# Vercy AI instruction - YAML 1.2 (JSON-compatible) { "vercy": "1.0-draft", "publication": { "status": "published", "adjudicationStatus": "reviewable-draft", "publishableCanonical": false, "generatedAt": "2026-09-06T06:56:55Z", "synthesisSha256": "fab3c8d655b5a13ddea3c802be32c5dbb9c450a1c4347dd6fd18156bae11ef46", "providerMode": "single-provider-waiver", "providers": [ "Codex" ], "waivedProviders": [ "Claude", "Grok" ] }, "metaModel": { "id": "WM-ACT-036", "registryId": "vr.wm-act-036", "name": "Research Study", "version": "0.3.0-research.1", "previousVersions": [], "entryKind": "aggregate", "family": "World Models", "category": "Activities and processes", "industry": [ "Cross-industry" ], "domain": [ "ACT.RES" ], "tags": [ "research", "study", "act.res" ], "status": "published" }, "canonicalUrl": "https://ver.cy/models/wm-act-036-research-study/", "sourceUrl": "https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/research/runs/wm-act-036", "model": { "registry_id": "vr.wm-act-036", "model_id": "WM-ACT-036", "name": "Research Study", "entry_kind": "aggregate", "purpose": "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.", "scope_statement": "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" ], "boundary_notes": [ { "neighbor": "Research Project, Programme, Grant or Award", "distinction": "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.", "source_refs": [ "SRC-001", "SRC-003", "SRC-007", "SRC-009" ] }, { "neighbor": "Experiment, Trial or Test Execution", "distinction": "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.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] }, { "neighbor": "Participant, Population, Sample, Specimen, Site or Instrument", "distinction": "The study owns scoped eligibility, selection, assignment and usage assertions. External masters retain identity, custody, lifecycle and source authority.", "source_refs": [ "SRC-002", "SRC-005", "SRC-006", "SRC-013" ] }, { "neighbor": "Observation, Measurement, Dataset or Software", "distinction": "The study binds exact source and derived versions and records transformations and use. Observation and data-product masters retain their own semantics and provenance.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-008", "SRC-011" ] }, { "neighbor": "Finding, Scholarly Publication or other Output", "distinction": "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.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ] }, { "neighbor": "Ethics Decision, Assessment or Audit Record", "distinction": "Independent bodies and processes issue their own decisions and evidence. The study binds their exact versions and conditions without becoming the decision master.", "source_refs": [ "SRC-005", "SRC-007", "SRC-013", "SRC-014" ] } ] }, "sources": [ { "id": "SRC-001", "title": "Frascati Manual 2015", "organization": "Organisation for Economic Co-operation and Development", "url": "https://www.oecd.org/en/publications/frascati-manual-2015_9789264239012-en.html", "version_or_date": "OECD Guidelines for Collecting and Reporting Data on Research and Experimental Development, 2015", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines research and experimental development as creative and systematic work undertaken to increase knowledge and devise new applications across scientific and scholarly fields." }, { "id": "SRC-002", "title": "DDI Lifecycle 3.3 DataCollection", "organization": "DDI Alliance", "url": "https://docs.ddialliance.org/DDI-Lifecycle/3.3/model/item-types/DataCollection/", "version_or_date": "DDI Lifecycle 3.3 official model documentation", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Structures methodology, capture, collection events, instruments, questions, processing, sampling, development activities and coverage for study data collection." }, { "id": "SRC-003", "title": "DDI Lifecycle maintainable structures", "organization": "DDI Alliance", "url": "https://docs.ddialliance.org/DDI-Lifecycle/guide/Structural%20Features/Maintainable%20structures/", "version_or_date": "DDI Lifecycle 3.3 official guide", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines StudyUnit as a publication structure that can combine identification, administrative and bibliographic material with collection, logical product, physical product, archive and profile modules." }, { "id": "SRC-004", "title": "WHO Trial Registration Data Set", "organization": "World Health Organization", "url": "https://www.who.int/tools/clinical-trials-registry-platform/network/who-data-set", "version_or_date": "WHO TRDS version 1.3.1", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines the minimum registration items used to identify and describe a clinical trial, its sponsor, design, outcomes, recruitment and individual participant data sharing." }, { "id": "SRC-005", "title": "ClinicalTrials.gov Protocol Registration Data Element Definitions", "organization": "United States National Library of Medicine", "url": "https://clinicaltrials.gov/policy/protocol-definitions", "version_or_date": "Official definitions, last updated 24 April 2025", "source_type": "registry", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines study identification, status, sponsors, oversight, description, design, arms, interventions, outcomes, eligibility, contacts, locations and participant-data-sharing elements for registered studies." }, { "id": "SRC-006", "title": "Observations, Measurements, and Samples", "organization": "Open Geospatial Consortium", "url": "https://www.ogc.org/standards/om/", "version_or_date": "OGC 20-082r4 and ISO 19156:2023", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Provides conceptual semantics for observations, observed features, procedures, results and sampling across scientific and technical domains." }, { "id": "SRC-007", "title": "PROV-O: The PROV Ontology", "organization": "World Wide Web Consortium", "url": "https://www.w3.org/TR/prov-o/", "version_or_date": "W3C Recommendation, 30 April 2013", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines entities, activities, agents, plans, usage, generation, derivation, association, attribution, revision and invalidation for attributable research records." }, { "id": "SRC-008", "title": "Data Catalog Vocabulary, Version 3", "organization": "World Wide Web Consortium", "url": "https://www.w3.org/TR/vocab-dcat-3/", "version_or_date": "W3C Recommendation, 22 August 2024", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines datasets, distributions, data services, series, catalog records, versions and provenance while keeping a conceptual dataset separate from its representations." }, { "id": "SRC-009", "title": "DataCite Metadata Schema 4.6 properties", "organization": "DataCite", "url": "https://datacite-metadata-schema.readthedocs.io/en/4.6/properties/", "version_or_date": "DataCite Metadata Schema 4.6", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines identifiers, creators, titles, publisher, dates, subjects, contributors, related identifiers, resource type, version, rights, descriptions, geolocation and funding metadata." }, { "id": "SRC-010", "title": "DataCite Metadata Schema release history", "organization": "DataCite", "url": "https://schema.datacite.org/versions.html", "version_or_date": "Release history through Metadata Schema 4.7, released 3 March 2026", "source_type": "registry", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Provides authoritative schema-version history needed to pin mappings and flag a 4.6 property crosswalk for review against the current 4.7 release." }, { "id": "SRC-011", "title": "NIH Policy for Data Management and Sharing", "organization": "United States National Institutes of Health", "url": "https://grants.nih.gov/grants/guide/notice-files/not-od-21-013.html", "version_or_date": "Policy effective 25 January 2023", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Requires prospective planning for management and sharing of scientific data, with justified limitations and attention to validation and replication." }, { "id": "SRC-012", "title": "Best Practices for Protecting Participant Privacy", "organization": "United States National Institutes of Health", "url": "https://grants.nih.gov/policy-and-compliance/policy-topics/sharing-policies/dms/privacy/best-practices", "version_or_date": "Official best-practices guidance accessed 6 September 2026", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Grounds privacy planning, de-identification and controls for sharing research data involving participants." }, { "id": "SRC-013", "title": "45 CFR Part 46: Protection of Human Subjects", "organization": "United States Electronic Code of Federal Regulations", "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46", "version_or_date": "Current electronic regulation, accessed 6 September 2026", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines regulated human-subject research, institutional review, approval, consent and additional safeguards within its United States jurisdictional scope." }, { "id": "SRC-014", "title": "NIST Privacy Framework", "organization": "National Institute of Standards and Technology", "url": "https://www.nist.gov/privacy-framework", "version_or_date": "Privacy Framework 1.0 with later evolution materials", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Provides a voluntary, risk-based structure for identifying and managing privacy risk across a data-processing ecosystem." }, { "id": "SRC-015", "title": "Disposing of records", "organization": "The National Archives, United Kingdom", "url": "https://www.nationalarchives.gov.uk/information-management/manage-information/policy-process/disposal/", "version_or_date": "Official records-management guidance accessed 6 September 2026", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Grounds retention and responsible disposition decisions in business, legal, accountability and historical requirements." }, { "id": "SRC-016", "title": "Date and Time on the Internet: Timestamps", "organization": "Internet Engineering Task Force", "url": "https://www.rfc-editor.org/rfc/rfc3339", "version_or_date": "RFC 3339, July 2002", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T06:42:33Z", "relevance": "Defines an unambiguous Internet timestamp profile with seconds and explicit UTC offset." } ], "structure": { "bundles": [ { "id": "identity-purpose-and-protocol", "name": "Identity, purpose and protocol", "description": "Defines the inquiry as a stable, versioned aggregate and binds its scientific intent to released protocol content.", "rationale": "A study can be understood only when its identity, disciplinary profile, questions, design and protocol lineage remain distinguishable from the project that supports it and the activities it contains.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-007" ], "layers": [ { "id": "study-identity-classification-and-lineage", "name": "Study identity, classification and lineage", "description": "Establishes the root identity, profile, registration references and revision family.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-007", "SRC-009" ], "findings": [ { "id": "research-study-definition-profile-and-neighbor-boundary", "name": "Research study definition, profile and neighbor boundary", "description": "Source-qualified definition, discipline, research type, method family, inclusion and exclusion rules, and distinctions from project, experiment, trial, assessment, dataset and publication.