility, consent, enrolment, allocation, intervention, unblinding, re-identification, safety decision, compensation, disclosure or deletion"],"boundaries":[{"neighbor":"WM-ACT-036 Research Study","distinction":"The candidate incoming CONTAINS relation may bind participation membership to a parent study. This aggregate cannot own, edit or cascade-delete study protocol, governance or results."},{"neighbor":"Person, animal, organization, specimen, device and product subject models","distinction":"External masters own the subject and its general lifecycle. This aggregate owns only the study-specific participation profile, identifiers and typed reference."},{"neighbor":"Consent, assent and representative-permission artifacts","distinction":"External repositories own source artifacts and legal or ethical validity. Participation stores versioned bindings, process, scope, actors, verification, state and times."},{"neighbor":"Intervention, observation, adverse event, medical-care and payment models","distinction":"External masters own clinical, behavioral, safety, care and financial records. Participation stores typed planned or actual links and bounded interpretations."},{"neighbor":"Identity linkage, privacy and records systems","distinction":"Protected systems own direct identifiers, linkage keys, re-identification controls and physical disposition. Participation stores purpose-bound pseudonymous references, access markings, holds and auditable decisions."},{"neighbor":"FHIR, CDISC, WHO and ClinicalTrials.gov","distinction":"These are versioned healthcare, clinical-data and public study-level projections with different scopes and maturity. No mapping is universally applicable or assumed lossless."}]},"distinguishingFeatures":["Represents one subject's participation in one study, not the person, animal or specimen as such.","Keeps recruitment, eligibility, consent, enrolment, allocation, exposure and withdrawal as separate dated assertions.","Differs from the Research Study model, which defines protocol and arms for all participants.","Uses study-scoped identifiers so that participation records do not become a general identity register."],"structure":{"bundles":[{"id":"participation-identity-subject-profile-and-study-binding","name":"Participation identity, subject profile and study binding","description":"Groups governed participation context for participation identity, subject profile and study binding.","layers":[{"id":"participation-root-and-study-protocol-binding","name":"Participation root and study or protocol binding","description":"Groups source-qualified participation context for participation root and study or protocol binding.","findings":[{"id":"participation-root-identity-namespace-owner-and-current-head","name":"Participation root identity, namespace, owner and current head","description":"Records participation root identity, namespace, owner and current head as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish participation root identity, namespace, owner and current head?","id":"participation-root-identity-namespace-owner-and-current-head-q01","kind":"identity"},{"text":"Who may assert, review, correct or rely on participation root identity, namespace, owner and current head, under which authority, purpose and limits?","id":"participation-root-identity-namespace-owner-and-current-head-q02","kind":"temporal"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to participation root identity, namespace, owner and current head, and which evidence supports them?","id":"participation-root-identity-namespace-owner-and-current-head-q03","kind":"validation"}]},{"id":"study-protocol-site-cohort-and-jurisdiction-binding","name":"Study, protocol, site, cohort and jurisdiction binding","description":"Records study, protocol, site, cohort and jurisdiction binding as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish study, protocol, site, cohort and jurisdiction binding?","id":"study-protocol-site-cohort-and-jurisdiction-binding-q01","kind":"relationship"},{"text":"Who may assert, review, correct or rely on study, protocol, site, cohort and jurisdiction binding, under which authority, purpose and limits?","id":"study-protocol-site-cohort-and-jurisdiction-binding-q02","kind":"composition"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to study, protocol, site, cohort and jurisdiction binding, and which evidence supports them?","id":"study-protocol-site-cohort-and-jurisdiction-binding-q03","kind":"privacy"}]}]},{"id":"subject-kind-profile-and-protected-identity","name":"Subject kind, profile and protected identity","description":"Groups source-qualified participation context for subject kind, profile and protected identity.","findings":[{"id":"subject-kind-unit-of-analysis-species-and-population-profile","name":"Subject kind, unit of analysis, species and population profile","description":"Records subject kind, unit of analysis, species and population profile as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish subject kind, unit of analysis, species and population profile?","id":"subject-kind-unit-of-analysis-species-and-population-profile-q01","kind":"classification"},{"text":"Who may assert, review, correct or rely on subject kind, unit of analysis, species and population profile, under which authority, purpose and limits?","id":"subject-kind-unit-of-analysis-species-and-population-profile-q02","kind":"evidence"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to subject kind, unit of analysis, species and population