A Turtle/OWL rendering of the CDISC Unified Study Definitions Model (USDM) v4, generated mechanically from the YAML source CDISC publishes at cdisc-org/DDF-RA. Provides class- and attribute-level NCI Thesaurus anchoring via skos:exactMatch, codelist binding annotations, and OWL cardinality restrictions, suitable for SPARQL navigation of the USDM v4 model.
Forsberg, K. (2026). usdm-rdf: A Turtle/OWL rendering of CDISC USDM v4. https://w3id.org/cdisc/usdm/v4/
USDM v4 is published by CDISC as a self-describing YAML at Deliverables/UML/dataStructure.yml in the cdisc-org/DDF-RA repository. The YAML carries class- and attribute-level NCI C-Codes, preferred terms, definitions, cardinality, the composition-vs-reference (Value/Ref) distinction, inheritance, and the model-name-vs-serialization-key separation. This RDF/OWL view exposes those facts mechanically, anchored to NCI EVS Thesaurus IRIs. Codelist bindings come from sheet 1 of USDM_CT.xlsx and are rendered as usdm:boundCodelist annotations on Code-typed properties.
Mechanical conversion of CDISC USDM v4 dataStructure.yml. Draft — not normative.
CDISC publishes USDM v4 as a self-describing YAML at Deliverables/UML/dataStructure.yml in cdisc-org/DDF-RA. That YAML already carries class- and attribute-level NCI C-Codes, preferred terms, definitions, cardinality, the composition-vs-reference distinction, inheritance, and a separation between the model name and the serialization key. The gap between published USDM and a queryable RDF/OWL view is therefore mechanical, not semantic. This ontology closes that gap with a small reproducible pipeline producing a single Turtle deliverable.
A brief written record relevant to the abbreviation.
A USDM relationship between the Activity and BiomedicalConceptCategory classes which identifies the set of biomedical concept categories associated with the activity.
A USDM relationship between the Activity and BiomedicalConceptSurrogate classes which identifies the set of biomedical concept surrogates associated with the activity.
A USDM relationship between the Activity and BiomedicalConcept classes which identifies the set of biomedical concepts associated with the activity.
A USDM relationship within the Activity class which identifies the set of child activities associated with an activity.
A USDM relationship between the Activity and Procedure classes which identifies the set of defined procedures associated with the activity.
A USDM relationship within the Activity class which identifies the activity that follows the current activity in the display order.
A brief written record relevant to the activity.
A USDM relationship within the Activity class which identifies the activity that precedes the current activity in the display order.
A USDM relationship between the Activity and ScheduleTimeline classes which provides the details associated with an instance of the scheduled timeline related to the activity.
A sovereign nation occupying a distinct territory and ruled by an autonomous government.
Y (Point out to ISO 3166-1 Alpha-3 Country code)
The physical form in which formulated ingredient(s) are presented in the administrable product.
A USDM relationship between the AdministrableProduct and AdministrableProductIdentifier classes which provides the set of identifiers related to the administrable product.
A USDM relationship between the AdministrableProduct and Ingredient classes which provides the set of ingredients related to the administrable product.
A brief written record relevant to the administrable product.
The pharmacological class of the administrable product.
Administrable Product Pharmacologic Class
Y (Points to external codelists such as UNII, MED-RT)
An indication as to whether the administrable product is an investigational medicinal product or an auxiliary medicinal product.
Administrable Product Product Designation
A USDM relationship between the AdministrableProduct and AdministrableProductProperty classes which provides the set of properties related to the administrable product.
An indication as to whether the administrable product is obtained from a local or central source.
The numeric value associated with an administrable product property.
Administrable Product Property Quantity Value
A characterization or classification of the administrable product property.
A USDM relationship between the Administration and AdministrableProductDefinition classes which identifies the administrable product associated with the administration of the product, agent, or therapy.
The value representing the amount of an agent given to an individual at one time.
The amount of time elapsed during the administration of an agent.
The number of doses administered per a specific interval.
A USDM relationship between the Administration and MedicalDevice classes which identifies the medical device associated with an instance of product, agent, or therapy administration.
A brief written record relevant to the administration of the product, agent, or therapy.
The pathway by which a substance is administered in order to reach the site of action in the body.
A combination of symbols that is used to represent the standard code.
Alternative combinations of symbols used to represent aliases or alternatives to the standard code.
A brief written record relevant to the analysis population.
A USDM relationship between the AnalysisPopulation and PopulationDefinition classes which identifies the population definition of which the analysis population is a subset.
A USDM relationship between the AssignedPerson and Organization classes that identifies that organization to which the assigned person belongs.
