USDM v4 LinkML
LinkML representation generated from the CDISC DDF-RA USDM v4 dataStructure.yml model.
URI: https://example.org/usdm/v4/linkml
Name: usdm_v4
Classes
| Class | Description |
|---|---|
| Abbreviation | 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) |
| Activity | 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. |
| Address | A standardized representation of the location of a person, business, building, or organization. (NCI) |
| AdministrableProduct | Any study product that is formulated and presented in the form that is suitable for administration to a study participant. |
| AdministrableProductProperty | A characteristic from a set of characteristics used to define an administrable product. |
| Administration | The act of dispensing, applying, or tendering a product, agent, or therapy. |
| AliasCode | An alternative symbol or combination of symbols which is assigned to the members of a collection. |
| AnalysisPopulation | 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) |
| AssignedPerson | An individual person who is allotted or appointed to a particular role, function, or other entity. |
| BiomedicalConcept | 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. |
| BiomedicalConceptCategory | A grouping of biomedical concepts based on some commonality or by user defined characteristics. |
| BiomedicalConceptProperty | A characteristic from a set of characteristics used to define a biomedical concept. |
| BiomedicalConceptSurrogate | A concept that substitutes for a standard biomedical concept from the designated source. |
| BiospecimenRetention | The continued possession, cataloging, and storage of collected biological specimens beyond their initial use. |
| Code | A symbol or combination of symbols which is assigned to the members of a collection. |
| CommentAnnotation | 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. |
| ConditionAssignment | An allotting or appointment to a condition or set of conditions that are to be met in order to make a logical decision. |
| DocumentContentReference | A citation pointing to the location of specific content within a document. |
| Duration | The length of time during which something continues. |
| EligibilityCriterion | 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. |
| Encounter | Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place. |
| Estimand | 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) |
| ExtensionAttribute | |
| ExtensionClass | |
| GeographicScope | The extent or range related to the physical location of an entity. |
| GovernanceDate | Any of the dates associated with event milestones within a clinical study's oversight and management framework. |
| Identifier | One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. |
| AdministrableProductIdentifier | A sequence of characters used to identify, name, or characterize the administrable product. |
| MedicalDeviceIdentifier | A sequence of characters used to identify, name, or characterize the medical device. |
| ReferenceIdentifier | A sequence of characters used to identify, name, or characterize the reference. |
| StudyIdentifier | A sequence of characters used to identify, name, or characterize the study. |
| Indication | The disease or condition the intervention will diagnose, treat, prevent, cure, or mitigate. |
| Ingredient | Any component that constitutes a part of a compounded substance or mixture. |
| Masking | The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from a comparator. (CDISC Glossary) |
| MedicalDevice | 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] |
| NarrativeContent | The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. |
| NarrativeContentItem | An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. |
| Organization | 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) |
| ParameterMap | The paired name and value for a given parameter. |
| PersonName | 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. |
| PopulationDefinition | A concise explanation of the meaning of a population. |
| StudyCohort | A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study. |
| StudyDesignPopulation | The population within the general population to which the study results can be generalized. |
| Procedure | Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care. |
| ProductOrganizationRole | A designation that identifies the function of an organization within the context of the product. |
| QuantityRange | The total amount (number), or the limits (minimum and maximum) of a variation. |
| Quantity | How much there is of something that can be measured; the total amount or number. |
| Range | An expression that defines the lower and upper limits of a variation. |
| ResponseCode | A symbol or combination of symbols representing the response to the question. |
| ScheduledInstance | A scheduled occurrence of a temporal event. |
| ScheduledActivityInstance | A scheduled occurrence of an activity event. |
| ScheduledDecisionInstance | A scheduled occurrence of a decision event. |
| ScheduleTimeline | A chronological schedule of planned temporal events. |
| ScheduleTimelineExit | To go out of or leave the schedule timeline. |
| Strength | 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. |
| Study | 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) |
| StudyAmendment | A written description of a change(s) to, or formal clarification of, a study. |
| StudyAmendmentImpact | The effect or consequence of an amendment on some aspect of the study. |
| StudyAmendmentReason | The rationale for the change(s) to, or formal clarification of, a protocol. |
| StudyArm | 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. |
| StudyCell | A partitioning of a study arm into individual pieces, which are associated with an epoch and any number of sequential elements within that epoch. |
| StudyChange | The act of alteration or modification to a study. |
| StudyDefinitionDocument | Any physical or electronic document that is related to defining a study or part of a study. |
