Define-JSON

Data model for supply and demand data contracts to complement CDISC USDM, ODM, and Dataset-JSON. This LinkML version includes semantics to act as Rosetta Stone for SDMX, FHIR, OMOP, RDF, and CDISC.

URI: https://cdisc.org/define-json

Name: Define-JSON

Schema Diagram

erDiagram
MetaDataVersion {
    stringList resources  
    string fileOID  
    datetime asOfDateTime  
    datetime creationDateTime  
    string odmVersion  
    string fileType  
    string originator  
    string sourceSystem  
    string sourceSystemVersion  
    string context  
    string defineVersion  
    string studyOID  
    string studyName  
    string studyDescription  
    string protocolName  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Comment {
    string text  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Coding {
    string code  
    string decode  
    string codeSystem  
    string codeSystemVersion  
    AliasPredicate aliasType  
}
DocumentReference {
    string title  
    string leafID  
    integerList pages  
    string relationship  
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
DataProduct {
    string dataProductOwner  
    string domain  
    DataProductLifecycleStatus lifecycleStatus  
    stringList hasPolicy  
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Dataset {
    string publishedBy  
    stringList keys  
    string datasetType  
    string conformsTo  
    stringList hasPolicy  
    string informationSensitivityClassification  
    string version  
    string href  
    stringList profile  
    string authenticator  
    string action  
    string reportingBegin  
    string reportingEnd  
    string dataExtractionDate  
    string validFrom  
    string validTo  
    string publicationYear  
    string publicationPeriod  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Timing {
    TimingType type  
    boolean isNominal  
    string value  
    datetime windowLower  
    datetime windowUpper  
    boolean recalled  
    string frequency  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Method {
    MethodType type  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
FormalExpression {
    string context  
    string expression  
    string returnType  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Resource {
    string resourceType  
    string attribute  
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
ReturnValue {
    DataType dataType  
    stringList valueList  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Parameter {
    DataType dataType  
    string value  
    stringList items  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
ConceptProperty {
    integer minOccurs  
    integer maxOccurs  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
CodeList {
    DataType dataType  
    string formatName  
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
CodeListItem {
    string codedValue  
    string decode  
    string description  
    stringList aliases  
    decimal weight  
    boolean other  
}
NominalOccurrence {
    string event  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Condition {
    string implementsCondition  
    LogicalOperator operator  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
RangeCheck {
    Comparator comparator  
    stringList checkValues  
    string item  
    SoftHard softHard  
    LogicalOperator operator  
}
Distribution {
    string conformsTo  
    string format  
}
DataService {
    string protocol  
    string securitySchemaType  
    string resourceType  
    string attribute  
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
DataStructureDefinition {
    boolean evolvingStructure  
    string domain  
    string structure  
    boolean isReferenceData  
    ItemGroupType type  
    stringList children  
    stringList profile  
    string authenticator  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
    string version  
    string href  
}
WhereClause {
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
ReifiedConcept {
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Item {
    DataType dataType  
    integer length  
    string role  
    boolean hasNoData  
    string crfCompletionInstructions  
    string cdiscNotes  
    string implementationNotes  
    string preSpecifiedValue  
    integer decimalDigits  
    string displayFormat  
    integer significantDigits  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Origin {
    OriginType type  
    OriginSource source  
}
SourceItem {
    stringList resource  
}
ComponentList {
    stringList components  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
DataAttribute {
    string role  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Measure {
    string role  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Dimension {
    integer keySequence  
    string role  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Dataflow {
    string version  
    string href  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
}
Standard {
    StandardName name  
    StandardType type  
    PublishingSet publishingSet  
    string version  
    StandardStatus status  
    string OID  
    string uuid  
    string description  
    string label  
    stringList aliases  
}
Dictionary {
    string publishedBy  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
Relationship {
    PredicateTermEnum predicateTerm  
    LinkingPhraseEnum linkingPhrase  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
IdentifiableElement {
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
}
ItemGroup {
    string domain  
    string structure  
    boolean isReferenceData  
    ItemGroupType type  
    stringList children  
    stringList profile  
    string authenticator  
    string OID  
    string uuid  
    string name  
    string description  
    string label  
    stringList aliases  
    boolean mandatory  
    string purpose  
    datetime lastUpdated  
    string owner  
    string wasDerivedFrom  
    string version  
    string href  
}

