Research Study
Represent one governed, versioned inquiry aggregate that pursues declared research questions or hypotheses through a protocol and design, defined populations, materials or phenomena, data collection, analysis and bounded findings.
Bundle → Layer → Finding → Questions Filled
6 bundles · 12 layers · 24 findings · 72 questions
Identity, purpose and protocol Defines the inquiry as a stable, versioned aggregate and binds its scientific intent to released protocol content.
Study identity, classification and lineage
Establishes the root identity, profile, registration references and revision family.
Research study definition, profile and neighbor boundary
Source-qualified definition, discipline, research type, method family, inclusion and exclusion rules, and distinctions from project, experiment, trial, assessment, dataset and publication.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish research study definition, profile and neighbor boundary? classification
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support research study definition, profile and neighbor boundary? ownership
- How may research study definition, profile and neighbor boundary be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? quality
Study identifier, title, acronym, registration, version and lineage
Authoritative and alternate identifiers, public and scientific titles, acronym, registry records, sponsor protocol number, semantic version, predecessor, correction and supersession lineage.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish study identifier, title, acronym, registration, version and lineage? identity
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support study identifier, title, acronym, registration, version and lineage? evidence
- How may study identifier, title, acronym, registration, version and lineage be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? relationship
Questions, hypotheses, design and protocol
Keeps research intent, prospective design and actual changes versioned and attributable.
Research question, objective, hypothesis, theory and priority
Primary and secondary questions, objectives, hypotheses, theoretical or conceptual basis, directional status, outcome linkage and priority.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish research question, objective, hypothesis, theory and priority? requirement
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support research question, objective, hypothesis, theory and priority? exception
- How may research question, objective, hypothesis, theory and priority be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? evidence
Protocol, design, method, revision, preregistration, amendment and deviation
Released protocol and method, design classification, preregistration, effective revision, amendment rationale, actual deviation and impact assessment.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish protocol, design, method, revision, preregistration, amendment and deviation? process
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support protocol, design, method, revision, preregistration, amendment and deviation? relationship
- How may protocol, design, method, revision, preregistration, amendment and deviation be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? composition
Governance, ethics and roles Records who sponsors, conducts, oversees and may change the study, with ethics and privacy controls where applicable.
Sponsorship, funding, institutions and roles
Binds accountable parties and resources while preserving external organization, project, grant and person masters.
Sponsor, investigator, institution, collaborator, role, authority and accountability
External actor identities, study-scoped roles, principal investigator, responsible party, delegation, contribution, independence, conflicts and accountable decisions.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish sponsor, investigator, institution, collaborator, role, authority and accountability? authority
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support sponsor, investigator, institution, collaborator, role, authority and accountability? requirement
- How may sponsor, investigator, institution, collaborator, role, authority and accountability be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? measurement
Project, award, funding, budget, resource, site and facility binding
Typed references to supporting project, award, funder, resource envelope, research sites and facilities, with effective periods and restrictions.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish project, award, funding, budget, resource, site and facility binding? relationship
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support project, award, funding, budget, resource, site and facility binding? quality
- How may project, award, funding, budget, resource, site and facility binding be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? classification
Ethics, oversight, participant rights and privacy
Represents study-scoped approvals, obligations and safeguards without copying person-level masters.
Ethics review, approval, exemption, condition, safety, conflict and oversight
Review body reference, decision, jurisdiction, conditions, expiry, continuing review, safety monitoring, conflicts, noncompliance and corrective actions.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish ethics review, approval, exemption, condition, safety, conflict and oversight? authority
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support ethics review, approval, exemption, condition, safety, conflict and oversight? interoperability
- How may ethics review, approval, exemption, condition, safety, conflict and oversight be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? event
Participant category, consent, assent, withdrawal, privacy and de-identification
Study-scoped participant categories, consent or waiver requirements, assent and representative rules, withdrawal effects, privacy plan, identifiers, de-identification and re-identification risk.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish participant category, consent, assent, withdrawal, privacy and de-identification? privacy
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support participant category, consent, assent, withdrawal, privacy and de-identification? state
- How may participant category, consent, assent, withdrawal, privacy and de-identification be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? identity
Design, population and conduct Defines who or what is studied, how units are selected or assigned, and what was actually done.