profile, and which evidence supports them?","id":"subject-kind-unit-of-analysis-species-and-population-profile-q03","kind":"lifecycle"}]},{"id":"external-subject-master-study-identifiers-pseudonym-and-link-key","name":"External subject master, study identifiers, pseudonym and link key","description":"Records external subject master, study identifiers, pseudonym and link key as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish external subject master, study identifiers, pseudonym and link key?","id":"external-subject-master-study-identifiers-pseudonym-and-link-key-q01","kind":"security"},{"text":"Who may assert, review, correct or rely on external subject master, study identifiers, pseudonym and link key, under which authority, purpose and limits?","id":"external-subject-master-study-identifiers-pseudonym-and-link-key-q02","kind":"ownership"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to external subject master, study identifiers, pseudonym and link key, and which evidence supports them?","id":"external-subject-master-study-identifiers-pseudonym-and-link-key-q03","kind":"quality"}]}]}]},{"id":"recruitment-screening-eligibility-and-consent","name":"Recruitment, screening, eligibility and consent","description":"Groups governed participation context for recruitment, screening, eligibility and consent.","layers":[{"id":"recruitment-prescreening-and-screening","name":"Recruitment, prescreening and screening","description":"Groups source-qualified participation context for recruitment, prescreening and screening.","findings":[{"id":"recruitment-source-contact-permission-prescreening-and-candidate-state","name":"Recruitment source, contact permission, prescreening and candidate state","description":"Records recruitment source, contact permission, prescreening and candidate state as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish recruitment source, contact permission, prescreening and candidate state?","id":"recruitment-source-contact-permission-prescreening-and-candidate-state-q01","kind":"process"},{"text":"Who may assert, review, correct or rely on recruitment source, contact permission, prescreening and candidate state, under which authority, purpose and limits?","id":"recruitment-source-contact-permission-prescreening-and-candidate-state-q02","kind":"measurement"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to recruitment source, contact permission, prescreening and candidate state, and which evidence supports them?","id":"recruitment-source-contact-permission-prescreening-and-candidate-state-q03","kind":"security"}]},{"id":"screening-event-procedure-result-status-failure-and-rescreening","name":"Screening event, procedure, result, status, failure and rescreening","description":"Records screening event, procedure, result, status, failure and rescreening as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish screening event, procedure, result, status, failure and rescreening?","id":"screening-event-procedure-result-status-failure-and-rescreening-q01","kind":"event"},{"text":"Who may assert, review, correct or rely on screening event, procedure, result, status, failure and rescreening, under which authority, purpose and limits?","id":"screening-event-procedure-result-status-failure-and-rescreening-q02","kind":"exception"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to screening event, procedure, result, status, failure and rescreening, and which evidence supports them?","id":"screening-event-procedure-result-status-failure-and-rescreening-q03","kind":"retention"}]}]},{"id":"eligibility-and-permission","name":"Eligibility and permission","description":"Groups source-qualified participation context for eligibility and permission.","findings":[{"id":"criterion-evaluation-eligibility-decision-waiver-authority-and-evidence","name":"Criterion evaluation, eligibility decision, waiver authority and evidence","description":"Records criterion evaluation, eligibility decision, waiver authority and evidence as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish criterion evaluation, eligibility decision, waiver authority and evidence?","id":"criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q01","kind":"decision"},{"text":"Who may assert, review, correct or rely on criterion evaluation, eligibility decision, waiver authority and evidence, under which authority, purpose and limits?","id":"criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q02","kind":"provenance"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to criterion evaluation, eligibility decision, waiver authority and evidence, and which evidence supports them?","id":"criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q03","kind":"interoperability"}]},{"id":"consent-assent-representative-permission-reconsent-refusal-and-source","name":"Consent, assent, representative permission, reconsent, refusal and source","description":"Records consent, assent, representative permission, reconsent, refusal and source as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish consent, assent, representative permission, reconsent, refusal and source?","id":"consent-assent-representative-permission-reconsent-refusal-and-source-q01","kind":"authority"},{"text":"Who may assert, review, correct or rely on consent, assent, representative permission, reconsent, refusal and source, under which authority, purpose and limits?","id":"consent-assent-representative-permission-reconsent-refusal-and-source-q02","kind":"process"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to