MetaDataVersion ||--}o ItemGroup : "itemGroups"
MetaDataVersion ||--}o Item : "items"
MetaDataVersion ||--}o Condition : "conditions"
MetaDataVersion ||--}o WhereClause : "whereClauses"
MetaDataVersion ||--}o Method : "methods"
MetaDataVersion ||--}o CodeList : "codeLists"
MetaDataVersion ||--}o Coding : "codings"
MetaDataVersion ||--}o ReifiedConcept : "concepts"
MetaDataVersion ||--}o Relationship : "relationships"
MetaDataVersion ||--}o Dictionary : "dictionaries"
MetaDataVersion ||--}o Standard : "standards"
MetaDataVersion ||--}o DocumentReference : "annotatedCRFs"
MetaDataVersion ||--}o DataProduct : "dataProducts"
MetaDataVersion ||--}o Coding : "coding"
MetaDataVersion ||--}o Comment : "comments"
MetaDataVersion ||--}o Comment : "siteOrSponsorComments"
Comment ||--}o DocumentReference : "documents"
Comment ||--}o Coding : "coding"
DocumentReference ||--}o Coding : "coding"
DataProduct ||--}o DataService : "inputPort"
DataProduct ||--}o DataService : "outputPort"
DataProduct ||--}o Dataset : "inputDataset"
DataProduct ||--}o Dataset : "outputDataset"
DataProduct ||--}o Coding : "coding"
DataProduct ||--}o Comment : "comments"
DataProduct ||--}o Comment : "siteOrSponsorComments"
Dataset ||--|o Dataflow : "describedBy"
Dataset ||--|o DataStructureDefinition : "structuredBy"
Dataset ||--}o Distribution : "distribution"
Dataset ||--}o Coding : "security"
Dataset ||--|o Timing : "validityPeriod"
Dataset ||--}o Coding : "coding"
Timing ||--|o NominalOccurrence : "relativeTo"
Timing ||--|o NominalOccurrence : "relativeFrom"
Timing ||--|o Method : "imputation"
Timing ||--}o Coding : "coding"
Method ||--}o FormalExpression : "formalExpressions"
Method ||--|o DocumentReference : "document"
Method ||--}o Coding : "coding"
Method ||--}o Comment : "comments"
Method ||--}o Comment : "siteOrSponsorComments"
FormalExpression ||--}o Parameter : "parameters"
FormalExpression ||--|o ReturnValue : "returnValue"
FormalExpression ||--}o Resource : "externalCodeLibs"
FormalExpression ||--}o Coding : "coding"
Resource ||--}o FormalExpression : "selection"
Resource ||--}o Coding : "coding"
ReturnValue ||--}o Coding : "coding"
Parameter ||--}o CodeList : "codeList"
Parameter ||--}o ConceptProperty : "conceptProperty"
Parameter ||--}o Coding : "coding"
ConceptProperty ||--|o CodeList : "codeList"
ConceptProperty ||--}o Coding : "coding"
ConceptProperty ||--}o Comment : "comments"
ConceptProperty ||--}o Comment : "siteOrSponsorComments"
CodeList ||--}o CodeListItem : "codeListItems"
CodeList ||--|o Resource : "externalCodeList"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Comment : "comments"
CodeList ||--}o Comment : "siteOrSponsorComments"
CodeListItem ||--|o Coding : "coding"
NominalOccurrence ||--|| Timing : "timing"
NominalOccurrence ||--}o Condition : "condition"
NominalOccurrence ||--}o Coding : "coding"
NominalOccurrence ||--}o Comment : "comments"
NominalOccurrence ||--}o Comment : "siteOrSponsorComments"
Condition ||--}o RangeCheck : "rangeChecks"
Condition ||--}o FormalExpression : "formalExpression"
Condition ||--}o Condition : "conditions"
Condition ||--}o Coding : "coding"
Condition ||--}o Comment : "comments"
Condition ||--}o Comment : "siteOrSponsorComments"
RangeCheck ||--}o FormalExpression : "formalExpression"
Distribution ||--|o DataService : "accessService"
Distribution ||--|o Dataset : "isDistributionOf"