Study design, population, sampling and power
Pins study design and the basis for inclusion, allocation and inferential scope.
Study type, design, comparator, randomization, masking and control
Observational, experimental or other design; prospective or retrospective timing; comparator; allocation; randomization; masking; crossover; unit and control strategy.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish study type, design, comparator, randomization, masking and control? classification
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support study type, design, comparator, randomization, masking and control? requirement
- How may study type, design, comparator, randomization, masking and control be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? process
Population, cohort, eligibility, sampling, sample size, power and representativeness
Target and accessible populations, inclusion and exclusion criteria, sampling frame and method, planned and actual size, power or precision rationale, attrition and representativeness limits.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish population, cohort, eligibility, sampling, sample size, power and representativeness? measurement
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support population, cohort, eligibility, sampling, sample size, power and representativeness? validation
- How may population, cohort, eligibility, sampling, sample size, power and representativeness be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? definition
Sites, materials, interventions, exposures and conduct
Records the conditions, resources and study activities that can influence observations.
Site, environment, instrument, material, specimen and resource use
External site and resource identities, environment conditions, instruments and versions, material or specimen selection and preparation, custody, calibration and suitability.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish site, environment, instrument, material, specimen and resource use? composition
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support site, environment, instrument, material, specimen and resource use? decision
- How may site, environment, instrument, material, specimen and resource use be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? constraint
Intervention, exposure, arm, group, experiment link, conduct and timeline
Interventions or exposures, arms and groups, contained experiments or trials, assignment, dose or intensity, schedule, actual conduct, deviations and event times.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish intervention, exposure, arm, group, experiment link, conduct and timeline? event
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support intervention, exposure, arm, group, experiment link, conduct and timeline? lifecycle
- How may intervention, exposure, arm, group, experiment link, conduct and timeline be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? decision
Data collection, observations and quality Separates collection intent, source observations, managed data products and quality assertions.
Collection, instruments, variables, observations and measurements
Describes what was collected, how, from what feature and at which times.
Collection event, mode, instrument, question, variable, outcome and schedule
Collection event plan and occurrence, mode, instrument or questionnaire revision, question and variable definitions, primary and secondary outcomes, schedule and permitted windows.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish collection event, mode, instrument, question, variable, outcome and schedule? measurement
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support collection event, mode, instrument, question, variable, outcome and schedule? constraint
- How may collection event, mode, instrument, question, variable, outcome and schedule be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? requirement
Observation, measurement, property, value, unit, time, location, procedure and uncertainty
External observation references with observed feature, property, value, unit or scale, result and phenomenon time, location, procedure, observer or sensor, quality and uncertainty.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish observation, measurement, property, value, unit, time, location, procedure and uncertainty? measurement
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support observation, measurement, property, value, unit, time, location, procedure and uncertainty? security
- How may observation, measurement, property, value, unit, time, location, procedure and uncertainty be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? interoperability
Data management, provenance, integrity and quality
Binds data plans and products to transformations, controls and fitness assessments.
Data management and sharing plan, dataset, schema, codebook, lineage and access
Prospective plan, external dataset and distribution references, schema and codebook versions, transformations, responsible agents, storage, sharing, restrictions and participant-data commitments.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish data management and sharing plan, dataset, schema, codebook, lineage and access? provenance
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support data management and sharing plan, dataset, schema, codebook, lineage and access? definition
- How may data management and sharing plan, dataset, schema, codebook, lineage and access be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? authority
Quality, missingness, bias, protocol deviation, monitoring, audit and remediation
Completeness and missing-data patterns, measurement quality, bias risks, deviations, monitoring findings, audit references, queries, remediation and residual limitations.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish quality, missingness, bias, protocol deviation, monitoring, audit and remediation? quality
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support quality, missingness, bias, protocol deviation, monitoring, audit and remediation? temporal
- How may quality, missingness, bias, protocol deviation, monitoring, audit and remediation be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? exception
Analysis, findings and outputs Preserves the path from a versioned analysis plan through executions and estimates to bounded interpretations and public or controlled outputs.