consent, assent, representative permission, reconsent, refusal and source, and which evidence supports them?","id":"consent-assent-representative-permission-reconsent-refusal-and-source-q03","kind":"decision"}]}]}]},{"id":"enrolment-allocation-blinding-and-participation-plan","name":"Enrolment, allocation, blinding and participation plan","description":"Groups governed participation context for enrolment, allocation, blinding and participation plan.","layers":[{"id":"enrolment-randomization-allocation-and-blinding","name":"Enrolment, randomization, allocation and blinding","description":"Groups source-qualified participation context for enrolment, randomization, allocation and blinding.","findings":[{"id":"enrolment-event-identifier-site-date-authority-and-prerequisites","name":"Enrolment event, identifier, site, date, authority and prerequisites","description":"Records enrolment event, identifier, site, date, authority and prerequisites as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish enrolment event, identifier, site, date, authority and prerequisites?","id":"enrolment-event-identifier-site-date-authority-and-prerequisites-q01","kind":"lifecycle"},{"text":"Who may assert, review, correct or rely on enrolment event, identifier, site, date, authority and prerequisites, under which authority, purpose and limits?","id":"enrolment-event-identifier-site-date-authority-and-prerequisites-q02","kind":"validation"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to enrolment event, identifier, site, date, authority and prerequisites, and which evidence supports them?","id":"enrolment-event-identifier-site-date-authority-and-prerequisites-q03","kind":"state"}]},{"id":"randomization-stratum-allocation-concealment-assigned-arm-and-blinding","name":"Randomization, stratum, allocation concealment, assigned arm and blinding","description":"Records randomization, stratum, allocation concealment, assigned arm and blinding as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish randomization, stratum, allocation concealment, assigned arm and blinding?","id":"randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q01","kind":"security"},{"text":"Who may assert, review, correct or rely on randomization, stratum, allocation concealment, assigned arm and blinding, under which authority, purpose and limits?","id":"randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q02","kind":"privacy"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to randomization, stratum, allocation concealment, assigned arm and blinding, and which evidence supports them?","id":"randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q03","kind":"identity"}]}]},{"id":"planned-path-periods-visits-and-activities","name":"Planned path, periods, visits and activities","description":"Groups source-qualified participation context for planned path, periods, visits and activities.","findings":[{"id":"planned-arm-cohort-comparison-group-and-participation-period","name":"Planned arm, cohort, comparison group and participation period","description":"Records planned arm, cohort, comparison group and participation period as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned arm, cohort, comparison group and participation period?","id":"planned-arm-cohort-comparison-group-and-participation-period-q01","kind":"composition"},{"text":"Who may assert, review, correct or rely on planned arm, cohort, comparison group and participation period, under which authority, purpose and limits?","id":"planned-arm-cohort-comparison-group-and-participation-period-q02","kind":"lifecycle"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to planned arm, cohort, comparison group and participation period, and which evidence supports them?","id":"planned-arm-cohort-comparison-group-and-participation-period-q03","kind":"classification"}]},{"id":"planned-visit-activity-intervention-observation-and-window","name":"Planned visit, activity, intervention, observation and window","description":"Records planned visit, activity, intervention, observation and window as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned visit, activity, intervention, observation and window?","id":"planned-visit-activity-intervention-observation-and-window-q01","kind":"requirement"},{"text":"Who may assert, review, correct or rely on planned visit, activity, intervention, observation and window, under which authority, purpose and limits?","id":"planned-visit-activity-intervention-observation-and-window-q02","kind":"quality"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to planned visit, activity, intervention, observation and window, and which evidence supports them?","id":"planned-visit-activity-intervention-observation-and-window-q03","kind":"relationship"}]}]}]},{"id":"actual-participation-safety-adherence-and-compensation","name":"Actual participation, safety, adherence and compensation","description":"Groups governed participation context for actual participation, safety, adherence and compensation.","layers":[{"id":"actual-activities-exposure-adherence-and-deviation","name":"Actual activities, exposure, adherence and deviation","description":"Groups source-qualified participation context for actual activities, exposure, adherence and deviation.","findings":[{"id":"actual-visit-activity-intervention-exposure-dose-and-observation-reference","name":"Actual visit, activity, intervention, exposure, dose and observation reference","description":"Records actual