| StudyDefinitionDocumentVersion | A representation of a particular edition or snapshot of the study definition document as it exists at a particular point in time. |
| StudyDesign | 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. |
| InterventionalStudyDesign | 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. |
| ObservationalStudyDesign | 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. |
| StudyElement | 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. |
| StudyEpoch | 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. |
| StudyIntervention | Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial. |
| StudyRole | A designation that identifies the function of study personnel or an organization within the context of the study. |
| StudySite | The location at which a study investigator conducts study activities. |
| StudyTitle | The sponsor-defined name of the clinical study. |
| StudyVersion | A plan at a particular point in time for a study. |
| SubjectEnrollment | 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) |
| Substance | Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical. |
| SyntaxTemplate | A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences. |
| Characteristic | The distinguishing qualities or prominent aspects of an entity. |
| Condition | A state of being. |
| EligibilityCriterionItem | An individual item within the container that holds an instance of an eligibility criterion. |
| Endpoint | 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) |
| IntercurrentEvent | 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) |
| Objective | The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. |
| SyntaxTemplateDictionary | A reference source that provides a listing of valid parameter names and values used in syntax template text strings. |
| Timing | The chronological relationship between temporal events. |
| TransitionRule | 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. |
Slots
| Slot | Description |
|---|---|
| abbreviatedText | The literal value of an instance of unstructured text that is used as the abbreviation. |
| abbreviations | A USDM relationship between the StudyVersion and Abbreviation classes which provides the set of abbreviations associated with the study version. |
| activities | A USDM relationship between the InterventionalStudyDesign and Activity classes which identifies the set of activities associated with the interventional study design. |
| activityIds | A USDM relationship between the ScheduledActivityInstance and Activity classes which identifies the set of activities associated with a scheduled activity instance. |
| administrableDoseForm | The physical form in which formulated ingredient(s) are presented in the administrable product. |
| administrableProductId | A USDM relationship between the Administration and AdministrableProductDefinition classes which identifies the administrable product associated with the administration of the product, agent, or therapy. |
| administrableProducts | |
| administrations | A USDM relationship between the StudyIntervention and AgentAdministration classes which identifies the set of agent administrations associated with the study intervention. |
| amendments | A USDM relationship between the StudyVersion and StudyAmendment classes which identifies the set of study amendments associated with the study version. |
| analysisPopulationId | 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. |
| analysisPopulations | |
| appliesToId | A USDM relationship between the DocumentContentReference and StudyDefinitionDocument classes which identifies the study definition document to which the document content reference applies. |
| appliesToIds | 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. |
| armId | A USDM relationship between the StudyCell and StudyArm classes which identifies the study arm associated with a study cell. |
| arms | A USDM relationship between the InterventionalStudyDesign and StudyArm classes which identifies the set of study arms associated with the interventional study design. |
| assignedPersons | 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. |
| bcCategories | |
| bcCategoryIds | A USDM relationship between the Activity and BiomedicalConceptCategory classes which identifies the set of biomedical concept categories associated with the activity. |
| bcSurrogateIds | A USDM relationship between the Activity and BiomedicalConceptSurrogate classes which identifies the set of biomedical concept surrogates associated with the activity. |
| bcSurrogates | |
| biomedicalConceptIds | A USDM relationship between the Activity and BiomedicalConcept classes which identifies the set of biomedical concepts associated with the activity. |
| biomedicalConcepts | |
| biospecimenRetentions | A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention classes which identifies the status of biospecimen retentions related to the interventional study design. |
| blindingSchema | 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. |
| businessTherapeuticAreas | A therapeutic area classification based on the structure and operations of the business unit. |
| category | A classification of the inclusion exclusion criterion. |
| changedSections | A USDM relationship between the StudyChange and DocumentContentReference class which provides the set of changed document sections related to the study change. |
| changes | A USDM relationship between the StudyAmendment and StudyChange classes which identifies the set of changes associated with the study amendment. |
| characteristics | A USDM relationship between the StudyCohort and Characteristic classes which identifies the set of subject characteristics associated with the study cohort. |
| childIds | A USDM relationship within the Activity class which identifies the set of child activities associated with an activity. |
| city | 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. |