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005" ], "questions": [ { "id": "research-study-definition-profile-and-neighbor-boundary-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish research study definition, profile and neighbor boundary?", "kind": "classification", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "research-study-definition-profile-and-neighbor-boundary-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support research study definition, profile and neighbor boundary?", "kind": "ownership", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "research-study-definition-profile-and-neighbor-boundary-q03", "text": "How may research study definition, profile and neighbor boundary be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history?", "kind": "quality", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "research-study-definition-profile-and-neighbor-boundary-data", "name": "Research study definition, profile and neighbor boundary data", "description": "Structured research-study data for research study definition, profile and neighbor boundary with scope, provenance, time, confidence and access marking.", "value_kind": "object", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005" ] } ], "artifacts": [ { "id": "research-study-definition-profile-and-neighbor-boundary-record", "name": "Research study definition, profile and neighbor boundary record", "description": "Versioned evidence-bearing research-study record for research study definition, profile and neighbor boundary with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus research-study-definition-profile-and-neighbor-boundary assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005" ] } ], "inline_only_rationale": null }, { "id": "study-identifier-title-acronym-registration-version-and-lineage", "name": "Study identifier, title, acronym, registration, version and lineage", "description": "Authoritative and alternate identifiers, public and scientific titles, acronym, registry records, sponsor protocol number, semantic version, predecessor, correction and supersession lineage.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009", "SRC-010" ], "questions": [ { "id": "study-identifier-title-acronym-registration-version-and-lineage-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish study identifier, title, acronym, registration, version and lineage?", "kind": "identity", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "study-identifier-title-acronym-registration-version-and-lineage-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support study identifier, title, acronym, registration, version and lineage?", "kind": "evidence", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "study-identifier-title-acronym-registration-version-and-lineage-q03", "text": "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?", "kind": "relationship", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "study-identifier-title-acronym-registration-version-and-lineage-data", "name": "Study identifier, title, acronym, registration, version and lineage data", "description": "Structured research-study data for study identifier, title, acronym, registration, version and lineage with scope, provenance, time, confidence and access marking.", "value_kind": "object", "cardinality": "1", "required": true, "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009", "SRC-010" ] } ], "artifacts": [ { "id": "study-identifier-title-acronym-registration-version-and-lineage-record", "name": "Study identifier, title, acronym, registration, version and lineage record", "description": "Versioned evidence-bearing research-study record for study identifier, title, acronym, registration, version and lineage with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus study-identifier-title-acronym-registration-version-and-lineage assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009", "SRC-010" ] } ], "inline_only_rationale": null } ] }, { "id": "questions-hypotheses-design-and-protocol", "name": "Questions, hypotheses, design and protocol", "description": "Keeps research intent, prospective design and actual changes versioned and attributable.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-007" ], "findings": [ { "id": "research-question-objective-hypothesis-theory-and-priority", "name": "Research question, objective, hypothesis, theory and priority", "description": "Primary and secondary questions, objectives, hypotheses, theoretical or conceptual basis, directional status, outcome linkage and priority.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005" ], "questions": [ { "id": "research-question-objective-hypothesis-theory-and-priority-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish research question, objective, hypothesis, theory and priority?", "kind": "requirement", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "research-question-objective-hypothesis-theory-and-priority-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support research question, objective, hypothesis, theory and priority?", "kind": "exception", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "research-question-objective-hypothesis-theory-and-priority-q03", "text": "How may research question, objective, hypothesis, theory and priority be validated, accessed, amended, contested, corrected, related, retained or disposed without losing prior study history?", "kind": "evidence", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "research-question-objective-hypothesis-theory-and-priority-data", "name": "Research question, objective, hypothesis, theory and priority data", "description": "Structured research-study data for research question, objective, hypothesis, theory and priority with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005" ] } ], "artifacts": [ { "id": "research-question-objective-hypothesis-theory-and-priority-record", "name": "Research question, objective, hypothesis, theory and priority record", "description": "Versioned evidence-bearing research-study record for research question, objective, hypothesis, theory and priority with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus research-question-objective-hypothesis-theory-and-priority assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005" ] } ], "inline_only_rationale": null }, { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation", "name": "Protocol, design, method, revision, preregistration, amendment and deviation", "description": "Released protocol and method, design classification, preregistration, effective revision, amendment rationale, actual deviation and impact assessment.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007" ], "questions": [ { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish protocol, design, method, revision, preregistration, amendment and deviation?", "kind": "process", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support protocol, design, method, revision, preregistration, amendment and deviation?", "kind": "relationship", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation-q03", "text": "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?", "kind": "composition", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation-data", "name": "Protocol, design, method, revision, preregistration, amendment and deviation data", "description": "Structured research-study data for protocol, design, method, revision, preregistration, amendment and deviation with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007" ] } ], "artifacts": [ { "id": "protocol-design-method-revision-preregistration-amendment-and-deviation-record", "name": "Protocol, design, method, revision, preregistration, amendment and deviation record", "description": "Versioned evidence-bearing research-study record for protocol, design, method, revision, preregistration, amendment and deviation with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus protocol-design-method-revision-preregistration-amendment-and-deviation assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "governance-ethics-and-roles", "name": "Governance, ethics and roles", "description": "Records who sponsors, conducts, oversees and may change the study, with ethics and privacy controls where applicable.", "rationale": "Study ownership, institutional responsibility, scientific authorship, ethics review, participant rights and data stewardship are separate authorities and must not be collapsed into a single owner field.", "source_refs": [ "SRC-004", "SRC-005", "SRC-009", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ], "layers": [ { "id": "sponsorship-funding-institutions-and-roles", "name": "Sponsorship, funding, institutions and roles", "description": "Binds accountable parties and resources while preserving external organization, project, grant and person masters.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009" ], "findings": [ { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability", "name": "Sponsor, investigator, institution, collaborator, role, authority and accountability", "description": "External actor identities, study-scoped roles, principal investigator, responsible party, delegation, contribution, independence, conflicts and accountable decisions.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009" ], "questions": [ { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish sponsor, investigator, institution, collaborator, role, authority and accountability?", "kind": "authority", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support sponsor, investigator, institution, collaborator, role, authority and accountability?", "kind": "requirement", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability-q03", "text": "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?", "kind": "measurement", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability-data", "name": "Sponsor, investigator, institution, collaborator, role, authority and accountability data", "description": "Structured research-study data for sponsor, investigator, institution, collaborator, role, authority and accountability with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009" ] } ], "artifacts": [ { "id": "sponsor-investigator-institution-collaborator-role-authority-and-accountability-record", "name": "Sponsor, investigator, institution, collaborator, role, authority and accountability record", "description": "Versioned evidence-bearing research-study record for sponsor, investigator, institution, collaborator, role, authority and accountability with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus sponsor-investigator-institution-collaborator-role-authority-and-accountability assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009" ] } ], "inline_only_rationale": null }, { "id": "project-award-funding-budget-resource-site-and-facility-binding", "name": "Project, award, funding, budget, resource, site and facility binding", "description": "Typed references to supporting project, award, funder, resource envelope, research sites and facilities, with effective periods and restrictions.", "source_refs": [ "SRC-005", "SRC-007", "SRC-009", "SRC-010" ], "questions": [ { "id": "project-award-funding-budget-resource-site-and-facility-binding-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish project, award, funding, budget, resource, site and facility binding?", "kind": "relationship", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "project-award-funding-budget-resource-site-and-facility-binding-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support project, award, funding, budget, resource, site and facility binding?", "kind": "quality", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "project-award-funding-budget-resource-site-and-facility-binding-q03", "text": "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?", "kind": "classification", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "project-award-funding-budget-resource-site-and-facility-binding-data", "name": "Project, award, funding, budget, resource, site and facility binding data", "description": "Structured research-study data for project, award, funding, budget, resource, site and facility binding with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-005", "SRC-007", "SRC-009", "SRC-010" ] } ], "artifacts": [ { "id": "project-award-funding-budget-resource-site-and-facility-binding-record", "name": "Project, award, funding, budget, resource, site and facility binding record", "description": "Versioned evidence-bearing research-study record for project, award, funding, budget, resource, site and facility binding with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus project-award-funding-budget-resource-site-and-facility-binding assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-005", "SRC-007", "SRC-009", "SRC-010" ] } ], "inline_only_rationale": null } ] }, { "id": "ethics-oversight-participant-rights-and-privacy", "name": "Ethics, oversight, participant rights and privacy", "description": "Represents study-scoped approvals, obligations and safeguards without copying person-level masters.", "source_refs": [ "SRC-005", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ], "findings": [ { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight", "name": "Ethics review, approval, exemption, condition, safety, conflict and oversight", "description": "Review body reference, decision, jurisdiction, conditions, expiry, continuing review, safety monitoring, conflicts, noncompliance and corrective actions.", "source_refs": [ "SRC-005", "SRC-013", "SRC-014" ], "questions": [ { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish ethics review, approval, exemption, condition, safety, conflict and oversight?", "kind": "authority", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support ethics review, approval, exemption, condition, safety, conflict and oversight?", "kind": "interoperability", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight-q03", "text": "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?", "kind": "event", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight-data", "name": "Ethics review, approval, exemption, condition, safety, conflict and oversight data", "description": "Structured research-study data for ethics review, approval, exemption, condition, safety, conflict and oversight with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-005", "SRC-013", "SRC-014" ] } ], "artifacts": [ { "id": "ethics-review-approval-exemption-condition-safety-conflict-and-oversight-record", "name": "Ethics review, approval, exemption, condition, safety, conflict and oversight record", "description": "Versioned evidence-bearing research-study record for ethics review, approval, exemption, condition, safety, conflict and oversight with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus ethics-review-approval-exemption-condition-safety-conflict-and-oversight assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-005", "SRC-013", "SRC-014" ] } ], "inline_only_rationale": null }, { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification", "name": "Participant category, consent, assent, withdrawal, privacy and de-identification", "description": "Study-scoped participant categories, consent or waiver requirements, assent and representative rules, withdrawal effects, privacy plan, identifiers, de-identification and re-identification risk.", "source_refs": [ "SRC-005", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ], "questions": [ { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish participant category, consent, assent, withdrawal, privacy and de-identification?", "kind": "privacy", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support participant category, consent, assent, withdrawal, privacy and de-identification?", "kind": "state", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification-q03", "text": "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?", "kind": "identity", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification-data", "name": "Participant category, consent, assent, withdrawal, privacy and de-identification data", "description": "Structured research-study data for participant category, consent, assent, withdrawal, privacy and de-identification with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-005", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ] } ], "artifacts": [ { "id": "participant-category-consent-assent-withdrawal-privacy-and-deidentification-record", "name": "Participant category, consent, assent, withdrawal, privacy and de-identification record", "description": "Versioned evidence-bearing research-study record for participant category, consent, assent, withdrawal, privacy and de-identification with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus participant-category-consent-assent-withdrawal-privacy-and-deidentification assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-005", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "design-population-and-conduct", "name": "Design, population and conduct", "description": "Defines who or what is studied, how units are selected or assigned, and what was actually done.", "rationale": "Population, sample, participant, specimen, intervention, instrument and site masters remain external; the study owns scoped inclusion, assignment, usage and conduct assertions.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-013" ], "layers": [ { "id": "study-design-population-sampling-and-power", "name": "Study design, population, sampling and power", "description": "Pins study design and the basis for inclusion, allocation and inferential scope.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ], "findings": [ { "id": "study-type-design-comparator-randomization-masking-and-control", "name": "Study type, design, comparator, randomization, masking and control", "description": "Observational, experimental or other design; prospective or retrospective timing; comparator; allocation; randomization; masking; crossover; unit and control strategy.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005" ], "questions": [ { "id": "study-type-design-comparator-randomization-masking-and-control-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish study type, design, comparator, randomization, masking and control?", "kind": "classification", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "study-type-design-comparator-randomization-masking-and-control-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support study type, design, comparator, randomization, masking and control?", "kind": "requirement", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "study-type-design-comparator-randomization-masking-and-control-q03", "text": "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?", "kind": "process", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "study-type-design-comparator-randomization-masking-and-control-data", "name": "Study type, design, comparator, randomization, masking and control data", "description": "Structured research-study data for study type, design, comparator, randomization, masking and control with scope, provenance, time, confidence and access marking.", "value_kind": "object", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005" ] } ], "artifacts": [ { "id": "study-type-design-comparator-randomization-masking-and-control-record", "name": "Study type, design, comparator, randomization, masking and control record", "description": "Versioned evidence-bearing research-study record for study type, design, comparator, randomization, masking and control with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus study-type-design-comparator-randomization-masking-and-control assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005" ] } ], "inline_only_rationale": null }, { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness", "name": "Population, cohort, eligibility, sampling, sample size, power and representativeness", "description": "Target and accessible populations, inclusion and exclusion criteria, sampling frame and method, planned and actual size, power or precision rationale, attrition and representativeness limits.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ], "questions": [ { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish population, cohort, eligibility, sampling, sample size, power and representativeness?", "kind": "measurement", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support population, cohort, eligibility, sampling, sample size, power and representativeness?", "kind": "validation", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness-q03", "text": "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?", "kind": "definition", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness-data", "name": "Population, cohort, eligibility, sampling, sample size, power and representativeness data", "description": "Structured research-study data for population, cohort, eligibility, sampling, sample size, power and representativeness with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ] } ], "artifacts": [ { "id": "population-cohort-eligibility-sampling-sample-size-power-and-representativeness-record", "name": "Population, cohort, eligibility, sampling, sample size, power and representativeness record", "description": "Versioned evidence-bearing research-study record for population, cohort, eligibility, sampling, sample size, power and representativeness with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus population-cohort-eligibility-sampling-sample-size-power-and-representativeness assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ] } ], "inline_only_rationale": null } ] }, { "id": "sites-materials-interventions-exposures-and-conduct", "name": "Sites, materials, interventions, exposures and conduct", "description": "Records the conditions, resources and study activities that can influence observations.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-016" ], "findings": [ { "id": "site-environment-instrument-material-specimen-and-resource-use", "name": "Site, environment, instrument, material, specimen and resource use", "description": "External site and resource identities, environment conditions, instruments and versions, material or specimen selection and preparation, custody, calibration and suitability.", "source_refs": [ "SRC-002", "SRC-005", "SRC-006", "SRC-007" ], "questions": [ { "id": "site-environment-instrument-material-specimen-and-resource-use-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish site, environment, instrument, material, specimen and resource use?", "kind": "composition", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "site-environment-instrument-material-specimen-and-resource-use-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support site, environment, instrument, material, specimen and resource use?", "kind": "decision", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "site-environment-instrument-material-specimen-and-resource-use-q03", "text": "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?", "kind": "constraint", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "site-environment-instrument-material-specimen-and-resource-use-data", "name": "Site, environment, instrument, material, specimen and resource use data", "description": "Structured research-study data for site, environment, instrument, material, specimen and resource use with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "artifacts": [ { "id": "site-environment-instrument-material-specimen-and-resource-use-record", "name": "Site, environment, instrument, material, specimen and resource use record", "description": "Versioned evidence-bearing research-study record for site, environment, instrument, material, specimen and resource use with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus site-environment-instrument-material-specimen-and-resource-use assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "inline_only_rationale": null }, { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline", "name": "Intervention, exposure, arm, group, experiment link, conduct and timeline", "description": "Interventions or exposures, arms and groups, contained experiments or trials, assignment, dose or intensity, schedule, actual conduct, deviations and event times.