visit, activity, intervention, exposure, dose and observation reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish actual visit, activity, intervention, exposure, dose and observation reference?","id":"actual-visit-activity-intervention-exposure-dose-and-observation-reference-q01","kind":"evidence"},{"text":"Who may assert, review, correct or rely on actual visit, activity, intervention, exposure, dose and observation reference, under which authority, purpose and limits?","id":"actual-visit-activity-intervention-exposure-dose-and-observation-reference-q02","kind":"security"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to actual visit, activity, intervention, exposure, dose and observation reference, and which evidence supports them?","id":"actual-visit-activity-intervention-exposure-dose-and-observation-reference-q03","kind":"authority"}]},{"id":"attendance-adherence-nonadherence-protocol-deviation-and-impact","name":"Attendance, adherence, nonadherence, protocol deviation and impact","description":"Records attendance, adherence, nonadherence, protocol deviation and impact as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish attendance, adherence, nonadherence, protocol deviation and impact?","id":"attendance-adherence-nonadherence-protocol-deviation-and-impact-q01","kind":"quality"},{"text":"Who may assert, review, correct or rely on attendance, adherence, nonadherence, protocol deviation and impact, under which authority, purpose and limits?","id":"attendance-adherence-nonadherence-protocol-deviation-and-impact-q02","kind":"retention"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to attendance, adherence, nonadherence, protocol deviation and impact, and which evidence supports them?","id":"attendance-adherence-nonadherence-protocol-deviation-and-impact-q03","kind":"requirement"}]}]},{"id":"safety-incidents-medical-care-and-compensation","name":"Safety, incidents, medical care and compensation","description":"Groups source-qualified participation context for safety, incidents, medical care and compensation.","findings":[{"id":"safety-observation-adverse-event-seriousness-causality-and-report-reference","name":"Safety observation, adverse event, seriousness, causality and report reference","description":"Records safety observation, adverse event, seriousness, causality and report reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish safety observation, adverse event, seriousness, causality and report reference?","id":"safety-observation-adverse-event-seriousness-causality-and-report-reference-q01","kind":"evidence"},{"text":"Who may assert, review, correct or rely on safety observation, adverse event, seriousness, causality and report reference, under which authority, purpose and limits?","id":"safety-observation-adverse-event-seriousness-causality-and-report-reference-q02","kind":"interoperability"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to safety observation, adverse event, seriousness, causality and report reference, and which evidence supports them?","id":"safety-observation-adverse-event-seriousness-causality-and-report-reference-q03","kind":"constraint"}]},{"id":"research-injury-medical-care-compensation-reimbursement-and-payment-reference","name":"Research injury, medical care, compensation, reimbursement and payment reference","description":"Records research injury, medical care, compensation, reimbursement and payment reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish research injury, medical care, compensation, reimbursement and payment reference?","id":"research-injury-medical-care-compensation-reimbursement-and-payment-reference-q01","kind":"relationship"},{"text":"Who may assert, review, correct or rely on research injury, medical care, compensation, reimbursement and payment reference, under which authority, purpose and limits?","id":"research-injury-medical-care-compensation-reimbursement-and-payment-reference-q02","kind":"decision"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to research injury, medical care, compensation, reimbursement and payment reference, and which evidence supports them?","id":"research-injury-medical-care-compensation-reimbursement-and-payment-reference-q03","kind":"event"}]}]}]},{"id":"status-outcome-withdrawal-followup-and-data-use","name":"Status, outcome, withdrawal, follow-up and data use","description":"Groups governed participation context for status, outcome, withdrawal, follow-up and data use.","layers":[{"id":"states-milestones-holds-and-study-effects","name":"States, milestones, holds and study effects","description":"Groups source-qualified participation context for states, milestones, holds and study effects.","findings":[{"id":"candidate-screened-eligible-consented-enrolled-active-and-followup-state","name":"Candidate, screened, eligible, consented, enrolled, active and follow-up state","description":"Records candidate, screened, eligible, consented, enrolled, active and follow-up state as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish candidate, screened, eligible, consented, enrolled, active and follow-up state?","id":"candidate-screened-eligible-consented-enrolled-active-and-followup-state-q01","kind":"state"},{"text":"Who may assert, review, correct or rely on candidate, screened, eligible, consented, enrolled, active and follow-up state, under which authority, purpose and limits?","id":"candidate-screened-eligible-consented-enrolled-active-and-followup-state-q02","kind":"state"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to