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Research Subject / Participant

vr.wm-act-054 · wm-act-054-research-subject-participant

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.

World Models Activities and processes ACT.RES
Bundle → Layer → Finding → QuestionsClassifiersWhat it isWhy it existsDistinguishing featuresWhat robots and AI may and may not doMoral aspectsOwnersLinks to other meta-modelsIdentity and identifiersDirect propertiesRecognitionCapabilities and actionsHazards and failure modesStandards and interfacesContext of useSources

Bundle → Layer → Finding → Questions Filled

6 bundles · 12 layers · 24 findings · 72 questions

Participation identity, subject profile and study binding Groups governed participation context for participation identity, subject profile and study binding.

Participation root and study or protocol binding

Groups source-qualified participation context for participation root and study or protocol binding.

Participation root identity, namespace, owner and current head

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish participation root identity, namespace, owner and current head? identity
  2. Who may assert, review, correct or rely on participation root identity, namespace, owner and current head, under which authority, purpose and limits? temporal
  3. Which event, effective, recorded, ingested and knowledge times apply to participation root identity, namespace, owner and current head, and which evidence supports them? validation

Study, protocol, site, cohort and jurisdiction binding

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish study, protocol, site, cohort and jurisdiction binding? relationship
  2. Who may assert, review, correct or rely on study, protocol, site, cohort and jurisdiction binding, under which authority, purpose and limits? composition
  3. Which event, effective, recorded, ingested and knowledge times apply to study, protocol, site, cohort and jurisdiction binding, and which evidence supports them? privacy

Subject kind, profile and protected identity

Groups source-qualified participation context for subject kind, profile and protected identity.

Subject kind, unit of analysis, species and population profile

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish subject kind, unit of analysis, species and population profile? classification
  2. Who may assert, review, correct or rely on subject kind, unit of analysis, species and population profile, under which authority, purpose and limits? evidence
  3. Which event, effective, recorded, ingested and knowledge times apply to subject kind, unit of analysis, species and population profile, and which evidence supports them? lifecycle

External subject master, study identifiers, pseudonym and link key

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish external subject master, study identifiers, pseudonym and link key? security
  2. Who may assert, review, correct or rely on external subject master, study identifiers, pseudonym and link key, under which authority, purpose and limits? ownership
  3. Which event, effective, recorded, ingested and knowledge times apply to external subject master, study identifiers, pseudonym and link key, and which evidence supports them? quality
Recruitment, screening, eligibility and consent Groups governed participation context for recruitment, screening, eligibility and consent.

Recruitment, prescreening and screening

Groups source-qualified participation context for recruitment, prescreening and screening.

Recruitment source, contact permission, prescreening and candidate state

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish recruitment source, contact permission, prescreening and candidate state? process
  2. Who may assert, review, correct or rely on recruitment source, contact permission, prescreening and candidate state, under which authority, purpose and limits? measurement
  3. Which event, effective, recorded, ingested and knowledge times apply to recruitment source, contact permission, prescreening and candidate state, and which evidence supports them? security

Screening event, procedure, result, status, failure and rescreening

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish screening event, procedure, result, status, failure and rescreening? event
  2. Who may assert, review, correct or rely on screening event, procedure, result, status, failure and rescreening, under which authority, purpose and limits? exception
  3. Which event, effective, recorded, ingested and knowledge times apply to screening event, procedure, result, status, failure and rescreening, and which evidence supports them? retention

Eligibility and permission

Groups source-qualified participation context for eligibility and permission.

Criterion evaluation, eligibility decision, waiver authority and evidence

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish criterion evaluation, eligibility decision, waiver authority and evidence? decision
  2. Who may assert, review, correct or rely on criterion evaluation, eligibility decision, waiver authority and evidence, under which authority, purpose and limits? provenance
  3. Which event, effective, recorded, ingested and knowledge times apply to criterion evaluation, eligibility decision, waiver authority and evidence, and which evidence supports them? interoperability

Consent, assent, representative permission, reconsent, refusal and source

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish consent, assent, representative permission, reconsent, refusal and source? authority
  2. Who may assert, review, correct or rely on consent, assent, representative permission, reconsent, refusal and source, under which authority, purpose and limits? process
  3. Which event, effective, recorded, ingested and knowledge times apply to consent, assent, representative permission, reconsent, refusal and source, and which evidence supports them? decision
Enrolment, allocation, blinding and participation plan Groups governed participation context for enrolment, allocation, blinding and participation plan.