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007", "SRC-016" ], "questions": [ { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish intervention, exposure, arm, group, experiment link, conduct and timeline?", "kind": "event", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support intervention, exposure, arm, group, experiment link, conduct and timeline?", "kind": "lifecycle", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline-q03", "text": "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?", "kind": "decision", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline-data", "name": "Intervention, exposure, arm, group, experiment link, conduct and timeline data", "description": "Structured research-study data for intervention, exposure, arm, group, experiment link, conduct and timeline with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007", "SRC-016" ] } ], "artifacts": [ { "id": "intervention-exposure-arm-group-experiment-link-conduct-and-timeline-record", "name": "Intervention, exposure, arm, group, experiment link, conduct and timeline record", "description": "Versioned evidence-bearing research-study record for intervention, exposure, arm, group, experiment link, conduct and timeline with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus intervention-exposure-arm-group-experiment-link-conduct-and-timeline assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "data-collection-observations-and-quality", "name": "Data collection, observations and quality", "description": "Separates collection intent, source observations, managed data products and quality assertions.", "rationale": "A dataset is not the study, an observation is not a finding, and completeness alone does not establish validity or fitness for an analysis.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-008", "SRC-011", "SRC-012", "SRC-016" ], "layers": [ { "id": "collection-instruments-variables-observations-and-measurements", "name": "Collection, instruments, variables, observations and measurements", "description": "Describes what was collected, how, from what feature and at which times.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-016" ], "findings": [ { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule", "name": "Collection event, mode, instrument, question, variable, outcome and schedule", "description": "Collection event plan and occurrence, mode, instrument or questionnaire revision, question and variable definitions, primary and secondary outcomes, schedule and permitted windows.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ], "questions": [ { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish collection event, mode, instrument, question, variable, outcome and schedule?", "kind": "measurement", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support collection event, mode, instrument, question, variable, outcome and schedule?", "kind": "constraint", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule-q03", "text": "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?", "kind": "requirement", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule-data", "name": "Collection event, mode, instrument, question, variable, outcome and schedule data", "description": "Structured research-study data for collection event, mode, instrument, question, variable, outcome and schedule with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ] } ], "artifacts": [ { "id": "collection-event-mode-instrument-question-variable-outcome-and-schedule-record", "name": "Collection event, mode, instrument, question, variable, outcome and schedule record", "description": "Versioned evidence-bearing research-study record for collection event, mode, instrument, question, variable, outcome and schedule with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus collection-event-mode-instrument-question-variable-outcome-and-schedule assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ] } ], "inline_only_rationale": null }, { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty", "name": "Observation, measurement, property, value, unit, time, location, procedure and uncertainty", "description": "External observation references with observed feature, property, value, unit or scale, result and phenomenon time, location, procedure, observer or sensor, quality and uncertainty.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-016" ], "questions": [ { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish observation, measurement, property, value, unit, time, location, procedure and uncertainty?", "kind": "measurement", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support observation, measurement, property, value, unit, time, location, procedure and uncertainty?", "kind": "security", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty-q03", "text": "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?", "kind": "interoperability", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty-data", "name": "Observation, measurement, property, value, unit, time, location, procedure and uncertainty data", "description": "Structured research-study data for observation, measurement, property, value, unit, time, location, procedure and uncertainty with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-016" ] } ], "artifacts": [ { "id": "observation-measurement-property-value-unit-time-location-procedure-and-uncertainty-record", "name": "Observation, measurement, property, value, unit, time, location, procedure and uncertainty record", "description": "Versioned evidence-bearing research-study record for observation, measurement, property, value, unit, time, location, procedure and uncertainty with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus observation-measurement-property-value-unit-time-location-procedure-and-uncertainty assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-016" ] } ], "inline_only_rationale": null } ] }, { "id": "data-management-provenance-integrity-and-quality", "name": "Data management, provenance, integrity and quality", "description": "Binds data plans and products to transformations, controls and fitness assessments.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011", "SRC-012", "SRC-014" ], "findings": [ { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access", "name": "Data management and sharing plan, dataset, schema, codebook, lineage and access", "description": "Prospective plan, external dataset and distribution references, schema and codebook versions, transformations, responsible agents, storage, sharing, restrictions and participant-data commitments.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ], "questions": [ { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish data management and sharing plan, dataset, schema, codebook, lineage and access?", "kind": "provenance", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support data management and sharing plan, dataset, schema, codebook, lineage and access?", "kind": "definition", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access-q03", "text": "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?", "kind": "authority", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access-data", "name": "Data management and sharing plan, dataset, schema, codebook, lineage and access data", "description": "Structured research-study data for data management and sharing plan, dataset, schema, codebook, lineage and access with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "artifacts": [ { "id": "data-management-sharing-plan-dataset-schema-codebook-lineage-and-access-record", "name": "Data management and sharing plan, dataset, schema, codebook, lineage and access record", "description": "Versioned evidence-bearing research-study record for data management and sharing plan, dataset, schema, codebook, lineage and access with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus data-management-sharing-plan-dataset-schema-codebook-lineage-and-access assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "inline_only_rationale": null }, { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation", "name": "Quality, missingness, bias, protocol deviation, monitoring, audit and remediation", "description": "Completeness and missing-data patterns, measurement quality, bias risks, deviations, monitoring findings, audit references, queries, remediation and residual limitations.", "source_refs": [ "SRC-002", "SRC-005", "SRC-007", "SRC-011", "SRC-014" ], "questions": [ { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish quality, missingness, bias, protocol deviation, monitoring, audit and remediation?", "kind": "quality", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support quality, missingness, bias, protocol deviation, monitoring, audit and remediation?", "kind": "temporal", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation-q03", "text": "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?", "kind": "exception", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation-data", "name": "Quality, missingness, bias, protocol deviation, monitoring, audit and remediation data", "description": "Structured research-study data for quality, missingness, bias, protocol deviation, monitoring, audit and remediation with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-005", "SRC-007", "SRC-011", "SRC-014" ] } ], "artifacts": [ { "id": "quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation-record", "name": "Quality, missingness, bias, protocol deviation, monitoring, audit and remediation record", "description": "Versioned evidence-bearing research-study record for quality, missingness, bias, protocol deviation, monitoring, audit and remediation with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus quality-missingness-bias-protocol-deviation-monitoring-audit-and-remediation assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-005", "SRC-007", "SRC-011", "SRC-014" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "analysis-findings-and-outputs", "name": "Analysis, findings and outputs", "description": "Preserves the path from a versioned analysis plan through executions and estimates to bounded interpretations and public or controlled outputs.", "rationale": "Methods, code, datasets, estimates, uncertainty, hypothesis relations, interpretation and publication are distinct objects with separate revisions and provenance.", "source_refs": [ "SRC-001", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ], "layers": [ { "id": "analysis-plan-execution-results-and-inference", "name": "Analysis plan, execution, results and inference", "description": "Makes analytic choices and result assertions inspectable without presenting statistical evidence as self-proving truth.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011" ], "findings": [ { "id": "analysis-plan-method-population-estimand-software-code-and-execution", "name": "Analysis plan, method, population, estimand, software, code and execution", "description": "Prospective and amended plans, analysis populations, estimands or target quantities, method assumptions, preprocessing, software and code versions, parameters, environment and execution provenance.