candidate, screened, eligible, consented, enrolled, active and follow-up state, and which evidence supports them?","id":"candidate-screened-eligible-consented-enrolled-active-and-followup-state-q03","kind":"temporal"}]},{"id":"milestone-hold-suspension-site-closure-study-termination-and-subject-effect","name":"Milestone, hold, suspension, site closure, study termination and subject effect","description":"Records milestone, hold, suspension, site closure, study termination and subject effect as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish milestone, hold, suspension, site closure, study termination and subject effect?","id":"milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q01","kind":"event"},{"text":"Who may assert, review, correct or rely on milestone, hold, suspension, site closure, study termination and subject effect, under which authority, purpose and limits?","id":"milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q02","kind":"identity"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to milestone, hold, suspension, site closure, study termination and subject effect, and which evidence supports them?","id":"milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q03","kind":"composition"}]}]},{"id":"withdrawal-discontinuation-loss-completion-and-disposition","name":"Withdrawal, discontinuation, loss, completion and disposition","description":"Groups source-qualified participation context for withdrawal, discontinuation, loss, completion and disposition.","findings":[{"id":"refusal-withdrawal-scope-intervention-discontinuation-and-reason","name":"Refusal, withdrawal scope, intervention discontinuation and reason","description":"Records refusal, withdrawal scope, intervention discontinuation and reason as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish refusal, withdrawal scope, intervention discontinuation and reason?","id":"refusal-withdrawal-scope-intervention-discontinuation-and-reason-q01","kind":"lifecycle"},{"text":"Who may assert, review, correct or rely on refusal, withdrawal scope, intervention discontinuation and reason, under which authority, purpose and limits?","id":"refusal-withdrawal-scope-intervention-discontinuation-and-reason-q02","kind":"classification"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to refusal, withdrawal scope, intervention discontinuation and reason, and which evidence supports them?","id":"refusal-withdrawal-scope-intervention-discontinuation-and-reason-q03","kind":"evidence"}]},{"id":"lost-to-followup-completion-off-study-death-reference-and-outcome","name":"Lost to follow-up, completion, off-study, death reference and outcome","description":"Records lost to follow-up, completion, off-study, death reference and outcome as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish lost to follow-up, completion, off-study, death reference and outcome?","id":"lost-to-followup-completion-off-study-death-reference-and-outcome-q01","kind":"state"},{"text":"Who may assert, review, correct or rely on lost to follow-up, completion, off-study, death reference and outcome, under which authority, purpose and limits?","id":"lost-to-followup-completion-off-study-death-reference-and-outcome-q02","kind":"relationship"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to lost to follow-up, completion, off-study, death reference and outcome, and which evidence supports them?","id":"lost-to-followup-completion-off-study-death-reference-and-outcome-q03","kind":"ownership"}]}]}]},{"id":"privacy-deidentification-correction-retention-and-interoperability","name":"Privacy, de-identification, correction, retention and interoperability","description":"Groups governed participation context for privacy, de-identification, correction, retention and interoperability.","layers":[{"id":"data-specimen-use-privacy-and-linkage","name":"Data or specimen use, privacy and linkage","description":"Groups source-qualified participation context for data or specimen use, privacy and linkage.","findings":[{"id":"data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope","name":"Data, specimen, future contact, secondary use, withdrawal and retention scope","description":"Records data, specimen, future contact, secondary use, withdrawal and retention scope as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish data, specimen, future contact, secondary use, withdrawal and retention scope?","id":"data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q01","kind":"privacy"},{"text":"Who may assert, review, correct or rely on data, specimen, future contact, secondary use, withdrawal and retention scope, under which authority, purpose and limits?","id":"data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q02","kind":"authority"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to data, specimen, future contact, secondary use, withdrawal and retention scope, and which evidence supports them?","id":"data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q03","kind":"measurement"}]},{"id":"pseudonymization-deidentification-linkage-reidentification-risk-and-authority","name":"Pseudonymization, de-identification, linkage, re-identification risk and authority","description":"Records pseudonymization, de-identification, linkage, re-identification risk and authority as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish pseudonymization, de-identification, linkage, re-identification risk and authority?","id":"pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q01","kind":"security"},{"text":"Who