| code | A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept. |
| codes | A symbol or combination of symbols which is assigned to the comment annotation. |
| codeSystem | The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes. |
| codeSystemVersion | The version of the code system. |
| cohorts | A USDM relationship between the StudyDesignPopulation and StudyCohort classes which identifies the set of study cohorts associated with the study design population. |
| condition | An assumption on which rests the validity or effect of something else. |
| conditionAssignments | A USDM relationship between the ScheduledDecisionInstance and ConditionAssignment classes which identifies the set of condition assignments associated with a scheduled decision instance. |
| conditions | |
| conditionTargetId | A USDM relationship between the ConditionAssignment and ScheduledInstance classes which identifies the scheduled instance associated with the condition assignment. |
| contactModes | The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device). |
| contentItemId | A USDM relationship between the NarrativeContent and NarrativeContentItem classes which identifies the content item associated with the narrative content. |
| contents | 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. |
| contextIds | 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. |
| country | A sovereign nation occupying a distinct territory and ruled by an autonomous government. |
| criterionIds | A USDM relationship between the StudyCohort and EligibilityCriterion classes which identifies the set of eligibility criteria associated with the study cohort. |
| criterionItemId | A USDM relationship between the EligibilityCriterion and EligibilityCriterionItem classes which identifies the item belonging to the eligibility criterion. |
| dataOriginDescription | The textual representation of the study arm data origin. |
| dataOriginType | A characterization or classification of the study arm with respect to where the study arm data originates. |
| datatype | 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) |
| dateValue | The information contained in the date field. |
| dateValues | A USDM relationship between the StudyAmendment and GovernanceDate classes which provides the set of governance dates associated with the study amendment. |
| decode | Standardized or dictionary-derived human readable text associated with a code. |
| defaultConditionId | A USDM relationship within the ScheduledActivityInstance class which identifies the default condition within a scheduled activity instance. |
| definedProcedures | A USDM relationship between the Activity and Procedure classes which identifies the set of defined procedures associated with the activity. |
| denominator | The divisor of a fraction. |
| description | A narrative representation of the study activity. |
| dictionaries | |
| dictionaryId | A USDM relationship between the Characteristic and SyntaxTemplateDictionary classes which provides the set of dictionary entries related to characteristics. |
| displaySectionNumber | An indication as to whether the section number is to be displayed in the document containing narrative content. |
| displaySectionTitle | An indication as to whether the section title is to be displayed in the document containing narrative content. |
| district | An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic. |
| documentedBy | A USDM relationship between the Study and StudyDefinitionDocument classes signifying that the study is documented in a study definition document. |
| documentVersionIds | A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion classes which identifies the version of the study definition documents associated with the interventional study design. |
| dose | The value representing the amount of an agent given to an individual at one time. |
| duration | The amount of time elapsed during the administration of an agent. |
| durationWillVary | An indication as to whether the event duration is planned to vary within and/or across subjects. |
| elementIds | A USDM relationship between the StudyCell and StudyElement classes which identifies the set of study elements associated with the study cell. |
| elements | A USDM relationship between the InterventionalStudyDesign and StudyElement classes which identifies the set of study elements associated with the interventional study design. |
| eligibilityCriteria | A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion classes which identifies the set of eligibility criterion associated with the interventional study design. |
| eligibilityCriterionItems | |
| embeddedProductId | A USDM relationship between the MedicalDevice and AdministrableProduct classes which identifies the administrable product that is an integral component of the medical device. |
| encounterId | A USDM relationship between the ScheduledActivityInstance and Encounter classes which defines the subject encounter associated with the ScheduleActivityInstance. |
| encounters | A USDM relationship between the InterventionalStudyDesign and Encounter classes which identifies the set of encounters associated with the interventional study design. |
| endpoints | A USDM relationship between the Objective and Endpoint classes which identifies the set of endpoints associated with the study objective. |
| enrollments | A USDM relationship between the StudyAmendment and SubjectEnrollment classes which provides the set of subject enrollments associated with the study amendment. |
| entryCondition | A logical evaluation on which rests the validity of entry into a schedule timeline. |
| entryId | 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. |
| environmentalSettings | The environment/setting where the event, intervention, or finding occurred. |
| epochId | A USDM relationship between the ScheduledActivityInstance and StudyEpoch classes which identifies the study epoch associated with a scheduled activity instance. |