A word or group of words indicating the identity of an assigned person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.
A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept.
A brief written record relevant to the biomedical concept.
A USDM relationship between the BiomedicalConcept and BiomedicalConceptProperty classes which identifies the set of properties associated with the biomedical concept.
A USDM relationship within the BiomedicalConceptCategory class which identifies the set of child categories of a biomedical concept.
A symbol or combination of symbols which is assigned to the biomedical concept category.
A USDM relationship between the BiomedicalConceptCategory and BiomedicalConcept classes which identifies the set of biomedical concept members associated with the biomedical concept category.
A brief written record relevant to the biomedical concept category.
A concept unique identifier assigned to a biomedical concept property that points to the meaning of that biomedical concept property.
Biomedical Concept Property Concept Code
A brief written record relevant to the biomedical concept property.
A USDM relationship between the BiomedicalConceptProperty and ResponseCode classes which identifies the set of response codes associated with the biomedical concept property.
A brief written record relevant to the biomedical concept surrogate.
A symbol or combination of symbols which is assigned to the comment annotation.
A USDM relationship between the Condition and the Activity, Procedure, BiomedicalConcept, BiomedicalConceptSurrogate, or BiomedicalConceptCategory classes which identifies the procedure, activity, biomedical concept, biomedical concept surrogate, or biomedical concept category that applies to the condition.
A USDM relationship between the Condition and the ScheduledActivityInstance or Activity classes which identifies the scheduled activity instance or activity to which the condition belongs.
A USDM relationship between the ConditionAssignment and ScheduledInstance classes which identifies the scheduled instance associated with the condition assignment.
A USDM relationship between the DocumentContentReference and StudyDefinitionDocument classes which identifies the study definition document to which the document content reference applies.
The value representing the amount of time over which the event occurs.
A classification of the inclusion exclusion criterion.
A USDM relationship between the EligibilityCriterion and EligibilityCriterionItem classes which identifies the item belonging to the eligibility criterion.
A USDM relationship within the EligibilityCriterion class which identifies the eligibility criterion that follows the current eligibility criterion in the display order.
A brief written record relevant to the eligibility criterion.
A USDM relationship within the EligibilityCriterion class which identifies the eligibility criterion that precedes the current eligibility criterion in the display order.
The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device).
The environment/setting where the event, intervention, or finding occurred.
A USDM relationship within the Encounter class which identifies the encounter that chronologically follows the current encounter.
A brief written record relevant to the study encounter.
A USDM relationship within the Encounter class which identifies the encounter that chronologically precedes the current encounter.
A USDM relationship between the Encounter and Timing classes which provides information related to the scheduled timing of an encounter.
A USDM relationship between the Encounter and TransitionRule classes which provides the details associated with a transition rule used to trigger the end of an encounter.
A USDM relationship between the Encounter and TransitionRule classes which provides the details associated with a transition rule used to trigger the start of an encounter.
A characterization or classification of the study encounter.
A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints.
A USDM relationship between the Estimand and AnalysisPopulation classes which provides the details associated with an instance of the analysis population used to partially define a study estimand.
A USDM relationship between the Estimand and IntercurrentEvent classes which identifies the set of intercurrent events associated with a study estimand.
A USDM relationship between the Estimand and StudyIntervention classes which identifies the set of study interventions associated with the Estimand.
A brief written record relevant to the study estimand.
A USDM relationship between the Estimand and Endpoint classes which provides the details associated with an instance of the variable of interest within a study endpoint used to partially define a study estimand.
A symbol or combination of symbols which is assigned to the geographic scope.
Y (Point out to external dictionaries: Standard code is ISO-3166; Alias codes drawn from GENC, UN Region Codes, etc.)
A characterization or classification of the geographic scope.
A USDM relationship between the GovernanceDate and GeographicScope classes which identifies the set of geographic scopes associated with the governance date.
A characterization or classification of the study governance date.
A USDM relationship between the AdministrableProductIdentifier and Organization class which provides the details associated with which provides the details associated with each organization that has assigned the administrable product identifier.
A short sequence of characters that represents the disease/condition indication.
Y (Point out to multiple Biomedical coding dictionaries such as SNOMEDCT (for FDA), MedDRA, NCIt, ICD's, etc.)
A brief written record relevant to the disease/condition indication.
The intended use of the ingredient within the context of the compounded substance or mixture.
Y (Point to FHIR value set: Ingredient Role)
A USDM relationship between the Ingredient and Substance classes that identifies the substance associated with the ingredient.
The type of experimental design used to describe the level of awareness of the study subjects and/ or study personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
The planned purpose of the therapy, device, or agent under study in the clinical trial.