Enrolment, randomization, allocation and blinding

Groups source-qualified participation context for enrolment, randomization, allocation and blinding.

Enrolment event, identifier, site, date, authority and prerequisites

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish enrolment event, identifier, site, date, authority and prerequisites? lifecycle
  2. Who may assert, review, correct or rely on enrolment event, identifier, site, date, authority and prerequisites, under which authority, purpose and limits? validation
  3. Which event, effective, recorded, ingested and knowledge times apply to enrolment event, identifier, site, date, authority and prerequisites, and which evidence supports them? state

Randomization, stratum, allocation concealment, assigned arm and blinding

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish randomization, stratum, allocation concealment, assigned arm and blinding? security
  2. Who may assert, review, correct or rely on randomization, stratum, allocation concealment, assigned arm and blinding, under which authority, purpose and limits? privacy
  3. Which event, effective, recorded, ingested and knowledge times apply to randomization, stratum, allocation concealment, assigned arm and blinding, and which evidence supports them? identity

Planned path, periods, visits and activities

Groups source-qualified participation context for planned path, periods, visits and activities.

Planned arm, cohort, comparison group and participation period

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned arm, cohort, comparison group and participation period? composition
  2. Who may assert, review, correct or rely on planned arm, cohort, comparison group and participation period, under which authority, purpose and limits? lifecycle
  3. Which event, effective, recorded, ingested and knowledge times apply to planned arm, cohort, comparison group and participation period, and which evidence supports them? classification

Planned visit, activity, intervention, observation and window

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned visit, activity, intervention, observation and window? requirement
  2. Who may assert, review, correct or rely on planned visit, activity, intervention, observation and window, under which authority, purpose and limits? quality
  3. Which event, effective, recorded, ingested and knowledge times apply to planned visit, activity, intervention, observation and window, and which evidence supports them? relationship
Actual participation, safety, adherence and compensation Groups governed participation context for actual participation, safety, adherence and compensation.

Actual activities, exposure, adherence and deviation

Groups source-qualified participation context for actual activities, exposure, adherence and deviation.

Actual visit, activity, intervention, exposure, dose and observation reference

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish actual visit, activity, intervention, exposure, dose and observation reference? evidence
  2. Who may assert, review, correct or rely on actual visit, activity, intervention, exposure, dose and observation reference, under which authority, purpose and limits? security
  3. Which event, effective, recorded, ingested and knowledge times apply to actual visit, activity, intervention, exposure, dose and observation reference, and which evidence supports them? authority

Attendance, adherence, nonadherence, protocol deviation and impact

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish attendance, adherence, nonadherence, protocol deviation and impact? quality
  2. Who may assert, review, correct or rely on attendance, adherence, nonadherence, protocol deviation and impact, under which authority, purpose and limits? retention
  3. Which event, effective, recorded, ingested and knowledge times apply to attendance, adherence, nonadherence, protocol deviation and impact, and which evidence supports them? requirement

Safety, incidents, medical care and compensation

Groups source-qualified participation context for safety, incidents, medical care and compensation.

Safety observation, adverse event, seriousness, causality and report reference

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish safety observation, adverse event, seriousness, causality and report reference? evidence
  2. Who may assert, review, correct or rely on safety observation, adverse event, seriousness, causality and report reference, under which authority, purpose and limits? interoperability
  3. Which event, effective, recorded, ingested and knowledge times apply to safety observation, adverse event, seriousness, causality and report reference, and which evidence supports them? constraint

Research injury, medical care, compensation, reimbursement and payment reference

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish research injury, medical care, compensation, reimbursement and payment reference? relationship
  2. Who may assert, review, correct or rely on research injury, medical care, compensation, reimbursement and payment reference, under which authority, purpose and limits? decision
  3. Which event, effective, recorded, ingested and knowledge times apply to research injury, medical care, compensation, reimbursement and payment reference, and which evidence supports them? event
Status, outcome, withdrawal, follow-up and data use Groups governed participation context for status, outcome, withdrawal, follow-up and data use.

States, milestones, holds and study effects

Groups source-qualified participation context for states, milestones, holds and study effects.