| epochs | A USDM relationship between the InterventionalStudyDesign and StudyEpoch classes which identifies the set of study epochs associated with the interventional study design. |
| estimands | A USDM relationship between the InterventionalStudyDesign and Estimand classes which identifies the set of estimands associated with the interventional study design. |
| exits | A USDM relationship between the ScheduleTimeline and ScheduleTimelineExit classes which identifies the set of exits from the scheduled timeline. |
| expandedText | The full literal representation of the abbreviation. |
| extensionAttributes | |
| familyName | A word or group of words indicating a person's last (family) name. |
| forGeographicScope | A USDM relationship between the SubjectEnrollment and GeographicScope classes which identifies the geographic scope to which the subject enrollment applies. |
| forStudyCohortId | A USDM relationship between the SubjectEnrollment and StudyCohort classes which identifies the study cohort to which the subject enrollment applies. |
| forStudySiteId | A USDM relationship between the SubjectEnrollment and StudySite classes which identifies the study site to which the subject enrollment applies. |
| frequency | The number of doses administered per a specific interval. |
| geographicScopes | A USDM relationship between the GovernanceDate and GeographicScope classes which identifies the set of geographic scopes associated with the governance date. |
| givenNames | A word or group of words indicating a person's first (personal or given) name; the name that precedes the surname. |
| hardwareVersion | 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. |
| id | |
| identifier | A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion. |
| identifiers | A USDM relationship between the AdministrableProduct and AdministrableProductIdentifier classes which provides the set of identifiers related to the administrable product. |
| identifierScheme | The name of the organization that provides the identifier for the entity. |
| impacts | 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. |
| includesDNA | An indication as to whether retained biospecimens contain DNA. |
| includesHealthySubjects | An indication as to whether the study cohort includes healthy subjects, that is, subjects without the disease or condition under study. |
| indicationIds | A USDM relationship between the StudyCohort and Indication classes which identifies the set of indications associated with the study cohort. |
| indications | A USDM relationship between the InterventionalStudyDesign and Indication classes which identifies the set of indications associated with the interventional study design. |
| ingredients | A USDM relationship between the AdministrableProduct and Ingredient classes which provides the set of ingredients related to the administrable product. |
| instances | 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. |
| intentTypes | The planned purpose of the therapy, device, or agent under study in the clinical trial. |
| intercurrentEvents | A USDM relationship between the Estimand and IntercurrentEvent classes which identifies the set of intercurrent events associated with a study estimand. |
| interventionIds | A USDM relationship between the Estimand and StudyIntervention classes which identifies the set of study interventions associated with the Estimand. |
| isApproximate | An indication as to whether the value range is almost, but not quite, exact. |
| isEnabled | An indication as to whether the biomedical concept property is activated for use within a given usage context for a biomedical concept. |
| isMasked | An indication as to whether the study role is masked. |
| isRareDisease | An indication as to whether the disease/condition indication under study is considered a rare disease. |
| isRequired | An indication as to whether the biomedical concept property is required. |
| isRetained | An indication as to whether biospecimens were retained. |
| isSubstantial | An indication as to whether the study amendment's impact on the study is substantial. |
| jobTitle | An identifying designation related to the assigned person's occupation. |
| label | The short descriptive designation for the study activity. |
| language | The language in which the study definition document is written. |
| legalAddress | A USDM relationship between the Organization and Address classes which provides the legal address for an organization. |
| level | A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints. |
| lines | The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located. |
| mainTimeline | An indication as to whether the timeline or timeline component is part of the central or principal timeline. |
| managedSites | A USDM relationship between the Organization and StudySite classes which identifies the set of study sites managed by the organization. |
| masking | A USDM relationship between the StudyRole and Masking classes which describes the masking associated with the study role. |
| maxValue | The largest value in quantity or degree in a set of values. |
| medicalDeviceId | A USDM relationship between the Administration and MedicalDevice classes which identifies the medical device associated with an instance of product, agent, or therapy administration. |
| medicalDevices | |
| memberIds | A USDM relationship between the BiomedicalConceptCategory and BiomedicalConcept classes which identifies the set of biomedical concept members associated with the biomedical concept category. |
| minimumResponseDuration | The value representing the minimum amount of time required to meet the criteria for response to study intervention. |
| minValue | The smallest value in quantity or degree in a set of values. |
| model | The general design of the strategy for assigning interventions to subjects in a clinical study. (clinicaltrials.gov) |
| name | The literal identifier (i.e., distinctive designation) of the study activity. |
| narrativeContentItems | |