Analysis plan, execution, results and inference
Makes analytic choices and result assertions inspectable without presenting statistical evidence as self-proving truth.
Analysis plan, method, population, estimand, software, code and execution
Prospective and amended plans, analysis populations, estimands or target quantities, method assumptions, preprocessing, software and code versions, parameters, environment and execution provenance.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish analysis plan, method, population, estimand, software, code and execution? process
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support analysis plan, method, population, estimand, software, code and execution? event
- How may analysis plan, method, population, estimand, software, code and execution be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? ownership
Estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion
Descriptive or inferential estimates, effect measures, intervals, tests, multiplicity control, sensitivity analyses, model diagnostics and source-qualified result assertions.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion? evidence
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion? privacy
- How may estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? access
Findings, interpretation, limitations and knowledge outputs
Relates results to questions while bounding causal, generalization and reproducibility claims.
Finding, question and hypothesis relation, interpretation, causal limit and generalizability
Finding identity and status, result references, relation to questions and hypotheses, interpretation, alternatives, causal qualification, generalizability, limitations, confidence, contradiction and review.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish finding, question and hypothesis relation, interpretation, causal limit and generalizability? validation
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support finding, question and hypothesis relation, interpretation, causal limit and generalizability? identity
- How may finding, question and hypothesis relation, interpretation, causal limit and generalizability be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? provenance
Dataset, software, material and publication output, reproducibility, correction and retraction
External output identifiers, versions and availability, release relationships, reproducibility or replication evidence, post-publication correction, withdrawal or retraction and residual validity.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish dataset, software, material and publication output, reproducibility, correction and retraction? lifecycle
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support dataset, software, material and publication output, reproducibility, correction and retraction? spatial
- How may dataset, software, material and publication output, reproducibility, correction and retraction be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? retention
Lifecycle, interoperability, access and agents Controls state transitions, mappings, disclosure, retention and safe machine operations.
Lifecycle, registration, provenance and interoperability
Keeps state, registry history and version-pinned crosswalks attributable.
Proposal, design, registration, approval, recruitment, collection, analysis, completion and archive
Profile-specific lifecycle event, prior and next state, actor, authority, rationale, effective and recorded times, evidence, amendment, termination, withdrawal, publication and archive status.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish proposal, design, registration, approval, recruitment, collection, analysis, completion and archive? lifecycle
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support proposal, design, registration, approval, recruitment, collection, analysis, completion and archive? event
- How may proposal, design, registration, approval, recruitment, collection, analysis, completion and archive be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? spatial
DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite crosswalk and loss
Pinned source and target versions, identity, study, design, collection, observation, dataset, output, agent, provenance and relation mappings, omissions, conflicts and round-trip classification.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss? interoperability
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss? retention
- How may ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? privacy
Access, disclosure, retention and safe agent operation
Controls purpose-bound reading, mutation, sharing and disposition for people and agents.
Role view, purpose, access, sharing, embargo, redaction, exception and audit
Purpose-bound views, access decisions, sharing commitments, embargoes, controlled-access terms, field redaction, exceptions, expiry and tamper-evident access events.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish role view, purpose, access, sharing, embargo, redaction, exception and audit? access
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support role view, purpose, access, sharing, embargo, redaction, exception and audit? classification
- How may role view, purpose, access, sharing, embargo, redaction, exception and audit be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? temporal
Retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check
Retention class and trigger, legal or ethics hold, deletion eligibility, minimum tombstone, delegated agent scope, preconditions, dry run, idempotency key, expected revision and post-condition verification.
- What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check? retention
- Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check? provenance
- How may retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history? security
Classifiers Filled
- Family
- World Models
- Category
- Activities and processes
- Entry kind
- aggregate
- Navigation path
- NAV.ACT.RES
- Domain
- ACT.RES
- Industry
- Cross-industry
- Tags
- researchstudyact.res
What it is Filled
Owns study identity and lineage, source-qualified classification, questions and hypotheses, protocol and design releases, study-scoped role, funding, site, ethics and privacy bindings, population and sampling assertions, cohorts, arms, interventions or exposures, conduct events, collection and analysis plans, result and finding assertions, registration and amendment history, output links, limitations, interoperability, access and retention. Research Project, Grant or Award, Experiment or Trial, Test Execution, Person, Participant, Population, Sample or Specimen, Site, Instrument, Observation, Measurement, Dataset, Software, Publication, Ethics Decision, Artifact and Audit masters remain external.