may assert, review, correct or rely on pseudonymization, de-identification, linkage, re-identification risk and authority, under which authority, purpose and limits?","id":"pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q02","kind":"requirement"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to pseudonymization, de-identification, linkage, re-identification risk and authority, and which evidence supports them?","id":"pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q03","kind":"exception"}]}]},{"id":"access-correction-retention-and-projections","name":"Access, correction, retention and projections","description":"Groups source-qualified participation context for access, correction, retention and projections.","findings":[{"id":"role-purpose-access-disclosure-audit-correction-hold-and-disposition","name":"Role, purpose, access, disclosure, audit, correction, hold and disposition","description":"Records role, purpose, access, disclosure, audit, correction, hold and disposition as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish role, purpose, access, disclosure, audit, correction, hold and disposition?","id":"role-purpose-access-disclosure-audit-correction-hold-and-disposition-q01","kind":"access"},{"text":"Who may assert, review, correct or rely on role, purpose, access, disclosure, audit, correction, hold and disposition, under which authority, purpose and limits?","id":"role-purpose-access-disclosure-audit-correction-hold-and-disposition-q02","kind":"constraint"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to role, purpose, access, disclosure, audit, correction, hold and disposition, and which evidence supports them?","id":"role-purpose-access-disclosure-audit-correction-hold-and-disposition-q03","kind":"provenance"}]},{"id":"fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss","name":"FHIR, CDISC, WHO, ClinicalTrials registry projection, version and loss","description":"Records fhir, cdisc, who, clinicaltrials registry projection, version and loss as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.","questions":[{"text":"What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish fhir, cdisc, who, clinicaltrials registry projection, version and loss?","id":"fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q01","kind":"interoperability"},{"text":"Who may assert, review, correct or rely on fhir, cdisc, who, clinicaltrials registry projection, version and loss, under which authority, purpose and limits?","id":"fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q02","kind":"event"},{"text":"Which event, effective, recorded, ingested and knowledge times apply to fhir, cdisc, who, clinicaltrials registry projection, version and loss, and which evidence supports them?","id":"fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q03","kind":"process"}]}]}]}]},"agentConduct":{"may":["Record screening and recruitment events from authorized staff.","Track visit schedules, completed activities and follow-up windows.","Flag missing consent versions or expired permissions for review.","Produce pseudonymized projections for permitted analysis."],"mustNot":["Recruit or contact potential participants without approval.","Decide eligibility, obtain consent, enroll or allocate a subject.","Unblind an allocation or re-identify a pseudonymized subject.","Make safety decisions or report adverse events as final.","Continue processing a subject's data after withdrawal beyond what the consent allows."],"requiresHuman":["Eligibility decisions and enrolment.","Unblinding for safety reasons.","Handling withdrawal of consent and its effect on retained data."]},"ethics":{"considerations":["Participants carry the risks of research, so consent, withdrawal and safety records must be exact and current.","Vulnerable groups such as children, patients lacking capacity and animals need extra protection.","Pseudonymized research data can often be re-identified, so release needs controls."],"affectedParties":["Research participants and their representatives","Investigators and ethics committees","Animals used in research"]},"owners":{"steward":"Dimension owner and research-processing mandate","roles":[{"name":"Research participant or authorized representative","responsibilities":["Exercise applicable information, permission, refusal, withdrawal and rights processes without being treated as the data owner by default."]},{"name":"Principal investigator and site investigator","responsibilities":["Own qualified subject protection, clinical oversight, protocol conduct and source-qualified decisions within delegation."]},{"name":"Sponsor and research owner","responsibilities":["Own study purpose, quality system, oversight, risk management and accountable trial responsibilities."]},{"name":"IRB or independent ethics committee","responsibilities":["Provide independent ethical review and continuing oversight according to applicable rules."]},{"name":"Research coordinator and delegated staff","responsibilities":["Perform documented recruitment, screening, consent support, visits and data capture within delegated scope."]},{"name":"Safety and medical monitor","responsibilities":["Review safety evidence and perform authorized reporting and medical escalation without autonomous agent substitution."]},{"name":"Privacy, data and records steward","responsibilities":["Own protected views, linkage controls, data use, disclosures, corrections, holds, retention and auditability."]