DataService ||--|o Distribution : "isAccessServiceOf"
DataService ||--}o FormalExpression : "selection"
DataService ||--}o Coding : "coding"
DataStructureDefinition ||--}o Dimension : "dimensions"
DataStructureDefinition ||--}o Measure : "measures"
DataStructureDefinition ||--}o DataAttribute : "attributes"
DataStructureDefinition ||--|o ComponentList : "grouping"
DataStructureDefinition ||--}o Item : "items"
DataStructureDefinition ||--|o ReifiedConcept : "implementsConcept"
DataStructureDefinition ||--}o WhereClause : "whereClauses"
DataStructureDefinition ||--}o Coding : "security"
DataStructureDefinition ||--|o Timing : "validityPeriod"
DataStructureDefinition ||--}o Coding : "coding"
DataStructureDefinition ||--}o Comment : "comments"
DataStructureDefinition ||--}o Comment : "siteOrSponsorComments"
WhereClause ||--}o Condition : "conditions"
WhereClause ||--}o Coding : "coding"
ReifiedConcept ||--}o ConceptProperty : "properties"
ReifiedConcept ||--}o Coding : "coding"
ReifiedConcept ||--}o Comment : "comments"
ReifiedConcept ||--}o Comment : "siteOrSponsorComments"
Item ||--|o CodeList : "codeList"
Item ||--|o Method : "method"
Item ||--}o RangeCheck : "rangeChecks"
Item ||--}o WhereClause : "whereClauses"
Item ||--|o Origin : "origin"
Item ||--|o ConceptProperty : "conceptProperty"
Item ||--|o CodeList : "roleCodeList"
Item ||--|o Condition : "collectionExceptionCondition"
Item ||--}o Coding : "coding"
Item ||--}o Comment : "comments"
Item ||--}o Comment : "siteOrSponsorComments"
Origin ||--}o SourceItem : "sourceItems"
Origin ||--|o DocumentReference : "document"
SourceItem ||--|o Item : "item"
SourceItem ||--|o DocumentReference : "document"
SourceItem ||--}o Coding : "coding"
ComponentList ||--}o Coding : "coding"
DataAttribute ||--|| Item : "item"
DataAttribute ||--|o Method : "missingHandling"
DataAttribute ||--|o Method : "imputation"
DataAttribute ||--}o Coding : "coding"
DataAttribute ||--}o Comment : "comments"
DataAttribute ||--}o Comment : "siteOrSponsorComments"
Measure ||--|| Item : "item"
Measure ||--|o Method : "missingHandling"
Measure ||--|o Method : "imputation"
Measure ||--}o Coding : "coding"
Measure ||--}o Comment : "comments"
Measure ||--}o Comment : "siteOrSponsorComments"
Dimension ||--|| Item : "item"
Dimension ||--|o Method : "missingHandling"
Dimension ||--|o Method : "imputation"
Dimension ||--}o Coding : "coding"
Dimension ||--}o Comment : "comments"
Dimension ||--}o Comment : "siteOrSponsorComments"
Dataflow ||--|| DataStructureDefinition : "structure"
Dataflow ||--}o Dimension : "dimensionConstraint"
Dataflow ||--}o Coding : "coding"
Dataflow ||--}o Comment : "comments"
Dataflow ||--}o Comment : "siteOrSponsorComments"
Standard ||--}o Coding : "coding"
Dictionary ||--}o Coding : "terms"
Dictionary ||--}o Coding : "coding"
Relationship ||--|| IdentifiableElement : "subject"
Relationship ||--|| IdentifiableElement : "object"
Relationship ||--}o Coding : "coding"
IdentifiableElement ||--}o Coding : "coding"
ItemGroup ||--}o Item : "items"
ItemGroup ||--|o ReifiedConcept : "implementsConcept"
ItemGroup ||--}o WhereClause : "whereClauses"
ItemGroup ||--}o Coding : "security"
ItemGroup ||--|o Timing : "validityPeriod"
ItemGroup ||--}o Coding : "coding"
ItemGroup ||--}o Comment : "comments"
ItemGroup ||--}o Comment : "siteOrSponsorComments"