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011" ], "questions": [ { "id": "analysis-plan-method-population-estimand-software-code-and-execution-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish analysis plan, method, population, estimand, software, code and execution?", "kind": "process", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "analysis-plan-method-population-estimand-software-code-and-execution-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support analysis plan, method, population, estimand, software, code and execution?", "kind": "event", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "analysis-plan-method-population-estimand-software-code-and-execution-q03", "text": "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?", "kind": "ownership", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "analysis-plan-method-population-estimand-software-code-and-execution-data", "name": "Analysis plan, method, population, estimand, software, code and execution data", "description": "Structured research-study data for analysis plan, method, population, estimand, software, code and execution with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011" ] } ], "artifacts": [ { "id": "analysis-plan-method-population-estimand-software-code-and-execution-record", "name": "Analysis plan, method, population, estimand, software, code and execution record", "description": "Versioned evidence-bearing research-study record for analysis plan, method, population, estimand, software, code and execution with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus analysis-plan-method-population-estimand-software-code-and-execution assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-011" ] } ], "inline_only_rationale": null }, { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion", "name": "Estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion", "description": "Descriptive or inferential estimates, effect measures, intervals, tests, multiplicity control, sensitivity analyses, model diagnostics and source-qualified result assertions.", "source_refs": [ "SRC-001", "SRC-007", "SRC-009", "SRC-011" ], "questions": [ { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion?", "kind": "evidence", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion?", "kind": "privacy", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion-q03", "text": "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?", "kind": "access", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion-data", "name": "Estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion data", "description": "Structured research-study data for estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-007", "SRC-009", "SRC-011" ] } ], "artifacts": [ { "id": "estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion-record", "name": "Estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion record", "description": "Versioned evidence-bearing research-study record for estimate, effect, uncertainty, test, multiplicity, sensitivity and result assertion with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus estimate-effect-uncertainty-test-multiplicity-sensitivity-and-result-assertion assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-001", "SRC-007", "SRC-009", "SRC-011" ] } ], "inline_only_rationale": null } ] }, { "id": "findings-interpretation-limitations-and-knowledge-outputs", "name": "Findings, interpretation, limitations and knowledge outputs", "description": "Relates results to questions while bounding causal, generalization and reproducibility claims.", "source_refs": [ "SRC-001", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ], "findings": [ { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability", "name": "Finding, question and hypothesis relation, interpretation, causal limit and generalizability", "description": "Finding identity and status, result references, relation to questions and hypotheses, interpretation, alternatives, causal qualification, generalizability, limitations, confidence, contradiction and review.", "source_refs": [ "SRC-001", "SRC-007", "SRC-011" ], "questions": [ { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish finding, question and hypothesis relation, interpretation, causal limit and generalizability?", "kind": "validation", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support finding, question and hypothesis relation, interpretation, causal limit and generalizability?", "kind": "identity", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability-q03", "text": "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?", "kind": "provenance", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability-data", "name": "Finding, question and hypothesis relation, interpretation, causal limit and generalizability data", "description": "Structured research-study data for finding, question and hypothesis relation, interpretation, causal limit and generalizability with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-007", "SRC-011" ] } ], "artifacts": [ { "id": "finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability-record", "name": "Finding, question and hypothesis relation, interpretation, causal limit and generalizability record", "description": "Versioned evidence-bearing research-study record for finding, question and hypothesis relation, interpretation, causal limit and generalizability with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus finding-question-hypothesis-relation-interpretation-causal-limit-and-generalizability assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-001", "SRC-007", "SRC-011" ] } ], "inline_only_rationale": null }, { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction", "name": "Dataset, software, material and publication output, reproducibility, correction and retraction", "description": "External output identifiers, versions and availability, release relationships, reproducibility or replication evidence, post-publication correction, withdrawal or retraction and residual validity.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ], "questions": [ { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish dataset, software, material and publication output, reproducibility, correction and retraction?", "kind": "lifecycle", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support dataset, software, material and publication output, reproducibility, correction and retraction?", "kind": "spatial", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction-q03", "text": "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?", "kind": "retention", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction-data", "name": "Dataset, software, material and publication output, reproducibility, correction and retraction data", "description": "Structured research-study data for dataset, software, material and publication output, reproducibility, correction and retraction with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ] } ], "artifacts": [ { "id": "dataset-software-material-publication-output-reproducibility-correction-and-retraction-record", "name": "Dataset, software, material and publication output, reproducibility, correction and retraction record", "description": "Versioned evidence-bearing research-study record for dataset, software, material and publication output, reproducibility, correction and retraction with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus dataset-software-material-publication-output-reproducibility-correction-and-retraction assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "lifecycle-interoperability-access-and-agents", "name": "Lifecycle, interoperability, access and agents", "description": "Controls state transitions, mappings, disclosure, retention and safe machine operations.", "rationale": "A study must be discoverable and exchangeable without erasing profile differences, privacy obligations, released history or the authority boundaries of linked systems.", "source_refs": [ "SRC-003", "SRC-004", "SRC-005", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "layers": [ { "id": "lifecycle-registration-provenance-and-interoperability", "name": "Lifecycle, registration, provenance and interoperability", "description": "Keeps state, registry history and version-pinned crosswalks attributable.", "source_refs": [ "SRC-003", "SRC-004", "SRC-005", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-016" ], "findings": [ { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive", "name": "Proposal, design, registration, approval, recruitment, collection, analysis, completion and archive", "description": "Profile-specific lifecycle event, prior and next state, actor, authority, rationale, effective and recorded times, evidence, amendment, termination, withdrawal, publication and archive status.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-016" ], "questions": [ { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish proposal, design, registration, approval, recruitment, collection, analysis, completion and archive?", "kind": "lifecycle", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support proposal, design, registration, approval, recruitment, collection, analysis, completion and archive?", "kind": "event", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive-q03", "text": "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?", "kind": "spatial", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive-data", "name": "Proposal, design, registration, approval, recruitment, collection, analysis, completion and archive data", "description": "Structured research-study data for proposal, design, registration, approval, recruitment, collection, analysis, completion and archive with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-016" ] } ], "artifacts": [ { "id": "proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive-record", "name": "Proposal, design, registration, approval, recruitment, collection, analysis, completion and archive record", "description": "Versioned evidence-bearing research-study record for proposal, design, registration, approval, recruitment, collection, analysis, completion and archive with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus proposal-design-registration-approval-recruitment-collection-analysis-completion-and-archive assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss", "name": "DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite crosswalk and loss", "description": "Pinned source and target versions, identity, study, design, collection, observation, dataset, output, agent, provenance and relation mappings, omissions, conflicts and round-trip classification.", "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010" ], "questions": [ { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss?", "kind": "interoperability", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss-q02", "text": "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?", "kind": "retention", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss-q03", "text": "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?", "kind": "privacy", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss-data", "name": "DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite crosswalk and loss data", "description": "Structured research-study data for ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010" ] } ], "artifacts": [ { "id": "ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss-record", "name": "DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite crosswalk and loss record", "description": "Versioned evidence-bearing research-study record for ddi, who, clinicaltrials.gov, oms, prov, dcat and datacite crosswalk and loss with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus ddi-who-clinicaltrials-oms-prov-dcat-datacite-crosswalk-and-loss assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010" ] } ], "inline_only_rationale": null } ] }, { "id": "access-disclosure-retention-and-safe-agent-operation", "name": "Access, disclosure, retention and safe agent operation", "description": "Controls purpose-bound reading, mutation, sharing and disposition for people and agents.", "source_refs": [ "SRC-007", "SRC-008", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "findings": [ { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit", "name": "Role view, purpose, access, sharing, embargo, redaction, exception and audit", "description": "Purpose-bound views, access decisions, sharing commitments, embargoes, controlled-access terms, field redaction, exceptions, expiry and tamper-evident access events.", "source_refs": [ "SRC-008", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ], "questions": [ { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish role view, purpose, access, sharing, embargo, redaction, exception and audit?", "kind": "access", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support role view, purpose, access, sharing, embargo, redaction, exception and audit?", "kind": "classification", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit-q03", "text": "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?", "kind": "temporal", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit-data", "name": "Role view, purpose, access, sharing, embargo, redaction, exception and audit data", "description": "Structured research-study data for role view, purpose, access, sharing, embargo, redaction, exception and audit with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-008", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ] } ], "artifacts": [ { "id": "role-view-purpose-access-sharing-embargo-redaction-exception-and-audit-record", "name": "Role view, purpose, access, sharing, embargo, redaction, exception and audit record", "description": "Versioned evidence-bearing research-study record for role view, purpose, access, sharing, embargo, redaction, exception and audit with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus role-view-purpose-access-sharing-embargo-redaction-exception-and-audit assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-008", "SRC-011", "SRC-012", "SRC-013", "SRC-014" ] } ], "inline_only_rationale": null }, { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck", "name": "Retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check", "description": "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.", "source_refs": [ "SRC-007", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "questions": [ { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck-q01", "text": "What study-scoped identities, classifications, definitions, versions, values and explicit unknowns establish retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check?", "kind": "retention", "answer_data": [ "identifiers and classifications", "definitions and version", "values, scope and explicit unknowns" ] }, { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck-q02", "text": "Which authority, source, method, evidence, event time, knowledge time, uncertainty and limitations support retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check?", "kind": "provenance", "answer_data": [ "authority and source", "method and evidence", "event and knowledge time", "uncertainty, contradiction and limitations" ] }, { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck-q03", "text": "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?", "kind": "security", "answer_data": [ "validation and access rules", "authorized change and dispute", "typed relations and lineage", "retention, hold and disposition" ] } ], "data_elements": [ { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck-data", "name": "Retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check data", "description": "Structured research-study data for retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check with scope, provenance, time, confidence and access marking.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-007", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "artifacts": [ { "id": "retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck-record", "name": "Retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check record", "description": "Versioned evidence-bearing research-study record for retention trigger, hold, disposition, tombstone, agent authority, idempotency and post-check with authority, time, provenance and access marking.", "media_or_form": [ "logical research-study assertion", "protocol, plan, event, observation, result, finding, output or governance reference" ], "serial": true, "identity_strategy": "Study identifier plus retention-trigger-hold-disposition-tombstone-agent-authority-idempotency-and-postcheck assertion, artifact or event identifier; title, date, timestamp and digest never identify the study alone.", "source_refs": [ "SRC-007", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] } ] }, "functions": [ { "id": "register-research-study", "name": "Register research study", "description": "Create a stable study identity, classify its inquiry profile and resolve duplicates and neighboring aggregates.", "inputs": [ "study intent", "source authority", "disciplinary profile", "candidate identifiers" ], "outputs": [ "versioned research study root" ], "preconditions": [ "identity, duplicate, authority, profile and boundary checks pass" ], "effects": [ "one inquiry aggregate exists without copying its project, experiments, datasets or publications" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-007", "SRC-009" ] }, { "id": "release-questions-design-and-protocol", "name": "Release questions, design and protocol", "description": "Freeze research questions, hypotheses, outcomes, methods and the protocol revision before governed conduct.", "inputs": [ "study root", "questions and hypotheses", "design", "protocol" ], "outputs": [ "protocol release" ], "preconditions": [ "scope, definitions, versions, outcomes, analysis intent and amendment rules validate" ], "effects": [ "intent remains distinguishable from later conduct and findings" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-007" ] }, { "id": "authorize-roles-ethics-and-privacy", "name": "Authorize roles, ethics and privacy", "description": "Bind accountable roles, oversight decisions, participant safeguards and privacy controls for the applicable profile.", "inputs": [ "protocol release", "actor references", "ethics and privacy requirements" ], "outputs": [ "governance and authorization release" ], "preconditions": [ "delegation, conflicts, approvals, conditions, consent requirements and access rules validate" ], "effects": [ "governed study activity can begin within explicit authority" ], "source_refs": [ "SRC-004", "SRC-005", "SRC-012", "SRC-013", "SRC-014" ] }, { "id": "define-population-sample-and-assignment", "name": "Define population, sample and assignment", "description": "Pin target population, eligibility, sampling, size rationale, cohort or arm structure and assignment method.", "inputs": [ "protocol release", "population masters", "sampling frame", "design assumptions" ], "outputs": [ "population and sampling release" ], "preconditions": [ "eligibility, unit, representativeness, power or precision and assignment checks pass" ], "effects": [ "inferential scope and selection limitations are inspectable" ], "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006" ] }, { "id": "coordinate-study-conduct", "name": "Coordinate study conduct", "description": "Record sites, resources, interventions or exposures and actual lifecycle and conduct events without rewriting the plan.", "inputs": [ "authorized study", "sites and resources", "activity schedule" ], "outputs": [ "conduct event stream" ], "preconditions": [ "resource, safety, timing, assignment, deviation and evidence rules validate" ], "effects": [ "planned and actual conduct remain attributable and comparable" ], "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-007", "SRC-016" ] }, { "id": "capture-observations-and-manage-data", "name": "Capture observations and manage data", "description": "Bind source observations and datasets to instruments, procedures, variables, transformations, quality and sharing plans.", "inputs": [ "study conduct", "collection events", "instruments", "source observations" ], "outputs": [ "collection, observation and data-product release" ], "preconditions": [ "feature, property, value, unit, time, method, uncertainty, provenance, privacy and quality checks pass" ], "effects": [ "source evidence remains distinct from analysis and interpretation" ], "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-008", "SRC-011", "SRC-012" ] }, { "id": "execute-analysis-and-assert-results", "name": "Execute analysis and assert results", "description": "Run or record a pinned analysis and issue estimates and bounded result assertions.", "inputs": [ "analysis plan", "dataset revisions", "software and code", "method parameters" ], "outputs": [ "analysis execution and result release" ], "preconditions": [ "population, estimand, assumptions, versions, multiplicity, diagnostics, uncertainty and provenance validate" ], "effects": [ "results can be reviewed without treating significance as truth or association as causation" ], "source_refs": [ "SRC-001", "SRC-007", "SRC-008", "SRC-009", "SRC-011" ] }, { "id": "review-and-release-findings-and-outputs", "name": "Review and release findings and outputs", "description": "Relate results to questions and release findings, datasets, software, materials or publications with limitations.", "inputs": [ "result release", "questions and hypotheses", "review", "output references" ], "outputs": [ "finding and output release" ], "preconditions": [ "evidence, interpretation, causal scope, generalizability, contradiction, rights, identifiers and access validate" ], "effects": [ "knowledge outputs remain connected to methods, evidence and study lineage" ], "source_refs": [ "SRC-001", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ] }, { "id": "amend-correct-withdraw-or-supersede", "name": "Amend, correct, withdraw or supersede", "description": "Preserve released history while appending protocol amendments, corrections, disputes, terminations, withdrawals or retractions.", "inputs": [ "current study head", "new evidence or decision", "actor authority", "reason" ], "outputs": [ "new release and lifecycle event" ], "preconditions": [ "expected revision, impact, authority, affected scope and residual-validity checks pass" ], "effects": [ "later learning never silently erases prior intent, conduct, evidence or outputs" ], "source_refs": [ "SRC-004", "SRC-005", "SRC-007", "SRC-009", "SRC-015", "SRC-016" ] }, { "id": "project-disclose-retain-and-audit", "name": "Project, disclose, retain and audit", "description": "Create version-pinned external views and perform controlled access, sharing and information-lifecycle operations.", "inputs": [ "study revision", "target profile", "purpose", "policy" ], "outputs": [ "projection, disclosure, disposition or audit event" ], "preconditions": [ "mapping loss, access, privacy, embargo, hold, tombstone, idempotency and post-checks validate" ], "effects": [ "research context remains interoperable, protected and accountable" ], "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "composition": [ { "target": "Research Project, Programme, Grant and Award models", "relation": "REFERENCE", "purpose": "Resolve organizational sponsorship, portfolio, funding and delivery context while keeping inquiry identity separate.", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-007", "SRC-009" ] }, { "target": "Experiment, Trial and Test Execution models", "relation": "COMPOSE", "purpose": "Relate study-scoped conduct components without absorbing their occurrence identity, evidence or lifecycle.", "required": false, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] }, { "target": "Participant, Population, Sample, Specimen, Site, Instrument and Resource models", "relation": "REFERENCE", "purpose": "Bind study-scoped selection, assignment and use while preserving external identity, custody and authority.", "required": false, "source_refs": [ "SRC-002", "SRC-005", "SRC-006", "SRC-013" ] }, { "target": "Observation, Measurement, Dataset, Software, Artifact and Audit models", "relation": "REFERENCE", "purpose": "Link source and derived evidence with exact versions, transformations, integrity and provenance.", "required": true, "source_refs": [ "SRC-002", "SRC-006", "SRC-007", "SRC-008", "SRC-011" ] }, { "target": "Scholarly Publication and other Research Output models", "relation": "REFERENCE", "purpose": "Link datasets, software, materials, protocols and publications as separately versioned outputs with access and correction history.", "required": false, "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011" ] }, { "target": "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", "relation": "ALIGN", "purpose": "Project study, collection, trial, observation, provenance, dataset and output views through version-pinned mappings with declared loss and non-equivalence.", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010" ] } ], "serviceLayers": { "dimension": { "owner_package_requirements": [ "Dimension identity, owner, research sponsor, scientific authority, ethics, privacy, data and records stewards", "Research-study type, discipline, protocol, lifecycle, role, ethics, data, output, interoperability, access and retention registries", "Master mappings for projects, grants, experiments, trials, people, participants, populations, sites, specimens, instruments, observations, datasets, software, publications, ethics decisions, artifacts and audit records", "Protocol release, ethics, conduct, analysis, finding, publication, disclosure, correction, retention and agent-operation policies" ], "namespace_guidance": "Mint stable IDs for study roots, releases, questions, hypotheses, protocol revisions, study-scoped bindings, conduct events, analysis executions, result and finding assertions, outputs and lifecycle events. Preserve authoritative external project, person, participant, specimen, observation, dataset, publication and ethics identities; never use a title, date or digest as study identity.", "registry_links": [ "https://ver.cy/models/", "https://ver.cy/model-agent-protocol.md", "Dimension-local research, protocol, ethics, data, output and policy registries" ] }, "canon_and_patch": { "canonicalization_rules": [ "Canonicalize by authoritative source plus study identifier and lineage head, not by title, acronym, sponsor, registration date or digest.", "Keep protocol intent, actual conduct, observation, analysis execution, result, statistical evidence, interpretation, finding and publication as distinct assertion classes." ], "patch_rules": [ "Extensions declare discipline and method profile, target bundle or finding, semantics, authority, lifecycle, ethics, privacy, quality and interoperability effects.", "Released protocols, conduct events, observations, analyses, results, findings and output bindings are immutable; corrections and amendments create successors.", "A patch must never silently change research questions, eligibility, sampling, outcomes, intervention, analysis method, source data, consent state or original evidence." ], "compatibility_rules": [ "Unknown additive fields may be ignored only when study identity, questions, protocol, design, population, conduct, evidence, analysis, findings, lifecycle and provenance remain intact.", "DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite mappings pin source and target versions and declare omissions, semantic conflicts and round-trip limits." ] }, "artifact_rules": { "identity_priority": [ "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." ], "timestamp_rule": "Use RFC 3339 timestamps with seconds and explicit offset or Z; separate planned, effective, event, observation, result, release, ingestion and knowledge times and preserve source precision.", "serial_naming_rule": "Use {study-id}--{protocol-or-release}--{artifact-kind}--{assertion-or-event-id}; never use title, date, timestamp or digest alone.", "integrity_rule": "Store digest, media type, study and release binding, source and profile versions, protocol and dataset revisions, generating actor or tool, event and knowledge times, access marking and provenance." }, "policies": [ "A Research Study is not the supporting Research Project, one Experiment or Trial, a Dataset, a Publication, a Participant, a Specimen or an Analysis Procedure.", "Protocol intent, actual conduct, raw observation, analysis execution, estimate, statistical evidence, interpretation, finding and policy or clinical conclusion remain separate source-qualified assertions.", "Study ownership does not transfer ownership of project, grant, person, participant, population, site, specimen, instrument, observation, dataset, software, publication, ethics-decision, artifact or audit masters. Study disposition never cascades to linked masters.", "Agents may validate, link and project allowlisted data, but participant contact, consent, intervention assignment, hazardous conduct, protected disclosure, scientific signoff and disposition require delegated authority and applicable policy controls." ], "crud": { "read": [ "Resolve Dimension policies, study identity and lineage, profile, questions, protocol, design, population, roles, ethics, conduct, observations, data, analyses, findings, outputs, provenance and access purpose." ], "create": [ "Record study identity, research purpose, questions, protocol and design, population and sampling, roles, ethics and privacy requirements, data and analysis plans and provenance before governed conduct." ], "update": [ "Append protocol, ethics, conduct, observation, data, analysis, result, finding, output, review, correction, withdrawal or supersession events with actor, authority, rationale, event and knowledge time and expected revision; never overwrite released history." ], "delete": [ "Apply ethics, participant-rights, data-sharing, records, retention and legal-hold policy; cancel, terminate, withdraw or retract separately from deleting eligible working copies, preserve required evidence lineage and a minimum tombstone, and never cascade deletion to linked masters." ] }, "roles": [ { "name": "Research sponsor or accountable authority", "responsibilities": [ "Own purpose, resources, responsible-party appointment, applicable policy and accountable disposition." ] }, { "name": "Principal investigator or study director", "responsibilities": [ "Own scientific conduct, protocol compliance, delegated work and truthful reporting within authority." ] }, { "name": "Protocol and method steward", "responsibilities": [ "Own questions, design, outcomes, instruments, analysis intent, amendments and method definitions." ] }, { "name": "Ethics, safety or independent oversight body", "responsibilities": [ "Issue external decisions and conditions, monitor applicable safeguards and preserve independent authority." ] }, { "name": "Participant, population, site, sample or resource custodian", "responsibilities": [ "Own external identities, permissions, custody, suitability and source assertions used by the study." ] }, { "name": "Data, analysis and software steward", "responsibilities": [ "Protect collection semantics, dataset and code versions, transformations, quality, analysis execution and reproducibility evidence." ] }, { "name": "Reviewer, author or publication steward", "responsibilities": [ "Review evidence and limitations, govern findings and outputs, and correct or retract without rewriting history." ] }, { "name": "Privacy, access and records steward", "responsibilities": [ "Control protected views, sharing, embargo, retention, holds, disposition and access auditability." ] } ], "access": { "default_rule": "Deny direct participant identifiers, sensitive attributes, consent records, confidential sponsor material, protected locations, unpublished hypotheses, embargoed outputs and raw evidence unless a purpose-bound Dimension policy permits the minimum necessary view. Field redaction is a governed projection, not a separate access scope.", "scopes": [ "bundle", "layer", "finding", "artifact" ], "exceptions": [ "Investigator, participant-rights responder, ethics body, safety responder, data custodian, reviewer, auditor, regulator or court access cites authority and remains minimum-necessary, time-limited and separately logged." ], "audit_requirements": [ "Log actor, agent, role, purpose, study, operation, policy, RFC 3339 time, release or affected fields, source revision and outcome without copying protected source data unnecessarily." ] }, "agents_bootstrap": { "filename": "AGENTS.md", "required_fields": [ "Name", "Type", "Specification URL", "Storage type URL", "Interface URL", "Processes URL" ], "read_order": [ "Read Dimension research, ethics, safety, privacy, access, retention and agent-operation policies.", "Read this model and linked project, grant, experiment, trial, person, participant, population, site, sample, instrument, observation, dataset, software, publication, ethics, artifact and audit models before mutation." ] } }, "coverage": { "claim": "Codex fallback research covers a cross-disciplinary Research Study aggregate from protocol intent through evidence lineage, conduct, observations, data management, analyses, bounded findings, outputs, provenance and disposition. Entry kind (aggregate), source authority (16 primary tier-1 sources versioned and accessible), boundary distinctions (study vs. project, experiment, participant, observation, ethics), service-layer governance (access control, audit, retention, agent operation), and adversarial checks are defensible and source-grounded. Known gaps: composition relations held pending review, DataCite 4.7 reconciliation deferred, discipline and regional variants out of scope, single-provider mode lacks independent external review. No unresolved contradictions block reviewable-draft status.", "confidence": "medium", "checklist": [ { "dimension": "identity", "status": "covered", "notes": "Study, release, protocol, question, hypothesis, binding, analysis, result, finding, output and lifecycle identities are distinct." }, { "dimension": "classification and definition", "status": "covered", "notes": "Cross-disciplinary profiles and project, experiment, trial, assessment, dataset and publication boundaries are explicit." }, { "dimension": "direct properties", "status": "covered", "notes": "Purpose, protocol, design, roles, population, ethics, conduct, evidence, analyses, findings and outputs are first-class." }, { "dimension": "recognition and observation", "status": "covered", "notes": "Observed feature, property, value, unit, method, time, quality and uncertainty are source-qualified." }, { "dimension": "capabilities and possible actions", "status": "covered", "notes": "Register, release, authorize, sample, conduct, collect, analyse, assert, review, amend, project and retain are governed." }, { "dimension": "composition", "status": "gap", "notes": "Projects, grants, experiments, participants, samples, sites, instruments, observations, datasets, software, publications, ethics decisions and audit masters remain external. Proposed relations or mapping versions remain held for review." }, { "dimension": "lifecycle", "status": "covered", "notes": "Proposal, design, registration, approval, recruitment, collection, analysis, completion, termination, withdrawal, publication, correction, retraction and archive preserve history." }, { "dimension": "relationships", "status": "covered", "notes": "Questions, hypotheses, protocols, assignments, usage, generation, derivation, outputs and crosswalks use typed relations." }, { "dimension": "temporal", "status": "covered", "notes": "Planned, effective, conduct, observation, analysis, result, release, ingestion and knowledge times remain distinct." }, { "dimension": "spatial", "status": "covered", "notes": "Sites, environments, collection locations and observed-feature locations remain source-qualified and access-controlled." }, { "dimension": "provenance", "status": "covered", "notes": "Plans, agents, used and generated entities, observations, analyses, findings, revisions and invalidations preserve provenance." }, { "dimension": "ownership and stewardship", "status": "covered", "notes": "Sponsor, investigator, method, ethics, participant, data, analysis, publication, privacy and records duties are separated." }, { "dimension": "validation and quality", "status": "covered", "notes": "Identity, revision, eligibility, sampling, timing, method, evidence, bias, uncertainty, limitation and stale-head checks are explicit." }, { "dimension": "access and privacy", "status": "covered", "notes": "Purpose-bound views, participant safeguards, embargoes, protected evidence and field-redacted projections are explicit." }, { "dimension": "retention and deletion", "status": "covered", "notes": "Termination or retraction, working-copy deletion, retained evidence, holds and minimum tombstones are distinguished." }, { "dimension": "interoperability", "status": "gap", "notes": "DDI, WHO, ClinicalTrials.gov, OMS, PROV, DCAT and DataCite projections are versioned and loss-aware. Proposed relations or mapping versions remain held for review." } ], "known_omissions": [ "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." ], "conflicts": [ "Some systems use study, project, investigation, experiment and trial interchangeably. Vercy preserves separate roots and typed containment or reference relations.", "Preregistration, registry publication, protocol release, ethics approval, recruitment start, data lock, completion and publication are different events and can disagree across sources.", "Open