The general design of the strategy for assigning interventions to subjects in a clinical study. (clinicaltrials.gov)
The nature of the interventional study for which information is being collected.
A USDM relationship between the MedicalDevice and AdministrableProduct classes which identifies the administrable product that is an integral component of the medical device.
A USDM relationship between the MedicalDevice and MedicalDeviceIdentifier classes which provides the set of identifiers related to the medical device.
A brief written record relevant to the medical device.
An indication as to whether the medical device is obtained from a local or central source.
A characterization or classification of the medical device identifier.
A USDM relationship within the NarrativeContent class which identifies the set of child content associated with an instance of narrative content.
A USDM relationship between the NarrativeContent and NarrativeContentItem classes which identifies the content item associated with the narrative content.
A USDM relationship within the NarrativeContent class which identifies the narrative content that follows the current narrative content in the display order.
A USDM relationship within the NarrativeContent class which identifies the narrative content that precedes the current narrative content in the display order.
A USDM relationship between the Objective and Endpoint classes which identifies the set of endpoints associated with the study objective.
A characterization or classification of the study objective that determines its category of importance relative to other study objectives.
The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)
The sampling method used to assign study participants into groups or cohorts within an observational study.
The nature of the observational study for which information is being collected.
The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov)
A USDM relationship between the Organization and Address classes which provides the legal address for an organization.
A USDM relationship between the Organization and StudySite classes which identifies the set of study sites managed by the organization.
A characterization or classification of the formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.
A USDM relationship between the StudyCohort and EligibilityCriterion classes which identifies the set of eligibility criteria associated with the study cohort.
A brief written record relevant to the study cohort.
The anticipated age of subjects within the study cohort.
The value representing the planned number of subjects that must complete the study in order to meet the objectives and endpoints of the study, within the study cohort.
The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort.
The protocol-defined sex within the study cohort.
A symbol or combination of symbols which is assigned to medical procedure.
Y (Point out to external dictionary like CPT, MedDRA, SNOMEDCT, etc.)
A brief written record relevant to the procedure.
A USDM relationship between the Procedure and StudyInterventionclasses which provides the details associated with an instance of an intervention performed during the conduct of a procedure.
A USDM relationship between the ProductOrganizationRole and either the AdministrableProduct or MedicalDevice class that identifies the administrable product or medical device to which the product organization role applies.
A symbol or combination of symbols which is assigned to the product organization role.
A USDM relationship between the ProductOrganizationRole and Organization classes which identifies the organization associated with the product organization role.
The type of unit of measure being used to express a quantity.
The largest value in quantity or degree in a set of values.
The smallest value in quantity or degree in a set of values.
A characterization or classification of the reference identifier.
A USDM relationship between the ScheduleTimeline and ScheduledInstance classes which defines the entry into a scheduled instance (e.g., scheduled activity instances or scheduled decision instances) for a timeline.
A USDM relationship between the ScheduleTimeline and ScheduleTimelineExit classes which identifies the set of exits from the scheduled timeline.
A USDM relationship between the ScheduleTimeline and ScheduledInstance classes which identifies the set of scheduled instances (e.g., scheduled activity instances or scheduled decision instances) associated with the scheduled timeline.
The period of time over which the scheduled timeline is intended to take place.
A USDM relationship between the ScheduleTimeline and Timing classes which identifies the set of timings associated with the scheduled timeline.
A USDM relationship between the ScheduledActivityInstance and Activity classes which identifies the set of activities associated with a scheduled activity instance.
A USDM relationship between the ScheduledActivityInstance and Encounter classes which defines the subject encounter associated with the ScheduleActivityInstance.
A USDM relationship between the ScheduledActivityInstance and ScheduleTimelineExit classes which provides the details associated with the exit from a timeline related to a scheduled activity instance.
A USDM relationship between the ScheduledActivityInstance and ScheduleTimeline classes which provides the details associated with an instance of a scheduled timeline related to a scheduled activity instance.
A USDM relationship between the ScheduledDecisionInstance and ConditionAssignment classes which identifies the set of condition assignments associated with a scheduled decision instance.
A USDM relationship within the ScheduledActivityInstance class which identifies the default condition within a scheduled activity instance.
A USDM relationship between the ScheduledActivityInstance and StudyEpoch classes which identifies the study epoch associated with a scheduled activity instance.
A USDM relationship between the Study and StudyDefinitionDocument classes signifying that the study is documented in a study definition document.
A USDM relationship between the Study and StudyVersion classes which identifies the set of versions associated with the study.