}],"masterSystems":[]},"relations":[{"target":"WM-ACT-036 Research Study","type":"references","note":"Bind candidate parent study membership without owning study governance, protocol or results."},{"target":"Person, animal, organization, specimen, device or product subject model","type":"references","note":"Resolve who or what participates while preserving the external subject lifecycle."},{"target":"Protocol, ethics, consent, criterion, intervention, observation, adverse-event, care, payment, identity-linkage, provenance, audit and records models","type":"references","note":"Resolve authoritative research and evidence records without absorbing their ownership or lifecycle."},{"target":"FHIR R5, CDISC ODM 2.0, CDASHIG 2.2, WHO TRDS 1.3.1 and ClinicalTrials.gov","type":"aligned","note":"Project version-pinned clinical and registry views with maturity, scope and information-loss declarations."},{"target":"WM-ACT-036 Research Study","type":"neighbor","note":"The candidate incoming CONTAINS relation may bind participation membership to a parent study. This aggregate cannot own, edit or cascade-delete study protocol, governance or results."},{"target":"Person, animal, organization, specimen, device and product subject models","type":"neighbor","note":"External masters own the subject and its general lifecycle. This aggregate owns only the study-specific participation profile, identifiers and typed reference."},{"target":"Consent, assent and representative-permission artifacts","type":"neighbor","note":"External repositories own source artifacts and legal or ethical validity. Participation stores versioned bindings, process, scope, actors, verification, state and times."},{"target":"Intervention, observation, adverse event, medical-care and payment models","type":"neighbor","note":"External masters own clinical, behavioral, safety, care and financial records. Participation stores typed planned or actual links and bounded interpretations."},{"target":"Identity linkage, privacy and records systems","type":"neighbor","note":"Protected systems own direct identifiers, linkage keys, re-identification controls and physical disposition. Participation stores purpose-bound pseudonymous references, access markings, holds and auditable decisions."},{"target":"FHIR, CDISC, WHO and ClinicalTrials.gov","type":"neighbor","note":"These are versioned healthcare, clinical-data and public study-level projections with different scopes and maturity. No mapping is universally applicable or assumed lossless."},{"target":"WM-ACT-036","type":"parent"}],"interaction":{"identity":{"applicability":"required","items":["Authoritative master-system identifier for each participation, assertion, decision, permission or event, qualified by issuer, namespace and record kind.","Governed globally resolvable research-participation IRI.","Dimension UUID or ULID when neither preceding identifier exists."]},"properties":{"applicability":"not-applicable","items":[]},"recognition":{"applicability":"optional","items":["A participation record names a study, a subject reference, a study-specific subject ID, a consent state and an enrolment or arm state.","Often confused with the patient record, the study itself, a specimen record or a consent document."]},"capabilities":{"applicability":"required","items":["Register research participation: Governed operation to register research participation without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Bind identifiers and subject profile: Governed operation to bind identifiers and subject profile without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Record recruitment and screening: Governed operation to record recruitment and screening without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Record eligibility decision: Governed operation to record eligibility decision without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Bind consent, assent and permission: Governed operation to bind consent, assent and permission without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Record enrolment, allocation and blinding: Governed operation to record enrolment, allocation and blinding without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Record participation activities: Governed operation to record participation activities without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Record safety and compensation links: Governed operation to record safety and compensation links without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Withdraw, discontinue, follow up or close: Governed operation to withdraw, discontinue, follow up or close without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.","Correct, project, retain, disclose and audit: Governed operation to correct, project, retain, disclose and audit without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion."]},"hazards":{"applicability":"required","items":["Enrolment without valid consent.","Accidental unblinding.","Re-identification of participants from released data.","Lost follow-up of a subject with a safety event."]},"interfaces":{"applicability":"required","items":["HL7 FHIR R5 ResearchSubject, ResearchStudy and Consent resources.","CDISC SDTM and CDISC ODM.","ICH E6 Good Clinical Practice.","WHO International Clinical Trials Registry Platform and ClinicalTrials.gov registration identifiers."]