Candidate, screened, eligible, consented, enrolled, active and follow-up state

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish candidate, screened, eligible, consented, enrolled, active and follow-up state? state
  2. Who may assert, review, correct or rely on candidate, screened, eligible, consented, enrolled, active and follow-up state, under which authority, purpose and limits? state
  3. 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? temporal

Milestone, hold, suspension, site closure, study termination and subject effect

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish milestone, hold, suspension, site closure, study termination and subject effect? event
  2. Who may assert, review, correct or rely on milestone, hold, suspension, site closure, study termination and subject effect, under which authority, purpose and limits? identity
  3. 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? composition

Withdrawal, discontinuation, loss, completion and disposition

Groups source-qualified participation context for withdrawal, discontinuation, loss, completion and disposition.

Refusal, withdrawal scope, intervention discontinuation and reason

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish refusal, withdrawal scope, intervention discontinuation and reason? lifecycle
  2. Who may assert, review, correct or rely on refusal, withdrawal scope, intervention discontinuation and reason, under which authority, purpose and limits? classification
  3. Which event, effective, recorded, ingested and knowledge times apply to refusal, withdrawal scope, intervention discontinuation and reason, and which evidence supports them? evidence

Lost to follow-up, completion, off-study, death reference and outcome

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.

  1. 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? state
  2. 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? relationship
  3. 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? ownership
Privacy, de-identification, correction, retention and interoperability Groups governed participation context for privacy, de-identification, correction, retention and interoperability.

Data or specimen use, privacy and linkage

Groups source-qualified participation context for data or specimen use, privacy and linkage.

Data, specimen, future contact, secondary use, withdrawal and retention scope

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish data, specimen, future contact, secondary use, withdrawal and retention scope? privacy
  2. Who may assert, review, correct or rely on data, specimen, future contact, secondary use, withdrawal and retention scope, under which authority, purpose and limits? authority
  3. 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? measurement

Pseudonymization, de-identification, linkage, re-identification risk and authority

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish pseudonymization, de-identification, linkage, re-identification risk and authority? security
  2. Who may assert, review, correct or rely on pseudonymization, de-identification, linkage, re-identification risk and authority, under which authority, purpose and limits? requirement
  3. Which event, effective, recorded, ingested and knowledge times apply to pseudonymization, de-identification, linkage, re-identification risk and authority, and which evidence supports them? exception

Access, correction, retention and projections

Groups source-qualified participation context for access, correction, retention and projections.

Role, purpose, access, disclosure, audit, correction, hold and disposition

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish role, purpose, access, disclosure, audit, correction, hold and disposition? access
  2. Who may assert, review, correct or rely on role, purpose, access, disclosure, audit, correction, hold and disposition, under which authority, purpose and limits? constraint
  3. Which event, effective, recorded, ingested and knowledge times apply to role, purpose, access, disclosure, audit, correction, hold and disposition, and which evidence supports them? provenance

FHIR, CDISC, WHO, ClinicalTrials registry projection, version and loss

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.

  1. What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish fhir, cdisc, who, clinicaltrials registry projection, version and loss? interoperability
  2. Who may assert, review, correct or rely on fhir, cdisc, who, clinicaltrials registry projection, version and loss, under which authority, purpose and limits? event
  3. Which event, effective, recorded, ingested and knowledge times apply to fhir, cdisc, who, clinicaltrials registry projection, version and loss, and which evidence supports them? process

Classifiers Filled

Family
World Models
Category
Activities and processes
Entry kind
aggregate
Navigation path
NAV.ACT.RES
Domain
ACT.RES
Industry
Cross-industry
Tags
researchsubjectparticipantact.res

What it is Filled

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.

In scope

  • 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 of scope

  • 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

Why it exists Filled

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.

Distinguishing features Filled

  • 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.

What robots and AI may and may not do Filled

Must not

  • 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.

Only with a human decision

  • Eligibility decisions and enrolment.
  • Unblinding for safety reasons.
  • Handling withdrawal of consent and its effect on retained data.

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.

Moral aspects Filled

  • 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.