In scope
- Study identity, classification, questions, hypotheses, protocol, design, roles, funding and accountable authority
- Ethics, privacy, population, eligibility, sampling, cohorts, sites, resources, interventions, exposures, conduct, observations and managed data
- Analysis plans and executions, estimates, uncertainty, findings, limitations, registration, outputs, reproducibility, lifecycle, interoperability, access, retention and safe agents
Out of scope
- Independent project, grant, experiment, trial, test execution, person, participant, population, specimen, site, instrument, observation, dataset, software, publication, ethics-decision, artifact or audit master lifecycles
- Inferring consent from participation, causality from association, truth from significance, generalizability from one sample, data fitness from completeness or reproducibility from one study
- Implementing a laboratory, clinical-trial management system, electronic data capture system, statistical environment, repository, ethics board, registry or universal legal-compliance regime
Why it exists Filled
Represent one governed, versioned inquiry aggregate that pursues declared research questions or hypotheses through a protocol and design, defined populations, materials or phenomena, data collection, analysis and bounded findings.
Distinguishing features Filled
- Models one study with its questions, design and protocol, not the funding project or a single experiment.
- Separates protocol intent, conduct, raw observation, analysis, finding and conclusion.
- Binds ethics approvals, consent and privacy terms to the study.
- Links datasets and publications as outputs with their own identity.
What robots and AI may and may not do Filled
Must not
- Change hypotheses or analyses after seeing data without recording it.
- Enroll participants or use data outside the approved consent and ethics scope.
- Present preliminary or exploratory results as confirmed findings.
- Re-identify participants or link data beyond approval.
- Suppress negative or null results.
Only with a human decision
- Protocol amendments and ethics submissions.
- Release of findings and withdrawal or correction of published results.
- Decisions on participant safety, such as stopping a study.
May
- Register a study and its protocol releases.
- Check data collection against the protocol and report deviations.
- Run pre-registered analyses and record results with method versions.
- Prepare data and reporting checklists for review.
Moral aspects Filled
- Participants need informed consent, safety and privacy protection.
- Selective reporting distorts science and harms those who rely on it.
- Fair selection of participants and communities matters for both justice and validity.
Who is affected
- Research participants and communities
- Researchers
- Funders and users of findings
Owners Filled
Steward
Dimension identity, owner, research sponsor, scientific authority, ethics, privacy, data and records stewards
Roles
- Research sponsor or accountable authority
- Own purpose, resources, responsible-party appointment, applicable policy and accountable disposition.
- Principal investigator or study director
- Own scientific conduct, protocol compliance, delegated work and truthful reporting within authority.
- Protocol and method steward
- Own questions, design, outcomes, instruments, analysis intent, amendments and method definitions.
- Ethics, safety or independent oversight body
- Issue external decisions and conditions, monitor applicable safeguards and preserve independent authority.
- Participant, population, site, sample or resource custodian
- Own external identities, permissions, custody, suitability and source assertions used by the study.
- Data, analysis and software steward
- Protect collection semantics, dataset and code versions, transformations, quality, analysis execution and reproducibility evidence.
- Reviewer, author or publication steward
- Review evidence and limitations, govern findings and outputs, and correct or retract without rewriting history.
- Privacy, access and records steward
- Control protected views, sharing, embargo, retention, holds, disposition and access auditability.
Links to other meta-models Filled
references
- Research Project, Programme, Grant and Award models - Resolve organizational sponsorship, portfolio, funding and delivery context while keeping inquiry identity separate.
- Participant, Population, Sample, Specimen, Site, Instrument and Resource models - Bind study-scoped selection, assignment and use while preserving external identity, custody and authority.
- Observation, Measurement, Dataset, Software, Artifact and Audit models - Link source and derived evidence with exact versions, transformations, integrity and provenance.