A USDM relationship between the StudyAmendment and StudyChange classes which identifies the set of changes associated with the study amendment.
A USDM relationship between the StudyAmendment and GovernanceDate classes which provides the set of governance dates associated with the study amendment.
A USDM relationship between the StudyAmendment and SubjectEnrollment classes which provides the set of subject enrollments associated with the study amendment.
A USDM relationship between the StudyAmendment and GeographicScope classes which identifies the set of geographic scopes associated with the study amendment.
A USDM relationship between the StudyAmendment and StudyAmendmentImpact classes which identifies the set of impacts that the study amendment has on the study or study subjects.
A brief written record relevant to the study amendment.
A USDM relationship within the StudyAmendment class which identifies the study amendment that chronologically precedes the current study amendment.
A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the primary reason for issuing the study amendment.
A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the set of secondary reasons for issuing the study amendment.
A brief written record relevant to the study amendment impact.
A characterization or classification of the study amendment impact.
A symbol or combination of symbols which is assigned to the study amendment reason.
A characterization or classification of the study arm with respect to where the study arm data originates.
A brief written record relevant to the study arm.
A USDM relationship between the StudyArm and PopulationDefinition classes which identifies the set of populations associated with the study arm.
A characterization or classification of the study arm.
Y (Protocol Terminology Codelist C174222)
A USDM relationship between the StudyCell and StudyArm classes which identifies the study arm associated with a study cell.
A USDM relationship between the StudyCell and StudyElement classes which identifies the set of study elements associated with the study cell.
A USDM relationship between the StudyCell and StudyEpoch classes which identifies the study epoch associated with a study cell.
A USDM relationship between the StudyChange and DocumentContentReference class which provides the set of changed document sections related to the study change.
A USDM relationship between the StudyCohort and Characteristic classes which identifies the set of subject characteristics associated with the study cohort.
A USDM relationship between the StudyCohort and Indication classes which identifies the set of indications associated with the study cohort.
A USDM relationship within the StudyDefinitionDocument class which identifies the set of child documents of a study definition document.
The language in which the study definition document is written.
Y (Point out to ISO 639 language value list)
A brief written record relevant to the study definition document.
A characterization or classification of the study definition document.
A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion classes which identifies the set of versions associated with the study definition document.
A USDM relationship between the StudyDefinitionDocumentVersion and NarrativeContent classes which identifies the set of narrative content associated with the version of the study definition document.
A USDM relationship between the StudyDefinitionDocumentVersion and GovernanceDate classes which provides the set of governance dates associated with the study definition document version.
A brief written record relevant to the study definition document version.
A condition of the study definition document at a point in time with respect to its state of readiness for implementation.
A USDM relationship between the InterventionalStudyDesign and Activity classes which identifies the set of activities associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyArm classes which identifies the set of study arms associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention classes which identifies the status of biospecimen retentions related to the interventional study design.
The distinguishing qualities or prominent aspects of an interventional study design.
Interventional Study Design Characteristics
A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion classes which identifies the version of the study definition documents associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyElement classes which identifies the set of study elements associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion classes which identifies the set of eligibility criterion associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and Encounter classes which identifies the set of encounters associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyEpoch classes which identifies the set of study epochs associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and Estimand classes which identifies the set of estimands associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and Indication classes which identifies the set of indications associated with the interventional study design.
A brief written record relevant to the interventional study design.
A USDM relationship between the InterventionalStudyDesign and Objective classes which identifies the set of objectives associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation classes which identifies the population associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline classes which identifies the set of scheduled timelines associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyCell classes which identifies the set of study cells associated with the interventional study design.
A USDM relationship between the InterventionalStudyDesign and StudyIntervention classes which identifies the set of study interventions associated with interventional study design.
The study phase associated with the interventional study design.
The study type associated with the interventional study design.
A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the interventional study design.
Interventional Study Design Therapeutic Areas
A USDM relationship between the StudyDesignPopulation and StudyCohort classes which identifies the set of study cohorts associated with the study design population.
A brief written record relevant to the study element.
A USDM relationship between the StudyElement and StudyIntervention classes which identifies the set of study interventions associated with the study element.
A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the end of a study element.
A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the start of a study element.
A USDM relationship within the StudyEpoch class which identifies the study epoch that chronologically follows the current study epoch.
A brief written record relevant to the study epoch.
A USDM relationship within the StudyEpoch class which identifies the study epoch that chronologically precedes the current study epoch.
A characterization or classification of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
A USDM relationship between the StudyIntervention and AgentAdministration classes which identifies the set of agent administrations associated with the study intervention.