},"context":{"applicability":"required","items":["Research authorization, consent, representative authority, privacy, safety reporting, compensation, retention and subject rights depend on jurisdiction, research type, institution and protocol.","45 CFR 46 and HIPAA are United States profiles; Regulation 536/2014 and GDPR are European Union profiles; ICH, WMA and ISO adoption still requires local validation.","FHIR R5 ResearchSubject is Trial Use, and CDISC, WHO and ClinicalTrials.gov mappings require release-pinned profiles and scope limits."]}},"sources":[{"title":"ICH E6(R3) Guideline for Good Clinical Practice","url":"https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106_ErrorCorrections_2025_1024.pdf","note":"International Council for Harmonisation"},{"title":"ICH E8(R1) General Considerations for Clinical Studies","url":"https://database.ich.org/sites/default/files/ICH_E8-R1_Guideline_Step4_2021_1006.pdf","note":"International Council for Harmonisation"},{"title":"WMA Declaration of Helsinki","url":"https://www.wma.net/policies-post/wma-declaration-of-helsinki/","note":"World Medical Association"},{"title":"45 CFR Part 46 Protection of Human Subjects","url":"https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46","note":"United States Office of the Federal Register"},{"title":"The Belmont Report","url":"https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html","note":"United States Department of Health and Human Services"},{"title":"Regulation (EU) No 536/2014 on clinical trials","url":"https://eur-lex.europa.eu/eli/reg/2014/536/oj","note":"European Union"},{"title":"WHO Trial Registration Data Set","url":"https://www.who.int/tools/clinical-trials-registry-platform/network/who-data-set","note":"World Health Organization"},{"title":"FHIR R5 ResearchSubject","url":"https://hl7.org/fhir/R5/researchsubject.html","note":"HL7 International"},{"title":"FHIR R5 ResearchStudy","url":"https://hl7.org/fhir/R5/researchstudy.html","note":"HL7 International"},{"title":"FHIR R5 Consent","url":"https://hl7.org/fhir/R5/consent.html","note":"HL7 International"},{"title":"Operational Data Model","url":"https://www.cdisc.org/standards/data-exchange/odm-xml/odm-v2-0","note":"Clinical Data Interchange Standards Consortium"},{"title":"CDASH Implementation Guide","url":"https://www.cdisc.org/standards/foundational/cdash/cdashig-v2-2","note":"Clinical Data Interchange Standards Consortium"},{"title":"ISO 14155 Clinical investigation of medical devices for human subjects","url":"https://www.iso.org/standard/14155","note":"International Organization for Standardization"},{"title":"HIPAA de-identification guidance","url":"https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html","note":"United States Department of Health and Human Services"},{"title":"PROV-O: The PROV Ontology","url":"https://www.w3.org/TR/prov-o/","note":"World Wide Web Consortium"},{"title":"Regulation (EU) 2016/679 General Data Protection Regulation","url":"https://eur-lex.europa.eu/eli/reg/2016/679/oj","note":"European Union"},{"title":"Date and Time on the Internet: Timestamps","url":"https://www.rfc-editor.org/info/rfc3339/","note":"Internet Engineering Task Force"},{"title":"ClinicalTrials.gov Study Data Structure","url":"https://clinicaltrials.gov/data-api/about-api/study-data-structure","note":"United States National Library of Medicine"}],"openQuestions":["Approve or reject candidate containment by WM-ACT-036 and register subject, protocol, consent, intervention, observation, safety, payment, identity-linkage, provenance and records relations.","Create subject and research profiles for human clinical, observational, behavioral, public-health, device, animal, specimen, product, group and other study types.","Validate jurisdiction-specific ethics, consent, representative authority, safety, compensation, privacy, re-identification, retention and subject-rights rules.","Test release-pinned FHIR, CDISC, WHO and ClinicalTrials.gov mappings with conformance, round-trip and information-loss evidence.","Obtain licensed source review where needed and supplemental independent external review before canonical promotion.","Claude and Grok each timed out on one bounded attempt; no independent external result was admitted.","The only relation-ledger edge is candidate incoming WM-ACT-036 CONTAINS WM-ACT-054; it is not approved composition or cascade authority.","Human clinical, observational, behavioral, public-health, device, animal, specimen, product, group and other research require explicit profiles.","The ISO 14155:2026 normative text and detailed CDISC files are access-restricted; only official public metadata was used for their bounded claims."],"resources":{"spec":"/models/wm-act-054-research-subject-participant/spec.yaml","agents":"/models/wm-act-054-research-subject-participant/AGENTS.md","source":"https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/publications/wm-act-054-research-subject-participant"},"provenance":{"origin":"world-models research","builtFrom":["models/wm-act-054-research-subject-participant/spec.yaml","ver-cy/world-models/card-supplements/wm-act-054-research-subject-participant.json"],"providers":["Codex"],"researchStatus":"reviewable-draft","generatedAt":"2026-09-06T11:13:55Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"not-applicable","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"interaction.properties":"Institutional or informational subject: no invented physical properties.","_supplement":"Sections authored in card supplement 1.0.0 by Claude (Opus 5.5) (2026-10-05, unreviewed). Written from the published specification and established practice in the field; no new sources were read. Unreviewed."},"score":1.0}}