Classes

Class	Description
CodeListItem	A structured member of a CodeList that extends the Coding class with additional context-specific properties
Coding	A semantic reference that provides standardized codes and their meanings from controlled vocabularies
DataflowRelationship	A relationship element that associates a DataAttribute with a Dataflow, reported at the Dataset level
DatasetKey	An abstract identifier that comprises the cross-product of dimension values to identify a specific cross-section
GroupKey	A dimension subset that represents collections of dimensions that are subsets of the full dimension set, distinct from SeriesKey which includes Time dimensions
SeriesKey	A unique identifier that comprises the cross-product of dimension values including Time to identify observations, representing dimensions shared by all observations in a conceptual series
DimensionRelationship	A relationship element that associates a DataAttribute with a specific Dimension at a specific level
Distribution	A technical representation that provides a specific format or access method for a dataset
Formatted	A mixin that provides slots for reporting, exchange, or storage formatting
Governed	A mixin that provides slots for audit trail and standards governance, including mandatory status, comments, and attribution
GovernedElement
CodeList	A value set that defines a discrete collection of permissible values for an item, corresponding to the ODM CodeList construct
ConceptProperty	A reified property concept that exists within the context of its containing topic concept
Condition	A reusable, composable, and nestable logical construct allowing for complex expressions. Conditions are most useful when given a meaningful name and linked to Study Definitions.
CubeComponent	An abstract data field that represents a component in a data structure definition, referencing an Item for its definition
DataAttribute	A data cube property that describes additional characteristics or metadata about observations
Dimension	A data cube property that describes a categorical or hierarchical dimension
Measure	A data cube property that describes a measurable quantity or value
Dataflow	An abstract representation that defines data provision for different reference periods, where a Distribution and its Dataset are instances
DataProduct	A governed collection that represents a purpose-driven assembly of datasets and services with an owning team and lifecycle
Item	A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods
ItemGroup	A collection element that groups related items or subgroups within a specific context, used for tables, FHIR resource profiles, biomedical concept specializations, or form sections
DataStructureDefinition	A structural element that defines the organization of a data cube for analysis, including dimensions, attributes, and measures
MetaDataVersion	A container element that represents a given version of a specification, linking to a particular usage context such as a study, dataset, or data collection instrument.
Method	A reusable computational procedure that describes how to derive values and can be referenced by Items
NominalOccurrence	An event element that represents occurrences such as planned or unplanned encounters or adverse events
ProvisionAgreement	An agreement element that describes the contractual relationship between a Data Provider and a Data Consumer regarding data provision
ReifiedConcept	A canonical information layer that makes abstract concepts explicit and referenceable, showing how different data implementations represent the same underlying meanings through a star schema structure with multiple properties
SiteOrSponsorComment	A feedback element that contains comments from a site or sponsor, distinct from the general Comment class
GroupRelationship	A relationship element that associates a DataAttribute with a set of Dimensions, used when attribute values vary based on all group dimension values
Identifiable	A mixin that provides slots for making an entity addressable within a study or context
IdentifiableElement
Comment	A descriptive element that contains explanatory text provided by a data or metadata handler
ComponentList	An abstract definition that specifies a list of components within a data structure definition, including various descriptor types
Dataset	A collection element that groups observations sharing the same dimensionality, expressed as a set of unique dimensions within a Data Product context
Dictionary	A dictionary that defines a set of codes and their meanings
DocumentReference	A comprehensive reference element that points to an external document, combining elements from ODM and FHIR
FormalExpression	A computational element that defines the execution of a data derivation within a specific context
Organization	An entity that represents organizational information, such as a site or sponsor
DataProvider	An organization element that provides data to a Data Consumer, which can be a sponsor, site, or any other entity that supplies data
Parameter	A variable element that describes an input used in a formal expression
Relationship	A semantic link that defines connections between elements such as Items or ItemGroups, capturing relationships like "is the unit for" or "assesses seriousness of"
Resource	An external reference that serves as the source for a Dataset, ItemGroup, or Item
DataService	A service element that provides an API or endpoint for serving or receiving data
ReturnValue	An output specification that defines the details of what a formal expression returns
Standard	A collection element that groups related standards within a specific context, used for defining CDISC implementation guides and controlled terminologies
Timing	A temporal element that describes the timing of an event or occurrence, which can be absolute, relative, or nominal
User	An entity that represents information about a specific user of a clinical data collection or data management system
WhereClause	A conditional element that describes the circumstances under which a containing context applies, linking conditions to structures where they are used
IsODMItem	A mixin that provides additional attributes for CDISC Operational Data Model items, including roles, completion instructions, and implementation notes
IsProfile	A mixin that provides additional metadata for FHIR resources and Data Products, including profiles, security tags, and validity periods
IsSdmxDataset	A mixin that provides additional metadata specific to SDMX Datasets
Labelled	A mixin that provides slots for detailing meanings and multilingual descriptions
MeasureRelationship	A relationship element that associates a DataAttribute with a Measure
ObservationRelationship	A relationship element that associates a DataAttribute with an Observation, allowing value-level Items to be reused across multiple different Views
ODMFileMetadata	A mixin that provides ODM file-level metadata attributes including file identifiers, timestamps, and system information
Origin	A provenance element that describes the source of data for an item
RangeCheck	A validation element that performs a simple comparison check between a referenced item's value and specified values, resolving to a boolean result
SourceItem	A data source that provides the origin of information for an item
StudyMetadata	A mixin that provides study-level metadata attributes including study identification and protocol information
TranslatedText
Translation	A text representation that provides content in a specific language, used for multilingual support
Versioned	A mixin that provides version and connectivity information, including version numbers and resource references