| nextId | A USDM relationship within the Activity class which identifies the activity that follows the current activity in the display order. |
| notes | A brief written record relevant to the abbreviation. |
| number | A string of numerals that uniquely identifies a protocol amendment. |
| numerator | The dividend of a fraction. |
| objectives | A USDM relationship between the InterventionalStudyDesign and Objective classes which identifies the set of objectives associated with the interventional study design. |
| organizationId | A USDM relationship between the AssignedPerson and Organization classes that identifies that organization to which the assigned person belongs. |
| organizationIds | A USDM relationship between the StudyRole and Organization classes which identifies the set of organizations associated with the study role. |
| organizations | |
| otherReason | The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified. |
| parameterMaps | 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. |
| personName | 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. |
| pharmacologicClass | The pharmacological class of the administrable product. |
| plannedAge | The anticipated age of subjects within the study cohort. |
| plannedCompletionNumber | 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. |
| plannedDuration | The period of time over which the scheduled timeline is intended to take place. |
| plannedEnrollmentNumber | The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort. |
| plannedSex | The protocol-defined sex within the study cohort. |
| population | A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation classes which identifies the population associated with the interventional study design. |
| populationIds | A USDM relationship between the StudyArm and PopulationDefinition classes which identifies the set of populations associated with the study arm. |
| populationSummary | A synopsis of the clinical endpoint of interest within the analysis target study population. |
| postalCode | An alphanumeric code assigned to a mail delivery area. |
| prefixes | An affix occurring at the start of the person name string, usually denoting a title or honorific. |
| previousId | A USDM relationship within the Activity class which identifies the activity that precedes the current activity in the display order. |
| primaryReason | A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the primary reason for issuing the study amendment. |
| procedureType | A characterization or classification of the study procedure. |
| productDesignation | An indication as to whether the administrable product is an investigational medicinal product or an auxiliary medicinal product. |
| productOrganizationRoles | |
| properties | A USDM relationship between the AdministrableProduct and AdministrableProductProperty classes which provides the set of properties related to the administrable product. |
| purpose | The textual representation of the study endpoint purpose. |
| quantity | The numeric value associated with an administrable product property. |
| rationale | An explanation as to the logical reasons for why a study change has occurred. |
| reasonDurationWillVary | The explanation for why the event duration will vary within and/or across subjects. |
| reference | A citation to an authoritative source for a biomedical concept. |
| referenceIdentifiers | A USDM relationship between the StudyVersion and ReferenceIdentifier classes which identifies the set of reference identifiers associated with the study version. |
| referenceSubstance | 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. |
| relativeFromScheduledInstanceId | 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. |
| relativeToFrom | The name of the reference event used to define the temporal relationship with another event. |
| relativeToScheduledInstanceId | 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. |
| responseCodes | A USDM relationship between the BiomedicalConceptProperty and ResponseCode classes which identifies the set of response codes associated with the biomedical concept property. |
| role | The intended use of the ingredient within the context of the compounded substance or mixture. |
| roles | |
| route | The pathway by which a substance is administered in order to reach the site of action in the body. |
| samplingMethod | The sampling method used to assign study participants into groups or cohorts within an observational study. |
| scheduledAtId | A USDM relationship between the Encounter and Timing classes which provides information related to the scheduled timing of an encounter. |
| scheduleTimelines | A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline classes which identifies the set of scheduled timelines associated with the interventional study design. |
| scopeId | 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. |
| secondaryReasons | A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the set of secondary reasons for issuing the study amendment. |
| sectionNumber | The numeric identifier of a particular section for the document content reference. |
| sectionTitle | An identifying designation for a particular section for the document content reference. |
| softwareVersion | A form or variant of software; one of a sequence of copies of a software program, each incorporating new modifications. (NCI) |
| sourcing | An indication as to whether the administrable product is obtained from a local or central source. |
| standardCode | A combination of symbols that is used to represent the standard code. |
| standardCodeAliases | Alternative combinations of symbols used to represent aliases or alternatives to the standard code. |
| state | 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. |
| status | A condition of the study definition document at a point in time with respect to its state of readiness for implementation. |
| strategy | A textual description of the planned strategy to manage and/or mitigate intercurrent events. |