A symbol or combination of symbols which is assigned to the study intervention.
Y (Point out to multiple Biomedical coding dictionaries such as WHODrug, ATC, UNII, etc.)
The value representing the minimum amount of time required to meet the criteria for response to study intervention.
Study Intervention Minimum Response Duration
A brief written record relevant to the study intervention.
The intended use of the trial intervention within the context of the study design.
The kind of product or procedure studied in a trial.
A USDM relationship between the StudyRole and either StudyVersion or StudyDesign classes that identifies the study version or study design to which the study role applies.
A USDM relationship between the StudyRole and AssignedPerson classes that identifies the set of individuals that are assigned to fill a particular role within the study.
A symbol or combination of symbols which is assigned to the study role.
A USDM relationship between the StudyRole and Masking classes which describes the masking associated with the study role.
A brief written record relevant to the study role.
A USDM relationship between the StudyRole and Organization classes which identifies the set of organizations associated with the study role.
The country in which the study site is located.
A characterization or classification of the study title.
A USDM relationship between the StudyVersion and Abbreviation classes which provides the set of abbreviations associated with the study version.
A USDM relationship between the StudyVersion and StudyAmendment classes which identifies the set of study amendments associated with the study version.
A therapeutic area classification based on the structure and operations of the business unit.
A USDM relationship between the StudyVersion and GovernanceDate classes which provides the set of governance dates associated with the study version.
A USDM relationship between the StudyVersion and StudyDefinitionDocumentVersion classes which identifies the version of the study definition document associated with the study version.
A brief written record relevant to the study version.
A USDM relationship between the StudyVersion and ReferenceIdentifier classes which identifies the set of reference identifiers associated with the study version.
A USDM relationship between the StudyVersion and StudyDesign classes which identifies the set of study designs associated with the study version.
A USDM relationship between the StudyVersion and StudyIdentifier classes which identifies the set of study identifiers associated with the study version.
A USDM relationship between the StudyVersion and StudyTitle classes which identifies the set of study titles associated with the study version.
A USDM relationship between the SubjectEnrollment and GeographicScope classes which identifies the geographic scope to which the subject enrollment applies.
A USDM relationship between the SubjectEnrollment and StudyCohort classes which identifies the study cohort to which the subject enrollment applies.
A USDM relationship between the SubjectEnrollment and StudySite classes which identifies the study site to which the subject enrollment applies.
The value representing the number of individuals enrolled in a study.
A symbol or combination of symbols which is assigned to the substance.
A USDM relationship within the Substance class that identifies the association between two substances, one of which is used as a reference for the other.
A USDM relationship between the Substance and Strength class which provides the values of the strengths of the substance.
A USDM relationship between the Characteristic and SyntaxTemplateDictionary classes which provides the set of dictionary entries related to characteristics.
A brief written record relevant to the characteristic.
A USDM relationship between the SyntaxTemplateDictionary and ParameterMap classes which identifies the set of parameter maps (parameter map entries) associated with a syntax template dictionary.
A USDM relationship between the Timing and ScheduledInstance classes which identifies the scheduled instance (e.g., scheduled activity instances or scheduled decision instances) to which the timing applies.
The name of the reference event used to define the temporal relationship with another event.
A USDM relationship between the Timing and ScheduledInstance classes which identifies the scheduled instance (e.g., scheduled activity instances or scheduled decision instances) to which the timing is relative to.
A characterization or classification of the chronological relationship between temporal events.
The literal value of an instance of unstructured text that is used as the abbreviation.
The full literal representation of the abbreviation.
A narrative representation of the study activity.
The short descriptive designation for the study activity.
The literal identifier (i.e., distinctive designation) of the study activity.
A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address.
An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic.
The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located.
An alphanumeric code assigned to a mail delivery area.
A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government.
A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization.
A narrative representation of the administrable product.
Administrable Product Definition Description
The short descriptive designation for the administrable product.
The literal identifier (i.e., distinctive designation) of the administrable product.
The literal identifier (i.e., distinctive designation) of the administrable product property.
An instance of structured text that represents the administrable product property.
A narrative representation for the administration of a product, agent, or therapy.
The short descriptive designation for the administration of a product, agent, or therapy.
The literal identifier (i.e., distinctive designation) for the administration of a product, agent, or therapy.
A narrative representation of the analysis population.
The short descriptive designation for the analysis population.
The literal identifier (i.e., distinctive designation) of the analysis population.
An instance of unstructured text that represents the analysis population.
A narrative representation of the assigned person.
An identifying designation related to the assigned person's occupation.
The short descriptive designation for the assigned person.