Slots

Slot	Description
OID	Local identifier within this study/context. Use CDISC OID format for regulatory submissions, or simple strings for internal use.
uuid	Universal unique identifier
mandatory	Is this element required?
comments	Comment on the element, such as a rationale for its inclusion or exclusion
siteOrSponsorComments	Comment on the element, such as a rationale for its inclusion or exclusion
purpose	Purpose or rationale for this data element
lastUpdated	When the resource was last updated
owner	Party responsible for this element
wasDerivedFrom	Reference to another item that this item implements or extends, e.g. a template Item definition.
name	Short name or identifier, used for field names
description	Detailed description, shown in tooltips
coding	Semantic tags for this element
label	Human-readable label, shown in UIs
aliases	Alternative name or identifier
decimalDigits	For decimal values, the number of digits after the decimal point
displayFormat	A display format for the item
significantDigits	For numeric values, the number of significant digits
version	The version of the external resources
href	Machine-readable instructions to obtain the resource e.g. FHIR path, URL
profile	Profiles this resource claims to conform to
security	Security tags applied to this resource
authenticator	Who/what authenticated the resource
validityPeriod	Time period during which the resouce is valid
role	Identifies the role of the item within the containing context, taken from the roleCodeList
roleCodeList	Reference to the CodeList that defines the roles for this item
hasNoData	Set to Yes if this is a manifest and there is no data for this item
crfCompletionInstructions	CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF
cdiscNotes	CDISCNotes reference: Explanatory text for the variable
implementationNotes	ImplementationNotes reference: Further information, such as rationale and implementation instructions, on how to implement the CRF data collection fields
collectionExceptionCondition	Condition that defines when collection may be exempted
preSpecifiedValue	Prefill value or a default value for a field that is automatically populated.
fileOID	Unique identifier for the ODM file
asOfDateTime	Date and time when the data snapshot was taken
creationDateTime	Date and time when the ODM file was created
odmVersion	Version of the ODM standard used
fileType	Type of ODM file (e.g., Snapshot, Transactional)
originator	Organization or system that created the ODM file
sourceSystem	Source system that generated the data
sourceSystemVersion	Version of the source system
context	Define-XML context (usually "Other" for Define-XML)
defineVersion	Version of Define-XML specification used
studyOID	Unique identifier for the study
studyName	Name of the study
studyDescription	Description of the study
protocolName	Protocol name for the study
itemGroups	Item groups, containing items, defined in this version of the metadata
items	Template or top-level items (not belonging to any item group) defined in this version of the metadata
resources	References to documents that describe this version of the metadata.
conditions	Logical conditions that apply to this version of the metadata.
whereClauses	Data contexts that apply to this version of the metadata.
methods	Methods defined in this version of the metadata.
codeLists	Code lists defined in this version of the metadata.
codings	Codings defined in this version of the metadata
concepts	Structured Concepts defined in this version of the metadata
relationships	Relationships between items, item groups, and other elements in this version of the metadata.
dictionaries	Dictionaries defined in this version of the metadata
standards	Standards defined in this version of the metadata
annotatedCRFs	Reference to annotated case report forms
dataProducts	Indexed data flows with clear ownership
dataType	The data type of the item.
length	The maximum length of the data item in characters.
codeList	Reference to the CodeList that constrains the item values.
method	Reference to the Method element that describes how to derive this item's value.
rangeChecks	Range checks applied to this item (e.g. edit checks, CORE rules)
origin	The origin of the data
conceptProperty	Reference to a abstract concept property that this item is a specialization / instance of.