- Scholarly Publication and other Research Output models - Link datasets, software, materials, protocols and publications as separately versioned outputs with access and correction history.
composes
- Experiment, Trial and Test Execution models - Relate study-scoped conduct components without absorbing their occurrence identity, evidence or lifecycle.
aligned
- DDI Lifecycle 3.3, WHO TRDS 1.3.1, ClinicalTrials.gov protocol definitions, OGC OMS, W3C PROV-O and DCAT 3, and DataCite Metadata Schema - Project study, collection, trial, observation, provenance, dataset and output views through version-pinned mappings with declared loss and non-equivalence.
neighbor
- Research Project, Programme, Grant or Award - These organize objectives, funding, portfolios, schedules and delivery. A study is the inquiry aggregate with questions, protocol, evidence and findings and can be supported by several projects or awards.
- Experiment, Trial or Test Execution - These are contained or referenced conduct components with their own occurrence identity. The study owns broader design and synthesis but does not rewrite their evidence.
- Participant, Population, Sample, Specimen, Site or Instrument - The study owns scoped eligibility, selection, assignment and usage assertions. External masters retain identity, custody, lifecycle and source authority.
- Observation, Measurement, Dataset or Software - The study binds exact source and derived versions and records transformations and use. Observation and data-product masters retain their own semantics and provenance.
- Finding, Scholarly Publication or other Output - A study can issue bounded finding assertions and link released outputs. A publication is a separate authored and disseminated record and may contain claims not controlled by the study master.
- Ethics Decision, Assessment or Audit Record - Independent bodies and processes issue their own decisions and evidence. The study binds their exact versions and conditions without becoming the decision master.
contains
- WM-ACT-022
- WM-ACT-054
What else AI and robots need to interact with it Filled
Identity and identifiers required Filled
- Authoritative master-system study identifier from a registry, institution or sponsor, qualified by source and study class.
- Governed globally resolvable study IRI under a controlled namespace.
- Dimension UUID when no authoritative or governed global identifier exists.
Direct properties not applicable Not applicable
Not applicable
Institutional or informational subject: no invented physical properties.
Recognition optional Filled
- A study has a title, a registered identifier where applicable, a protocol, investigators and ethics approval.
- It is confused with a grant, a project, a dataset, a publication or a single experiment.
Capabilities and actions required Filled
- Register research study: Create a stable study identity, classify its inquiry profile and resolve duplicates and neighboring aggregates.
- Release questions, design and protocol: Freeze research questions, hypotheses, outcomes, methods and the protocol revision before governed conduct.
- Authorize roles, ethics and privacy: Bind accountable roles, oversight decisions, participant safeguards and privacy controls for the applicable profile.
- Define population, sample and assignment: Pin target population, eligibility, sampling, size rationale, cohort or arm structure and assignment method.
- Coordinate study conduct: Record sites, resources, interventions or exposures and actual lifecycle and conduct events without rewriting the plan.
- Capture observations and manage data: Bind source observations and datasets to instruments, procedures, variables, transformations, quality and sharing plans.
- Execute analysis and assert results: Run or record a pinned analysis and issue estimates and bounded result assertions.
- Review and release findings and outputs: Relate results to questions and release findings, datasets, software, materials or publications with limitations.
- Amend, correct, withdraw or supersede: Preserve released history while appending protocol amendments, corrections, disputes, terminations, withdrawals or retractions.
- Project, disclose, retain and audit: Create version-pinned external views and perform controlled access, sharing and information-lifecycle operations.
Hazards and failure modes required Filled
- Harm to participants from unsafe protocols.
- Privacy breach from study data.
- False conclusions from data dredging or protocol deviations.
Standards and interfaces required Filled
- WHO International Clinical Trials Registry Platform (ICTRP) trial registration data set.
- CDISC standards for clinical research data.
- DataCite metadata for study datasets.
- ORCID for researcher identification.
- EQUATOR reporting guidelines such as CONSORT.
Context of use required Filled
- Human-subject, animal, environmental, export-control, privacy, intellectual-property, clinical, research-integrity and records obligations vary by jurisdiction, institution and discipline.
- OECD Frascati supplies a statistical R&D boundary rather than a universal operational lifecycle for every form of scholarship.
- DDI is strongest for social, behavioural and economic data; WHO and ClinicalTrials.gov are clinical-trial profiles; OMS is observation-oriented; DCAT and DataCite focus discovery and outputs.