The literal identifier (i.e., distinctive designation) of the assigned person.
The short descriptive designation for the biomedical concept.
The literal identifier (i.e., distinctive designation) of the biomedical concept.
A citation to an authoritative source for a biomedical concept.
A word or an expression that serves as a figurative, symbolic, or exact substitute for a biomedical concept, and which has the same meaning.
A narrative representation of the biomedical concept category.
The short descriptive designation for the biomedical concept category.
The literal identifier (i.e., distinctive designation) of the biomedical concept category.
The structural format of the biomedical concept property response value. The datatype is carried in the attribute and influences the set of allowable values the attribute may assume. (After HL7)
Biomedical Concept Property Response Data Type
An indication as to whether the biomedical concept property is activated for use within a given usage context for a biomedical concept.
Biomedical Concept Property Enabled Indicator
An indication as to whether the biomedical concept property is required.
Biomedical Concept Property Required Indicator
The short descriptive designation for the biomedical concept property.
The literal identifier (i.e., distinctive designation) of the biomedical concept property.
A narrative representation of the biomedical concept surrogate.
Biomedical Concept Surrogate Description
The short descriptive designation for the biomedical concept surrogate.
The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate.
A citation to an authoritative source for a biomedical concept surrogate.
A narrative representation of the biospecimen retention.
An indication as to whether retained biospecimens contain DNA.
Biospecimen Retention Includes DNA Indicator
An indication as to whether biospecimens were retained.
The short descriptive designation for the biospecimen retention.
The literal identifier (i.e., distinctive designation) of the biospecimen retention.
The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes.
Standardized or dictionary-derived human readable text associated with a code.
An instance of unstructured text that represents the comment annotation.
An assumption on which rests the validity or effect of something else.
The numeric identifier of a particular section for the document content reference.
Document Content Reference Section Number
An identifying designation for a particular section for the document content reference.
Document Content Reference Section Title
An indication as to whether the event duration is planned to vary within and/or across subjects.
The explanation for why the event duration will vary within and/or across subjects.
An instance of unstructured text that represents the event duration.
A narrative representation of the study eligibility criterion.
A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion.
The short descriptive designation for the study eligibility criterion.
The literal identifier (i.e., distinctive designation) of the study eligibility criterion.
A narrative representation of the protocol-defined study encounter.
The short descriptive designation for the study encounter.
The literal identifier (i.e., distinctive designation) for a protocol-defined study encounter.
The textual representation of the study endpoint purpose.
A narrative representation of the estimand.
The short descriptive designation for the estimand.
The literal identifier (i.e., distinctive designation) of the estimand.
A synopsis of the clinical endpoint of interest within the analysis target study population.
The information contained in the date field.
A narrative representation of the study governance date.
The short descriptive designation for the study governance date.
The literal identifier (i.e., distinctive designation) of the study governance date
An instance of structured text that represents the administrable product.
A narrative representation of the condition, disease or disorder that the clinical trial is intended to investigate or address.
Disease/Condition Indication Description
An indication as to whether the disease/condition indication under study is considered a rare disease.
Disease/Condition Indication Is Rare Disease Indicator
The short descriptive designation for the disease/condition indication.
The literal identifier (i.e., distinctive designation) of the disease/condition indication.
A textual description of the planned strategy to manage and/or mitigate intercurrent events.
An indication as to whether the study role is masked.
An instance of unstructured text that represents how the masking is performed and maintained.
A narrative representation of the medical device.
A form or variant of hardware; one of a sequence of copies of the physical components from which a computer is constructed, each incorporating new modifications.
The short descriptive designation for the medical device.
The literal identifier (i.e., distinctive designation) of the medical device.
A form or variant of software; one of a sequence of copies of a software program, each incorporating new modifications. (NCI)
An indication as to whether the section number is to be displayed in the document containing narrative content.
Narrative Content Section Number Display Indicator
An indication as to whether the section title is to be displayed in the document containing narrative content.
Narrative Content Section Title Display Indicator
The literal identifier (i.e., distinctive designation) of the narrative content.
The numeric identifier assigned to a particular document section containing narrative content.
An identifying designation for the document section containing narrative content.
The literal identifier (i.e., distinctive designation) of the narrative content item.
An instance of unstructured text that represents the narrative content item.
A unique symbol that establishes identity of the organization. (BRIDG)
The name of the organization that provides the identifier for the entity.
The short descriptive designation for the organization.
The literal identifier (i.e., distinctive designation) of the organization.
The reference for a tag used in programming languages, such as a markup language (e.g., HTML, XML), to store attributes and elements.
Character strings bounded by angle brackets that act as containers for programming language elements.