domain	Domain abbreviation for the dataset.
structure	Data structure of the item group, indicating how the records are organized. If this is a FHIR Resource, is it nested or flattened? If this is a structured concept, is it a Biomedical/Derivation/Analysis concept?
isReferenceData	Set to Yes if this is a reference item group.
type	Type of item group
children	References to child ItemGroups (OIDs) within this item group. Use these OID references to look up the actual ItemGroup objects from the top-level itemGroups collection.
implementsConcept	Reference to a abstract concept topic that this item group is a specialization of
subject	The starting element of the relationship (e.g., an Item or ItemGroup).
object	The ending element of the relationship.
predicateTerm	Short variable relationship linking phrase for programming purposes.
linkingPhrase	Variable relationship descriptive linking phrase.
language	The language of the translation
value	The translated text
translations
formatName	Name of a standard format definition
codeListItems	The individual values that make up this CodeList. The type of CodeListItem included determines its behaviour
externalCodeList	Reference to a code list that is defined externally to this study
codedValue	The value of the CodeListItem before decoding
decode	The decoded value of the CodeListItem
weight	Numeric significance of the code (e.g., for scoring)
other	Flag to indicate that the term represents "other" content
text	The comment text.
documents	References to documents that contain or are referenced by this comment
code	The code value
codeSystem	The code system identifier
codeSystemVersion	The code system version
aliasType	How this coding is related in the context of its parent element
terms	Terms in this dictionary - leave this empty in most cases to keep the file small
publishedBy	Associates the Data Provider that reports/publishes the data.
properties	Properties of the reified object, which can be other governed elements or simple values
minOccurs	Minimum number of occurrences of this property in the context. Set to >0 to mandate some number of occurrences
maxOccurs	Maximum number of occurrences of this property in the context. Leave empty for unbounded. Set to 0 to disable property
implementsCondition	Reference to a external (e.g. USDM) condition definition that this implements
formalExpression	Logical expression, resolving to a boolean, that implements this condition in a specific context
operator	Logical operator for combining child conditions or range checks. Defaults to ALL if not specified.
comparator	The type of comparison to be performed
checkValues	Values to compare against
item	Reference to the Item element whose value is being checked. If not specified, check applies to the enclosing context
softHard	Indicates whether a validation check is an error ("Hard") or a warning ("Soft")
expression	The actual text of the formal expression (renamed from 'code' for disambiguation).
returnType	Return type of the expression
parameters	Parameters used in the expression
returnValue	Return value details
externalCodeLibs	External code libraries referenced
formalExpressions	Formal expressions used by this method
document	Reference to a document that describes this method in detail.
resource	Path to a resource (e.g. File, FHIR datasource) that is the source of this item
valueList	A list of possible return values.
source	The source of the data, such as Investigator, Sponsor, Subject, or Vendor.
sourceItems	Source items for this origin
sourceType	who made the comment, such as Investigator, Sponsor.
userType	User's role in the study.
userName	The username of the user.
fullName	The full name of the user.
organization	The organization the user belongs to.
location	The physical location of the organization.
address	The address of the organization.
partOfOrganization	Reference to a parent organization if this organization is part of a larger entity.
publishingSet	Publishing Set of a Controlled Terminology
status	Status of an Implementation Guide or of a Controlled Terminology
resourceType	Type of resource (e.g., "ODM", "HL7-FHIR", "HL7-CDA", "HL7-v2", "OpenEHR-extract")
attribute	Field provided by the Name attribute where the data or information can be obtained. Examples are "valueQuantity.value" or "valueQuantity.unit".