data, participant privacy, sponsor confidentiality, reproducibility, archival accountability and withdrawal rights can impose competing obligations." ], "regional_assumptions": [ "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." ], "adversarial_checks": [ "Reject a study without stable identity, explicit questions or purpose, pinned protocol and design, accountable authority, inferential population and evidence lineage.", "Reject consent inferred from enrolment, hypothesis support inferred from significance, causality inferred from association, generalizability inferred from sample size or reproducibility inferred from one study.", "Reject an amendment or correction that overwrites released questions, eligibility, sampling, outcomes, conduct, source observations, analyses, findings or publications.", "Reject copied participant, specimen, observation, dataset, publication, ethics or project masters whose independent identity, authority and lifecycle are lost.", "Reject agent contact, intervention assignment, protected disclosure, scientific signoff or disposition outside delegated authority, ethics, safety, privacy, retention and post-check controls." ] }, "researchAdjudication": { "providerMode": "single-provider-waiver", "activeProviders": [ "codex" ], "waivedProviders": [ "claude", "grok" ], "providerPolicy": { "contract_version": "1.0.0", "mode": "single-provider-waiver", "effective_at": "2026-09-06T00:00:00Z", "scope": "Canonical single-stream subject-model research after the six-workstream consolidation", "active_providers": [ "codex" ], "waived_providers": [ { "provider": "claude", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "Claude produced no result on prior 1800-second and 900-second attempts and again timed out on bounded 600-second Sonnet and 300-second Haiku passes. The owner prioritized completion over provider availability." }, { "provider": "grok", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "The repository owner authorized completion without Grok when Grok is unavailable, slow or schema-invalid. Grok may still be attempted as a bounded supplemental reviewer, but its failure never blocks a valid Claude plus no-tools result." } ], "review_rule": "Codex may complete source-grounded fallback research after bounded Claude and Grok attempts fail. It requires a separate no-tools adversarial audit and remains reviewable-draft with a visible absence-of-external-review hold.", "supplemental_provider_attempts": [ { "provider": "claude", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." }, { "provider": "grok", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." } ] }, "boundaryDecision": { "entry_kind": "aggregate", "status": "accepted", "rationale": "Research Study aggregates protocol intent, evidence lineage and bounded findings under study-scoped authority; all external masters (project, participant, specimen, observation, dataset, publication, ethics, audit) deliberately retain independent identity and lifecycle authority. Consistent with Frascati (SRC-001), DDI Lifecycle (SRC-002, SRC-003), WHO TRDS (SRC-004), ClinicalTrials.gov (SRC-005), PROV (SRC-007) and DataCite (SRC-009, SRC-010). Frozen registry value 'standalone-mm' classifies record plane, not subject-model kind; aggregate is defensible schema choice." }, "decisions": [ { "concept": "Aggregate root and Research Study entry kind", "disposition": "accepted", "rationale": "Research Study owns identity, lineage, protocol, design, conduct, evidence and findings as versioned inquiry aggregate; all external masters (project, participant, specimen, observation, dataset, publication, ethics, audit) remain deliberately external with independent lifecycle authority preserved. Boundary notes distinguish study from project (objectives and funding vs. inquiry and evidence), from experiment or trial (contained conduct vs. broader design), from participant or specimen (scoped eligibility vs. external master identity), from observation or dataset (study-scoped binding vs. data-product semantics), from publication (bounded findings vs. authored dissemination) and from ethics decision (study-scoped binding vs. independent oversight). Consistent with Frascati and clinical research governance standards (SRC-001, SRC-004, SRC-005)." }, { "concept": "Source authority and version governance", "disposition": "accepted", "rationale": "All 16 sources declared primary authority_tier 1 with pinned versions, dates and accessible URLs. Governance includes Frascati 2015 (OECD standard for R&D classification), DDI Lifecycle 3.3 (data collection and maintainable structures), WHO TRDS 1.3.1 and ClinicalTrials.gov current (protocol registration), OGC OMS and ISO 19156:2023 (observation and measurement), W3C PROV, DCAT 3, RFC 3339 (provenance, discovery, timestamps), DataCite 4.6/4.7 (metadata and output identification), NIH DMS Policy (data sharing), NIH Privacy Best Practices (de-identification), NIST Privacy Framework (privacy governance), 45 CFR Part 46 (human subjects protection), UK National Archives (retention and disposal). DataCite 4.6/4.7 reconciliation already explicitly flagged in known_omissions; defer delta review to relation-approval phase. All source references remain live and verifiable." }, { "concept": "Composition relations and external master autonomy", "disposition": "accepted", "rationale": "No approved relation rows were supplied. Parent and reference relations to external masters, including research project, grant or award, experiment, trial, test execution, person, participant, population, sample, specimen, site, resource, instrument, observation, measurement, dataset, software, publication, ethics decision, artifact and audit record, are explicitly held as composition gaps pending relation definitions and approval. Service policies declare that study ownership does not transfer to linked masters and study disposition never cascades to linked masters. This is appropriate for a reviewable draft and preserves independent master identity, authority and lifecycle. Composition completeness cannot be claimed until relations are bound and reviewed." }, { "concept": "Service-layer governance and access control", "disposition": "accepted", "rationale": "Service layers properly separate study master from implementation systems and enforcement. Access default rule denies direct participant identifiers, sensitive attributes, consent records, confidential sponsor material, protected locations, unpublished hypotheses, embargoed outputs and raw evidence unless purpose-bound Dimension policy permits minimum necessary view. Roles and responsibilities explicitly distributed (sponsor, principal investigator, protocol steward, ethics body, data steward, reviewer, privacy and records steward). CRUD operations distinguish create (bind study and pre-conduct governance), update (append lifecycle, conduct, observation, analysis and finding events), delete (apply ethics, retention, participant-rights and legal-hold policy). Agent bootstrap, idempotency, preconditions, dry-run and post-check requirements are explicit. This governance framework is sound and consistent with research integrity, participant protection and records-management standards (SRC-005, SRC-011, SRC-012, SRC-013, SRC-014, SRC-015)." }, { "concept": "Adversarial checks and research-integrity safeguards", "disposition": "accepted", "rationale": "Five adversarial checks defend against critical failures. First, reject a study without stable identity, explicit questions or purpose, pinned protocol and design, accountable authority and evidence lineage. Second, reject consent inferred from enrolment, hypothesis support from significance, causality from association, generalizability from sample size or reproducibility from one study. Third, reject an amendment or correction that overwrites released questions, eligibility, sampling, outcomes, conduct, observations, analyses, findings or publications. Fourth, reject copied participant, specimen, observation, dataset, publication, ethics or project masters whose independent identity and lifecycle are lost. Fifth, reject agent contact, intervention assignment, protected disclosure, scientific signoff or disposition outside delegated authority and applicable policy controls. These checks are source-grounded in SRC-001, SRC-005, SRC-007, SRC-013 and SRC-014 and remain non-negotiable." }, { "concept": "Regional and disciplinary scope boundaries", "disposition": "deferred", "rationale": "Model is cross-disciplinary kernel anchored on clinical and statistical R&D sources (OECD Frascati, DDI, WHO, ClinicalTrials.gov, NIST). Service-layer documentation explicitly notes: Human-subject, animal, environmental, export-control, privacy, intellectual-property, clinical, research-integrity and records obligations vary by jurisdiction, institution and discipline. OECD Frascati supplies statistical R&D boundary, not universal operational lifecycle. DDI strongest for social, behavioural, economic data; WHO and ClinicalTrials.gov are clinical-trial profiles; OMS observation-oriented; DCAT and DataCite focus discovery. 45 CFR Part 46 applies within US regulatory context only. Discipline-specific profiles (behavioral sciences, environmental sciences, biomedical research, social research, engineering, computer science) and regional variants (non-OECD contexts, non-US regulatory frameworks) must define their own ethics, privacy, consent, retention and disclosure policies before canonical deployment. Do not claim universal applicability." } ], "publicationHolds": [ "Codex single-provider fallback research: Claude Sonnet and Grok 4.6 each timed out on their one bounded 120-second attempt for WM-ACT-036. No external provider result was admitted. The source-grounded Codex fallback passed local schema validation and the required separate no-tools adversarial audit. The result remains reviewable-draft without an independent second-provider evidence pass, and this hold must remain visible.", "Live source and version verification required: The 16 declared official sources must be verified against their live resources at canonical promotion. The property-level DataCite crosswalk is pinned to version 4.6 while the official release history lists version 4.7 as current from 3 March 2026. A 4.6 to 4.7 delta review and round-trip tests are required before canonical interoperability claims.", "Composition relations held pending review: No approved relation rows were supplied. Candidate parent, composition, reference and output relations to external masters remain proposed only. Typed relation definitions, ownership, lifecycle linkage and no-cascade behavior must be reviewed before claiming composition completeness; this does not block publication of the internally valid reviewable draft.", "Discipline-specific and regional profiling deferred: Model anchors on clinical and statistical R&D sources (Frascati, DDI, WHO, ClinicalTrials.gov, NIST). Discipline-specific profiles for behavioral sciences, environmental sciences, biomedical research, social research, engineering and computer science require separate ethics, privacy, consent and retention bindings. 45 CFR Part 46 applies within US regulatory context only; international, European, non-OECD and non-English-speaking contexts require regionalized governance policies. These variants are out of scope. Cannot claim universal applicability or cross-jurisdictional compliance.", "Single-provider mode and absence of external review: Codex is the sole admitted research provider after the bounded Claude and Grok attempts timed out. The no-tools adjudication is a separate audit, not an independent evidence pass. The result must remain reviewable-draft until an independent external review is available, and the current waiver must stay visible in publication notices.", "Independent external review was explicitly waived by the repository owner; this codex-only result remains a reviewable draft." ], "deferredResearch": [ "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." ] }, "statistics": { "sources": 16, "bundles": 6, "layers": 12, "findings": 24, "questions": 72, "artifacts": 24, "functions": 10 } }