A word or group of words indicating a person's last (family) name.
A word or group of words indicating a person's first (personal or given) name; the name that precedes the surname.
An affix occurring at the start of the person name string, usually denoting a title or honorific.
An affix occurring at the end of the person name, usually denoting educational or professional degrees and certifications, and/or filial rank.
An instance of structured text that represents the person's full name.
A narrative representation of the study cohort.
An indication as to whether the study cohort includes healthy subjects, that is, subjects without the disease or condition under study.
Study Cohort Includes Healthy Subjects Indicator
The short descriptive designation for the study cohort.
The literal identifier (i.e., distinctive designation) of the study cohort.
A narrative representation of the procedure.
The short descriptive designation for the procedure.
The literal identifier (i.e., distinctive designation) of the procedure.
A characterization or classification of the study procedure.
A narrative representation of the product organization role.
The short descriptive designation for the product organization role.
The literal identifier (i.e., distinctive designation) of the product organization role.
A numerical quantity measured or assigned or computed.
An indication as to whether the value range is almost, but not quite, exact.
An indication as to whether the response code is activated for use within a given usage context.
The short descriptive designation for the response code.
The literal identifier (i.e., distinctive designation) of the response code.
A narrative representation of the schedule timeline.
A logical evaluation on which rests the validity of entry into a schedule timeline.
The short descriptive designation for the schedule timeline.
An indication as to whether the timeline or timeline component is part of the central or principal timeline.
The literal identifier (i.e., distinctive designation) of the schedule timeline.
A narrative representation of the scheduled activity instance.
The short descriptive designation for the scheduled activity instance.
The literal identifier (i.e., distinctive designation) of the scheduled activity instance.
A narrative representation of the substance strength.
The short descriptive designation for the substance strength.
The literal identifier (i.e., distinctive designation) of the substance strength.
A narrative representation of the clinical study.
The short descriptive designation for the clinical study.
The literal identifier (i.e., distinctive designation) of the clinical study.
A narrative representation of the study amendment.
The short descriptive designation for the study amendment.
The literal identifier (i.e., distinctive designation) of the study amendment.
A string of numerals that uniquely identifies a protocol amendment.
A short narrative representation describing the changes introduced in the current version of the protocol.
An indication as to whether the study amendment's impact on the study is substantial.
Study Amendment Impact Substantial Indicator
An instance of unstructured text that represents the study amendment impact.
The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified.
The textual representation of the study arm data origin.
A narrative representation of the study arm.
The short descriptive designation for the study arm.
The literal identifier (i.e., distinctive designation) of the study arm.
A narrative representation of the study change.
The short descriptive designation for the study change.
The literal identifier (i.e., distinctive designation) of the study change.
An explanation as to the logical reasons for why a study change has occurred.
A short narrative representation describing the changes introduced in the current version of the study.
A narrative representation of the study definition document.
The short descriptive designation for the study definition document.
The literal identifier (i.e., distinctive designation) of the study definition document.
The literal identifier (i.e., distinctive designation) of the study definition document template.
A sequence of characters used to identify the version of the study definition document.
Study Definition Document Version Identifier
A narrative representation of the interventional study design.
The short descriptive designation for the interventional study design.
The literal identifier (i.e., distinctive designation) of the interventional study design.
Reason(s) for choosing the interventional study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.
A narrative representation of the study design element.
The short descriptive designation for the study design element.
The literal identifier (i.e., distinctive designation) of the study design element.
A narrative representation of the study epoch.
The short descriptive designation for the study epoch.
The literal identifier (i.e., distinctive designation) of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
A narrative representation of the study intervention.
The short descriptive designation for the study intervention.
The literal identifier (i.e., distinctive designation) of the study intervention.
A narrative representation of the study role.
The short descriptive designation for the study role.
The literal identifier (i.e., distinctive designation) of the study role.
A narrative representation of the study site.
The short descriptive designation for the study site.
The literal identifier (i.e., distinctive designation) of the study site.
An instance of unstructured text that represents the study title.
A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study.
A sequence of characters used to identify, name, or characterize the study version.
A narrative representation of the subject enrollment.
The short descriptive designation for the subject enrollment..
The literal identifier (i.e., distinctive designation) of the subject enrollment.
A narrative representation of the substance.
The short descriptive designation for the substance.
The literal identifier (i.e., distinctive designation) of the substance.
A narrative representation of the characteristic.
The short descriptive designation for the characteristic.
The literal identifier (i.e., distinctive designation) of the characteristic.
An instance of structured text that represents the characteristic.
A narrative representation of the syntax template dictionary.