selection	Machine-executable instructions for selecting data from the resource.
title	Document title
leafID	Leaf identifier for document reference in Define-XML
pages	Reference to specific pages in a PDF document
relationship	Relationship to the referencing entity
isNominal	Indicates whether the timing is nominal (event-based) or not.
relativeTo	Reference to the event or occurrence that this timing is relative to.
relativeFrom	Reference to the event or occurrence that this timing is relative to.
windowLower	Start date/time of the timing
windowUpper	End date/time of the timing
recalled	Indicates whether the timing is recalled or not (recalled timings are less reliable).
frequency	Frequency. Use dose frequency terminology e.g. "BID" if applicable.
imputation	The imputation method used for the Timing.
timing	A named event reference, that can nest further named timing references.
event	The ID of the event in a Schedule.
condition	A condition that must be met for this occurrence to be valid.
dimensions
measures
attributes
grouping	An association to a set of metadata concepts that have an identified structural role in a Data Structure Definition.
evolvingStructure
dimensionConstraint
action	Defines the action to be taken by the recipient system (information, append, replace, delete)
reportingBegin	A specific time period in a known system of time periods that identifies the start period of a report.
reportingEnd	A specific time period in a known system of time periods that identifies the end period of a report.
dataExtractionDate	A specific time period that identifies the date and time that the data are extracted from a data source.
validFrom	Indicates the inclusive start time indicating the validity of the information in the data set.
validTo	Indicates the inclusive end time indicating the validity of the information in the data set.
publicationYear	Specifies the year of publication of the data or metadata in terms of whatever provisioning agreements might be in force.
publicationPeriod	Specifies the period of publication of the data or metadata in terms of whatever provisioning agreements might be in force.
describedBy	Associates a Dataflow and thereby a Data Structure Definition to the data set.
structuredBy	Associates the Data Structure Definition that defines the structure of the Data Set. Note that the Data Structure Definition is the same as that associated (non-mandatory) to the Dataflow.
keys	Series and Group keys in the data that are associated with dimensions in this structure
datasetType	Type or classification of the dataset
distribution	Representations of this dataset in various formats or access methods
conformsTo	Specification or standard that this dataset conforms to
hasPolicy	Access or usage policy applied to this dataset
informationSensitivityClassification	Classification of the dataset's sensitivity or confidentiality
keyValues	List of Key Values that comprise each key, separated by a dot e.g. SUBJ001.VISIT2.BMI
attributeValues	Association to the Attribute Values relating to Key
missingHandling	The method for handling missing values in the measure property
keySequence
components	The components that make up this component list
measure
dataFlow
groupKey	Set of dimensions that this definition depends on
dataProductOwner	The person or team accountable for this data product
lifecycleStatus	Current lifecycle status of the data product
inputPort	Services that provide input into this data product
outputPort	Services that expose output from this data product
inputDataset	Source datasets used by the data product
outputDataset	Output datasets produced by the data product
accessService	Service that provides access to this distribution
isDistributionOf	Dataset this distribution represents
format	File format or serialization used in the distribution
isAccessServiceOf	Distribution(s) for which this service provides access
protocol	Protocol used by the service (e.g., HTTPS, FTP)
securitySchemaType	Security or authentication method used (e.g., OAuth2)
providesDataFor	The Dataflows that this provider supplies data for
provisionAgreements	The ProvisionAgreements that this provider has with Data Consumers
provider	The Data Provider that is part of this agreement