Sources Filled
- Frascati Manual 2015 - Organisation for Economic Co-operation and Development
- DDI Lifecycle 3.3 DataCollection - DDI Alliance
- DDI Lifecycle maintainable structures - DDI Alliance
- WHO Trial Registration Data Set - World Health Organization
- ClinicalTrials.gov Protocol Registration Data Element Definitions - United States National Library of Medicine
- Observations, Measurements, and Samples - Open Geospatial Consortium
- PROV-O: The PROV Ontology - World Wide Web Consortium
- Data Catalog Vocabulary, Version 3 - World Wide Web Consortium
- DataCite Metadata Schema 4.6 properties - DataCite
- DataCite Metadata Schema release history - DataCite
- NIH Policy for Data Management and Sharing - United States National Institutes of Health
- Best Practices for Protecting Participant Privacy - United States National Institutes of Health
- 45 CFR Part 46: Protection of Human Subjects - United States Electronic Code of Federal Regulations
- NIST Privacy Framework - National Institute of Standards and Technology
- Disposing of records - The National Archives, United Kingdom
- Date and Time on the Internet: Timestamps - Internet Engineering Task Force
Open questions
- Relation definitions and composition mappings: Explicit typed relations to external masters must be formalized with identity strategy, ownership, lifecycle linkage rules and no-cascade semantics. Candidate registry and composition rows remain unapproved and need steward review.
- DataCite 4.6/4.7 interoperability reconciliation: The property-level mapping is pinned to DataCite Metadata Schema 4.6 while the official release history lists version 4.7 as current from 3 March 2026. Reconcile property and cardinality deltas, map relevant changes, verify round-trip fidelity and test the crosswalk with real registry records before canonical promotion.
- Discipline-specific and regional profile variants: Clinical research (ClinicalTrials.gov, WHO TRDS, FDA IND/IDE), statistical R&D (Frascati), behavioral sciences, environmental sciences, biomedical research, social research, engineering and computer science each require discipline-specific protocol, ethics, privacy, consent and retention profiles. US regulatory context (45 CFR Part 46, FDA, HIPAA, NIH DMS) must be separated from European (GDPR, EMA, national ethics boards), international (World Bank, UNICEF), non-OECD and non-English-speaking contexts. Governance policies must be regionalized and require local ethics and legal review.
- Agent operation policies and implementations: AGENTS.md bootstrap structure is defined (Name, Type, Specification URL, Storage type URL, Interface URL, Processes URL) but no concrete agent implementations, delegation authorities, idempotency keys, preconditions, dry-run mode, expected-revision assertions or post-condition verifications are supplied. Separate agent-operation specification required before access, sharing, retention and disposition operations can be delegated to agents. Audit trail and tamper-evidence requirements must be explicit.
- Bidirectional relation verification and master-side study discovery: No reverse mappings provided from external masters (project, experiment, participant, dataset, publication, ethics decision) back to study aggregate. Must verify that study identity is resolvable from external master references and that bidirectional links preserve both study and master autonomy. Cross-system consistency checks and conflict-resolution rules for competing assertions must be defined.
- No successful independent Claude or Grok result was available; disciplinary, statistical, ethics, regional, legal and controlled-data review is required before canonical promotion.
- Research Study has no single universal cross-domain vocabulary. This package defines a shared inquiry kernel and requires discipline and method profiles.
- No approved relation rows were supplied. The registry Experiment or Trial parent link and proposed project, participant, specimen, dataset, publication and output relations remain holds.
- WHO TRDS and ClinicalTrials.gov are clinical-trial profiles and must not be treated as universal requirements for all research.
- The DataCite property crosswalk is pinned to 4.6 while the official release history lists 4.7 as current. A 4.7 delta review is required before canonical interoperability claims.
- 45 CFR Part 46 applies within a United States regulatory context. Other jurisdictions, disciplines and institutions require their own ethics, consent, privacy, safety, retention and disclosure profiles.
Machine files
Provenance
world-models research · reviewable-draft
Built from: models/wm-act-036-research-study/spec.yaml, ver-cy/world-models/card-supplements/wm-act-036-research-study.json