| strengths | A USDM relationship between the Substance and Strength class which provides the values of the strengths of the substance. |
| studyCells | A USDM relationship between the InterventionalStudyDesign and StudyCell classes which identifies the set of study cells associated with the interventional study design. |
| studyDesigns | A USDM relationship between the StudyVersion and StudyDesign classes which identifies the set of study designs associated with the study version. |
| studyIdentifiers | A USDM relationship between the StudyVersion and StudyIdentifier classes which identifies the set of study identifiers associated with the study version. |
| studyInterventionId | 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. |
| studyInterventionIds | A USDM relationship between the InterventionalStudyDesign and StudyIntervention classes which identifies the set of study interventions associated with interventional study design. |
| studyInterventions | |
| studyPhase | The study phase associated with the interventional study design. |
| studyType | The study type associated with the interventional study design. |
| subsetOfIds | A USDM relationship between the AnalysisPopulation and PopulationDefinition classes which identifies the population definition of which the analysis population is a subset. |
| substance | A USDM relationship between the Ingredient and Substance classes that identifies the substance associated with the ingredient. |
| subTypes | The nature of the interventional study for which information is being collected. |
| suffixes | An affix occurring at the end of the person name, usually denoting educational or professional degrees and certifications, and/or filial rank. |
| summary | A short narrative representation describing the changes introduced in the current version of the protocol. |
| synonyms | A word or an expression that serves as a figurative, symbolic, or exact substitute for a biomedical concept, and which has the same meaning. |
| tag | Character strings bounded by angle brackets that act as containers for programming language elements. |
| templateName | The literal identifier (i.e., distinctive designation) of the study definition document template. |
| text | A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization. |
| therapeuticAreas | 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. |
| timelineExitId | 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. |
| timelineId | 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. |
| timePerspective | The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov) |
| timings | A USDM relationship between the ScheduleTimeline and Timing classes which identifies the set of timings associated with the scheduled timeline. |
| titles | A USDM relationship between the StudyVersion and StudyTitle classes which identifies the set of study titles associated with the study version. |
| transitionEndRule | 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. |
| transitionStartRule | 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. |
| type | A characterization or classification of the administrable product property. |
| unit | The type of unit of measure being used to express a quantity. |
| url | |
| value | A numerical quantity measured or assigned or computed. |
| valueAliasCode | |
| valueBoolean | |
| valueCode | |
| valueExtensionClass | |
| valueId | |
| valueInteger | |
| valueLabel | The short descriptive designation for the timing value. |
| valueQuantity | |
| valueRange | |
| valueString | |
| variableOfInterestId | 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. |
| version | A sequence of characters used to identify the version of the study definition document. |
| versionIdentifier | A sequence of characters used to identify, name, or characterize the study version. |
| versions | A USDM relationship between the Study and StudyVersion classes which identifies the set of versions associated with the study. |
| windowLabel | The short descriptive designation for a time period, or other type of interval, during which a temporal event may be achieved, obtained, or observed. |
| windowLower | The earliest chronological value of an allowable period of time during which a temporal event takes place. |
| windowUpper | The latest chronological value of an allowable period of time during which a temporal event takes place. |
Types
| Type | Description |
|---|---|
| boolean | A binary (true or false) value |
| curie | a compact URI |
| date | a date (year, month and day) in an idealized calendar |
| date_or_datetime | Either a date or a datetime |
| datetime | The combination of a date and time |
| decimal | A real number with arbitrary precision that conforms to the xsd:decimal specification |
| double | A real number that conforms to the xsd:double specification |
| float | A real number that conforms to the xsd:float specification |
| integer | An integer |
| jsonpath | A string encoding a JSON Path. The value of the string MUST conform to JSON Point syntax and SHOULD dereference to zero or more valid objects within the current instance document when encoded in tree form. |
| jsonpointer | A string encoding a JSON Pointer. The value of the string MUST conform to JSON Point syntax and SHOULD dereference to a valid object within the current instance document when encoded in tree form. |
| ncname | Prefix part of CURIE |
| nodeidentifier | A URI, CURIE or BNODE that represents a node in a model. |
| objectidentifier | A URI or CURIE that represents an object in the model. |
| sparqlpath | A string encoding a SPARQL Property Path. The value of the string MUST conform to SPARQL syntax and SHOULD dereference to zero or more valid objects within the current instance document when encoded as RDF. |
| string | A character string |
| time | A time object represents a (local) time of day, independent of any particular day |
| uri | a complete URI |
| uriorcurie | a URI or a CURIE |