Enumerations

Enumeration	Description
AliasPredicate	An enumeration that defines permissible values for the relationship between an element and its alias
Comparator	An enumeration that defines the types of comparison operations available for a RangeCheck
UserType	An enumeration that defines the types of users in a clinical data collection or management system
OrganizationType	An enumeration that defines the types of organizations involved in clinical research
SoftHard	An enumeration that indicates whether a validation check should be treated as an error or a warning
MethodType	An enumeration that defines the types of computational methods available for data processing
DataType	An enumeration that defines the fundamental data types available for items
OriginType	An enumeration that defines the types of origins for data items
OriginSource	An enumeration that defines the sources of data origin
ItemGroupType	An enumeration that defines the roles of an item group within a specific context
TimingType	An enumeration that defines CDISC timing type values indicating the temporal relationship of an observation to a reference point
LinkingPhraseEnum	An enumeration that defines variable relationship descriptive linking phrases from the COSMoS SDTM BC model
PredicateTermEnum	An enumeration that defines short variable relationship linking phrases for programming purposes from the COSMoS SDTM BC model
DataProductLifecycleStatus	An enumeration that defines the lifecycle stages for a DataProduct
StandardName	An enumeration that defines permissible values for standard names
StandardType	An enumeration that defines permissible values for standard types
PublishingSet	An enumeration that defines permissible values for publishing sets
StandardStatus	An enumeration that defines permissible values for standard status
LogicalOperator	Logical operators for combining conditions in Boolean expressions. For complex expressions, use the EXPRESSION value.

Types

Type	Description
String	A character string
Integer	An integer
Boolean	A binary (true or false) value
Float	A real number that conforms to the xsd:float specification
Double	A real number that conforms to the xsd:double specification
Decimal	A real number with arbitrary precision that conforms to the xsd:decimal specification
Time	A time object represents a (local) time of day, independent of any particular day
Date	a date (year, month and day) in an idealized calendar
Datetime	The combination of a date and time
DateOrDatetime	Either a date or a datetime
Uriorcurie	a URI or a CURIE
Curie	a compact URI
Uri	a complete URI
Ncname	Prefix part of CURIE
Objectidentifier	A URI or CURIE that represents an object in the model.
Nodeidentifier	A URI, CURIE or BNODE that represents a node in a model.
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.
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.
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.

Subsets

Subset	Description