Who is affected

  • Research participants and their representatives
  • Investigators and ethics committees
  • Animals used in research

Owners Filled

Steward

Dimension owner and research-processing mandate

Roles

Research participant or authorized representative
Exercise applicable information, permission, refusal, withdrawal and rights processes without being treated as the data owner by default.
Principal investigator and site investigator
Own qualified subject protection, clinical oversight, protocol conduct and source-qualified decisions within delegation.
Sponsor and research owner
Own study purpose, quality system, oversight, risk management and accountable trial responsibilities.
IRB or independent ethics committee
Provide independent ethical review and continuing oversight according to applicable rules.
Research coordinator and delegated staff
Perform documented recruitment, screening, consent support, visits and data capture within delegated scope.
Safety and medical monitor
Review safety evidence and perform authorized reporting and medical escalation without autonomous agent substitution.
Privacy, data and records steward
Own protected views, linkage controls, data use, disclosures, corrections, holds, retention and auditability.

Links to other meta-models Filled

references

  • WM-ACT-036 Research Study - Bind candidate parent study membership without owning study governance, protocol or results.
  • Person, animal, organization, specimen, device or product subject model - Resolve who or what participates while preserving the external subject lifecycle.
  • Protocol, ethics, consent, criterion, intervention, observation, adverse-event, care, payment, identity-linkage, provenance, audit and records models - Resolve authoritative research and evidence records without absorbing their ownership or lifecycle.

aligned

  • FHIR R5, CDISC ODM 2.0, CDASHIG 2.2, WHO TRDS 1.3.1 and ClinicalTrials.gov - Project version-pinned clinical and registry views with maturity, scope and information-loss declarations.

neighbor

  • WM-ACT-036 Research Study - 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.
  • Person, animal, organization, specimen, device and product subject models - External masters own the subject and its general lifecycle. This aggregate owns only the study-specific participation profile, identifiers and typed reference.
  • Consent, assent and representative-permission artifacts - External repositories own source artifacts and legal or ethical validity. Participation stores versioned bindings, process, scope, actors, verification, state and times.
  • Intervention, observation, adverse event, medical-care and payment models - External masters own clinical, behavioral, safety, care and financial records. Participation stores typed planned or actual links and bounded interpretations.
  • Identity linkage, privacy and records systems - 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.
  • FHIR, CDISC, WHO and ClinicalTrials.gov - These are versioned healthcare, clinical-data and public study-level projections with different scopes and maturity. No mapping is universally applicable or assumed lossless.

parent

  • WM-ACT-036

What else AI and robots need to interact with it Filled

Identity and identifiers required Filled

  • 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.

Direct properties not applicable Not applicable

Not applicable

Institutional or informational subject: no invented physical properties.

Recognition optional Filled

  • 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 and actions required Filled

  • 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 and failure modes required Filled

  • Enrolment without valid consent.
  • Accidental unblinding.
  • Re-identification of participants from released data.
  • Lost follow-up of a subject with a safety event.

Standards and interfaces required Filled

  • 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 of use required Filled

  • 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 Filled

  1. ICH E6(R3) Guideline for Good Clinical Practice - International Council for Harmonisation
  2. ICH E8(R1) General Considerations for Clinical Studies - International Council for Harmonisation
  3. WMA Declaration of Helsinki - World Medical Association
  4. 45 CFR Part 46 Protection of Human Subjects - United States Office of the Federal Register
  5. The Belmont Report - United States Department of Health and Human Services
  6. Regulation (EU) No 536/2014 on clinical trials - European Union
  7. WHO Trial Registration Data Set - World Health Organization
  8. FHIR R5 ResearchSubject - HL7 International
  9. FHIR R5 ResearchStudy - HL7 International
  10. FHIR R5 Consent - HL7 International
  11. Operational Data Model - Clinical Data Interchange Standards Consortium
  12. CDASH Implementation Guide - Clinical Data Interchange Standards Consortium
  13. ISO 14155 Clinical investigation of medical devices for human subjects - International Organization for Standardization
  14. HIPAA de-identification guidance - United States Department of Health and Human Services
  15. PROV-O: The PROV Ontology - World Wide Web Consortium
  16. Regulation (EU) 2016/679 General Data Protection Regulation - European Union
  17. Date and Time on the Internet: Timestamps - Internet Engineering Task Force
  18. ClinicalTrials.gov Study Data Structure - United States National Library of Medicine

Open questions

  • 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.

Machine files

Card as JSON Specification AGENTS.md Source Card backlog vercy.card/1

Provenance

world-models research · reviewable-draft

Built from: models/wm-act-054-research-subject-participant/spec.yaml, ver-cy/world-models/card-supplements/wm-act-054-research-subject-participant.json