The short descriptive designation for the syntax template dictionary.
The literal identifier (i.e., distinctive designation) of the syntax template dictionary.
A narrative representation of the chronological relationship between temporal events.
The short descriptive designation for the timing.
The literal identifier (i.e., distinctive designation) of the timing.
The temporal value of the chronological relationship between temporal events.
The short descriptive designation for the timing value.
The short descriptive designation for a time period, or other type of interval, during which a temporal event may be achieved, obtained, or observed.
The earliest chronological value of an allowable period of time during which a temporal event takes place.
The latest chronological value of an allowable period of time during which a temporal event takes place.
A narrative representation of the transition rule.
The short descriptive designation for the transition rule.
The literal identifier (i.e., distinctive designation) of the transition rule.
An instance of unstructured text that represents the transition rule.
A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. (CDISC Glossary)
An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study.
A standardized representation of the location of a person, business, building, or organization. (NCI)
Any study product that is formulated and presented in the form that is suitable for administration to a study participant.
A sequence of characters used to identify, name, or characterize the administrable product.
A characteristic from a set of characteristics used to define an administrable product.
The act of dispensing, applying, or tendering a product, agent, or therapy.
An alternative symbol or combination of symbols which is assigned to the members of a collection.
A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum)
An individual person who is allotted or appointed to a particular role, function, or other entity.
A unit of biomedical knowledge created from a unique combination of characteristics that include implementation details like variables and terminologies, used as building blocks for standardized, hierarchically structured clinical research information.
A grouping of biomedical concepts based on some commonality or by user defined characteristics.
A characteristic from a set of characteristics used to define a biomedical concept.
A concept that substitutes for a standard biomedical concept from the designated source.
The continued possession, cataloging, and storage of collected biological specimens beyond their initial use.
The distinguishing qualities or prominent aspects of an entity.
A symbol or combination of symbols which is assigned to the members of a collection.
An explanatory or critical comment, or other in-context information (e.g., pattern, motif, link), that has been associated with data or other types of information.
An allotting or appointment to a condition or set of conditions that are to be met in order to make a logical decision.
A citation pointing to the location of specific content within a document.
The length of time during which something continues.
Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria.
An individual item within the container that holds an instance of an eligibility criterion.
Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place.
A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary)
A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared. (ICH E9 R1 Addendum)
The extent or range related to the physical location of an entity.
Any of the dates associated with event milestones within a clinical study's oversight and management framework.
One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing.
The disease or condition the intervention will diagnose, treat, prevent, cure, or mitigate.
Any component that constitutes a part of a compounded substance or mixture.
An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. (ICH E9 Addendum on Estimands)
The strategy that specifies the structure of an interventional trial in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.
The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from a comparator. (CDISC Glossary)
Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]
A sequence of characters used to identify, name, or characterize the medical device.
The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.
An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.
The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.
The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.
A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose. (BRIDG)
The paired name and value for a given parameter.
A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.
A concise explanation of the meaning of a population.
Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care.
A designation that identifies the function of an organization within the context of the product.
How much there is of something that can be measured; the total amount or number.
The total amount (number), or the limits (minimum and maximum) of a variation.
An expression that defines the lower and upper limits of a variation.
A sequence of characters used to identify, name, or characterize the reference.
A symbol or combination of symbols representing the response to the question.
A chronological schedule of planned temporal events.
To go out of or leave the schedule timeline.
A scheduled occurrence of an activity event.
A scheduled occurrence of a decision event.
A scheduled occurrence of a temporal event.
The content of an substance expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form of the product.
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary)
A written description of a change(s) to, or formal clarification of, a study.
The effect or consequence of an amendment on some aspect of the study.
The rationale for the change(s) to, or formal clarification of, a protocol.
A planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path.
A partitioning of a study arm into individual pieces, which are associated with an epoch and any number of sequential elements within that epoch.
The act of alteration or modification to a study.
A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study.
Any physical or electronic document that is related to defining a study or part of a study.
A representation of a particular edition or snapshot of the study definition document as it exists at a particular point in time.
A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach.
The population within the general population to which the study results can be generalized.
A basic building block for time within a clinical study comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
A named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
A sequence of characters used to identify, name, or characterize the study.
Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial.
A designation that identifies the function of study personnel or an organization within the context of the study.
The location at which a study investigator conducts study activities.
The sponsor-defined name of the clinical study.
A plan at a particular point in time for a study.
The act of enrolling subjects into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. (CDISC Glossary)
Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences.
A reference source that provides a listing of valid parameter names and values used in syntax template text strings.
The chronological relationship between temporal events.
A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan.