Class: MetaDataVersion

The metadata for a study is defined in a series of MetaDataVersion elements. Through this mechanism (multiple MetaDataVersion elements), the model supports the incremental deployment of "mid-stream study changes," and thus can handle a situation where multiple versions of the metadata are being used simultaneously (e.g., due to delays in IRB approval at various sites).

URI: odm:MetaDataVersion

erDiagram
MetaDataVersion {
    oid OID  
    nameType name  
}
Leaf {
    oid ID  
    uriorcurie href  
}
Title {
    text content  
}
CommentDef {
    oid OID  
}
DocumentRef {
    oid leafID  
}
Description {

}
MethodDef {
    oid OID  
    nameType name  
    MethodType type  
}
Alias {
    text context  
    text name  
}
FormalExpression {
    text context  
}
MethodSignature {

}
ConditionDef {
    oid OID  
    nameType name  
}
CodeList {
    oid OID  
    nameType name  
    CLDataType dataType  
    YesOnly isNonStandard  
}
Coding {
    text code  
    uriorcurie system  
    text systemName  
    text systemVersion  
    text label  
    uriorcurie href  
    uriorcurie ref  
    text commentOID  
}
CodeListItem {
    valueType codedValue  
    decimal rank  
    YesOnly other  
    positiveInteger orderNumber  
    YesOnly extendedValue  
}
Standard {
    oid OID  
    StandardName name  
    StandardType type  
    StandardPublishingSet publishingSet  
    text version  
    StandardStatus status  
}
ItemDef {
    oid OID  
    nameType name  
    DataType dataType  
    positiveInteger length  
    text displayFormat  
    text variableSet  
}
ValueListRef {

}
CodeListRef {

}
RangeCheck {
    Comparator comparator  
    SoftOrHard softHard  
}
CDISCNotes {

}
ImplementationNotes {

}
CRFCompletionInstructions {

}
Prompt {

}
Question {

}
Definition {

}
ItemGroupDef {
    oid OID  
    nameType name  
    ItemGroupRepeatingType repeating  
    positiveInteger repeatingLimit  
    YesOrNo isReferenceData  
    text structure  
    nameType datasetName  
    text domain  
    ItemGroupTypeType type  
    text purpose  
    YesOnly isNonStandard  
    YesOnly hasNoData  
}
ItemRef {
    positiveInteger keySequence  
    YesOnly isNonStandard  
    YesOnly hasNoData  
    YesOnly repeat  
    YesOnly other  
    text role  
    CoreType core  
    text preSpecifiedValue  
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
ItemGroupRef {
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
Origin {
    OriginType type  
    OriginSource source  
}
WorkflowRef {

}
Class {
    ItemGroupClass name  
}
StudyEventDef {
    oid OID  
    nameType name  
    YesOrNo repeating  
    EventType type  
    text category  
}
StudyEventGroupDef {
    oid OID  
    nameType name  
}
StudyEventRef {
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
StudyEventGroupRef {
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
Epoch {
    oid OID  
    nameType name  
    positiveInteger sequenceNumber  
}
Arm {
    oid OID  
    nameType name  
}
WorkflowDef {
    oid OID  
    nameType name  
}
Branching {
    oid OID  
    nameType name  
    BranchingType type  
}
Transition {
    oid OID  
    nameType name  
    string sourceOID  
    string targetOID  
}
WorkflowEnd {
    string endOID  
    text content  
}
WorkflowStart {
    string startOID  
}
Protocol {

}
InclusionExclusionCriteria {

}
StudyEstimands {

}
StudyTargetPopulation {
    oid OID  
    nameType name  
}
StudyEndPoints {

}
StudyObjectives {

}
StudyInterventions {

}
StudyIndications {

}
StudyTimings {

}
TrialPhase {
    TrialPhaseType value  
}
StudyStructure {

}
StudySummary {

}
WhereClauseDef {
    oid OID  
}
ValueListDef {
    oid OID  
}
SupplementalDoc {

}
AnnotatedCRF {

}
Standards {

}
Include {
    uriorcurie href  
}
Study {
    oid OID  
    nameType studyName  
    nameType protocolName  
    nameType versionID  
    nameType versionName  
    nameType status  
}

MetaDataVersion ||--|o CommentDef : "commentOID"
MetaDataVersion ||--|o Description : "description"
MetaDataVersion ||--|o Include : "include"
MetaDataVersion ||--|o Standards : "standards"
MetaDataVersion ||--|o AnnotatedCRF : "annotatedCRF"
MetaDataVersion ||--|o SupplementalDoc : "supplementalDoc"
MetaDataVersion ||--}o ValueListDef : "valueListDef"
MetaDataVersion ||--}o WhereClauseDef : "whereClauseDef"
MetaDataVersion ||--|o Protocol : "protocol"
MetaDataVersion ||--}o WorkflowDef : "workflowDef"
MetaDataVersion ||--}o StudyEventGroupDef : "studyEventGroupDef"
MetaDataVersion ||--}o StudyEventDef : "studyEventDef"
MetaDataVersion ||--}o ItemGroupDef : "itemGroupDef"
MetaDataVersion ||--}o ItemDef : "itemDef"
MetaDataVersion ||--}o CodeList : "codeList"
MetaDataVersion ||--}o ConditionDef : "conditionDef"
MetaDataVersion ||--}o MethodDef : "methodDef"
MetaDataVersion ||--}o CommentDef : "commentDef"
MetaDataVersion ||--}o Leaf : "leaf"
Leaf ||--|o Title : "title"
CommentDef ||--|o Description : "description"
CommentDef ||--}o DocumentRef : "documentRef"
DocumentRef ||--}o PDFPageRef : "pDFPageRef"
Description ||--}o TranslatedText : "translatedText"
MethodDef ||--|o CommentDef : "commentOID"
MethodDef ||--|o Description : "description"
MethodDef ||--|o MethodSignature : "methodSignature"
MethodDef ||--}o FormalExpression : "formalExpression"
MethodDef ||--}o Alias : "alias"
MethodDef ||--}o DocumentRef : "documentRef"
FormalExpression ||--|o Code : "code"
FormalExpression ||--|o ExternalCodeLib : "externalCodeLib"
MethodSignature ||--}o Parameter : "parameter"
MethodSignature ||--}o ReturnValue : "returnValue"
ConditionDef ||--|o CommentDef : "commentOID"
ConditionDef ||--|o Description : "description"
ConditionDef ||--|o MethodSignature : "methodSignature"
ConditionDef ||--}o FormalExpression : "formalExpression"
ConditionDef ||--}o Alias : "alias"
CodeList ||--|o CommentDef : "commentOID"
CodeList ||--|o Standard : "standardOID"
CodeList ||--|o Description : "description"
CodeList ||--}o CodeListItem : "codeListItem"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Alias : "alias"
CodeListItem ||--|o CommentDef : "commentOID"
CodeListItem ||--|o Description : "description"
CodeListItem ||--|o Decode : "decode"
CodeListItem ||--}o Coding : "coding"
CodeListItem ||--}o Alias : "alias"
Standard ||--|o CommentDef : "commentOID"
ItemDef ||--|o CommentDef : "commentOID"
ItemDef ||--|o Description : "description"
ItemDef ||--|o Definition : "definition"
ItemDef ||--|o Question : "question"
ItemDef ||--|o Prompt : "prompt"
ItemDef ||--|o CRFCompletionInstructions : "cRFCompletionInstructions"
ItemDef ||--|o ImplementationNotes : "implementationNotes"
ItemDef ||--|o CDISCNotes : "cDISCNotes"
ItemDef ||--}o RangeCheck : "rangeCheck"
ItemDef ||--|o CodeListRef : "codeListRef"
ItemDef ||--|o ValueListRef : "valueListRef"
ItemDef ||--}o Coding : "coding"
ItemDef ||--}o Alias : "alias"
ValueListRef ||--|| ValueListDef : "valueListOID"
CodeListRef ||--|| CodeList : "codeListOID"
RangeCheck ||--|o ItemDef : "itemOID"
RangeCheck ||--|o ErrorMessage : "errorMessage"
RangeCheck ||--|o MethodSignature : "methodSignature"
RangeCheck ||--}o FormalExpression : "formalExpression"
RangeCheck ||--}o CheckValue : "checkValue"
CDISCNotes ||--}o TranslatedText : "translatedText"
ImplementationNotes ||--}o TranslatedText : "translatedText"
CRFCompletionInstructions ||--}o TranslatedText : "translatedText"
Prompt ||--}o TranslatedText : "translatedText"
Question ||--}o TranslatedText : "translatedText"
Definition ||--}o TranslatedText : "translatedText"
ItemGroupDef ||--|o Leaf : "archiveLocationID"
ItemGroupDef ||--|o Standard : "standardOID"
ItemGroupDef ||--|o CommentDef : "commentOID"
ItemGroupDef ||--|o Description : "description"
ItemGroupDef ||--|o Class : "itemGroupClass"
ItemGroupDef ||--}o Coding : "coding"
ItemGroupDef ||--|o WorkflowRef : "workflowRef"
ItemGroupDef ||--}o Origin : "origin"
ItemGroupDef ||--}o Alias : "alias"
ItemGroupDef ||--|o Leaf : "leaf"
ItemGroupDef ||--}o ItemGroupRef : "itemGroupRef"
ItemGroupDef ||--}o ItemRef : "itemRef"
ItemRef ||--|| ItemDef : "itemOID"
ItemRef ||--|o MethodDef : "methodOID"
ItemRef ||--|o ItemDef : "unitsItemOID"
ItemRef ||--|o CodeList : "roleCodeListOID"
ItemRef ||--|o ConditionDef : "collectionExceptionConditionOID"
ItemRef ||--}o Origin : "origin"
ItemRef ||--}o WhereClauseRef : "whereClauseRef"
ItemGroupRef ||--|| ItemGroupDef : "itemGroupOID"
ItemGroupRef ||--|o MethodDef : "methodOID"
ItemGroupRef ||--|o ConditionDef : "collectionExceptionConditionOID"
Origin ||--|o Description : "description"
Origin ||--|o SourceItems : "sourceItems"
Origin ||--}o Coding : "coding"
Origin ||--}o DocumentRef : "documentRef"
WorkflowRef ||--|| WorkflowDef : "workflowOID"
Class ||--}o SubClass : "subClass"
StudyEventDef ||--|o CommentDef : "commentOID"
StudyEventDef ||--|o Description : "description"
StudyEventDef ||--}o ItemGroupRef : "itemGroupRef"
StudyEventDef ||--|o WorkflowRef : "workflowRef"
StudyEventDef ||--}o Coding : "coding"
StudyEventDef ||--}o Alias : "alias"
StudyEventGroupDef ||--|o Arm : "armOID"
StudyEventGroupDef ||--|o Epoch : "epochOID"
StudyEventGroupDef ||--|o CommentDef : "commentOID"
StudyEventGroupDef ||--|o Description : "description"
StudyEventGroupDef ||--|o WorkflowRef : "workflowRef"
StudyEventGroupDef ||--}o Coding : "coding"
StudyEventGroupDef ||--}o StudyEventGroupRef : "studyEventGroupRef"
StudyEventGroupDef ||--}o StudyEventRef : "studyEventRef"
StudyEventRef ||--|| StudyEventDef : "studyEventOID"
StudyEventRef ||--|o ConditionDef : "collectionExceptionConditionOID"
StudyEventGroupRef ||--|| StudyEventGroupDef : "studyEventGroupOID"
StudyEventGroupRef ||--|o ConditionDef : "collectionExceptionConditionOID"
StudyEventGroupRef ||--|o Description : "description"
Epoch ||--|o Description : "description"
Arm ||--|o Description : "description"
Arm ||--|o WorkflowRef : "workflowRef"
WorkflowDef ||--|o Description : "description"
WorkflowDef ||--|o WorkflowStart : "workflowStart"
WorkflowDef ||--}o WorkflowEnd : "workflowEnd"
WorkflowDef ||--}o Transition : "transition"
WorkflowDef ||--}o Branching : "branching"
Branching ||--}o TargetTransition : "targetTransition"
Branching ||--}o DefaultTransition : "defaultTransition"
Transition ||--|o ConditionDef : "startConditionOID"
Transition ||--|o ConditionDef : "endConditionOID"
Protocol ||--|o Description : "description"
Protocol ||--|o StudySummary : "studySummary"
Protocol ||--|o StudyStructure : "studyStructure"
Protocol ||--|o TrialPhase : "trialPhase"
Protocol ||--|o StudyTimings : "studyTimings"
Protocol ||--|o StudyIndications : "studyIndications"
Protocol ||--|o StudyInterventions : "studyInterventions"
Protocol ||--|o StudyObjectives : "studyObjectives"
Protocol ||--|o StudyEndPoints : "studyEndPoints"
Protocol ||--|o StudyTargetPopulation : "studyTargetPopulation"
Protocol ||--|o StudyEstimands : "studyEstimands"
Protocol ||--|o InclusionExclusionCriteria : "inclusionExclusionCriteria"
Protocol ||--}o StudyEventGroupRef : "studyEventGroupRef"
Protocol ||--|o WorkflowRef : "workflowRef"
Protocol ||--}o Alias : "alias"
InclusionExclusionCriteria ||--|o InclusionCriteria : "inclusionCriteria"
InclusionExclusionCriteria ||--|o ExclusionCriteria : "exclusionCriteria"
StudyEstimands ||--}o StudyEstimand : "studyEstimand"
StudyTargetPopulation ||--|o Description : "description"
StudyTargetPopulation ||--}o Coding : "coding"
StudyTargetPopulation ||--}o FormalExpression : "formalExpression"
StudyEndPoints ||--}o StudyEndPoint : "studyEndPoint"
StudyObjectives ||--}o StudyObjective : "studyObjective"
StudyInterventions ||--}o StudyIntervention : "studyIntervention"
StudyIndications ||--}o StudyIndication : "studyIndication"
StudyTimings ||--}o StudyTiming : "studyTiming"
TrialPhase ||--|o Description : "description"
StudyStructure ||--|o Description : "description"
StudyStructure ||--}o Arm : "arm"
StudyStructure ||--}o Epoch : "epoch"
StudyStructure ||--|o WorkflowRef : "workflowRef"
StudySummary ||--}o StudyParameter : "studyParameter"
WhereClauseDef ||--|o CommentDef : "commentOID"
WhereClauseDef ||--}o RangeCheck : "rangeCheck"
ValueListDef ||--|o Description : "description"
ValueListDef ||--}o ItemRef : "itemRef"
SupplementalDoc ||--}o DocumentRef : "documentRef"
AnnotatedCRF ||--}o DocumentRef : "documentRef"
Standards ||--}o Standard : "standard"
Include ||--|| Study : "studyOID"
Include ||--|| MetaDataVersion : "metaDataVersionOID"
Study ||--|o Description : "description"
Study ||--}o MetaDataVersion : "metaDataVersion"

Slots

Name Cardinality* and Range Description Inheritance
OID 1..1
oid		 Unique identifier. direct
name 1..1
nameType		 MetaDataVersion name. direct
commentOID 0..1
CommentDef		 Reference to a CommentDef element. direct
description 0..1
Description		 Description reference: A free-text description of the containing metadata com... direct
include 0..1
Include		 Include reference: The Include metadata element allows a reference to a prior... direct
standards 0..1
Standards		 Standards reference: The Standards element provides a container for the list ... direct
annotatedCRF 0..1
AnnotatedCRF		 AnnotatedCRF reference: An Annotated Case Report Form (CRF) is a Portable Fil... direct
supplementalDoc 0..1
SupplementalDoc		 SupplementalDoc reference: Supplemental data definitions direct
valueListDef 0..*
ValueListDef		 ValueListDef reference: The following table specifies the XML structure for v... direct
whereClauseDef 0..*
WhereClauseDef		 WhereClauseDef reference: The WhereClauseDef element specifies a condition. direct
protocol 0..1
Protocol		 Protocol reference: The Protocol element lists the kinds of study events that... direct
workflowDef 0..*
WorkflowDef		 WorkflowDef reference: A WorkflowDef defines an automated workflow for a stud... direct
studyEventGroupDef 0..*
StudyEventGroupDef		 StudyEventGroupDef reference: StudyEventGroupDef is a study building block th... direct
studyEventDef 0..*
StudyEventDef		 StudyEventDef reference: StudyEventDef represents the definition of an activi... direct
itemGroupDef 0..*
ItemGroupDef		 ItemGroupDef reference: An ItemGroupDef describes a type of variable or field... direct
itemDef 0..*
ItemDef		 ItemDef reference: An ItemDef describes a type of item that can occur within ... direct
codeList 0..*
CodeList		 CodeList reference: Defines a discrete set of permitted values for an item, o... direct
conditionDef 0..*
ConditionDef		 ConditionDef reference: A ConditionDef defines a boolean condition. direct
methodDef 0..*
MethodDef		 MethodDef reference: A MethodDef defines how a data value can be obtained fro... direct
commentDef 0..*
CommentDef		 CommentDef reference: The Comment element allows referencing short comments s... direct
leaf 0..*
Leaf		 Leaf reference: Contains the XLink information referenced by DocumentRef or A... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
Study metaDataVersion range MetaDataVersion
Include metaDataVersionOID range MetaDataVersion
SourceItem metaDataVersionOID range MetaDataVersion
MetaDataVersionRef metaDataVersionOID range MetaDataVersion
ReferenceData metaDataVersionOID range MetaDataVersion
ClinicalData metaDataVersionOID range MetaDataVersion
Association metaDataVersionOID range MetaDataVersion
KeySet metaDataVersionOID range MetaDataVersion

See Also

Identifier and Mapping Information

Schema Source

  • from schema: http://www.cdisc.org/ns/odm/v2.0

Mappings

Mapping Type Mapped Value
self odm:MetaDataVersion
native odm:MetaDataVersion

LinkML Source

Direct

name: MetaDataVersion
description: The metadata for a study is defined in a series of MetaDataVersion elements.
  Through this mechanism (multiple MetaDataVersion elements), the model supports the
  incremental deployment of "mid-stream study changes," and thus can handle a situation
  where multiple versions of the metadata are being used simultaneously (e.g., due
  to delays in IRB approval at various sites).
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/MetaDataVersion
rank: 1000
slots:
- OID
- name
- commentOID
- description
- include
- standards
- annotatedCRF
- supplementalDoc
- valueListDef
- whereClauseDef
- protocol
- workflowDef
- studyEventGroupDef
- studyEventDef
- itemGroupDef
- itemDef
- codeList
- conditionDef
- methodDef
- commentDef
- leaf
slot_usage:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: MetaDataVersion name.
    comments:
    - 'Required

      range: name'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  commentOID:
    name: commentOID
    description: Reference to a CommentDef element.
    comments:
    - 'Optional

      range: oidref'
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  include:
    name: include
    domain_of:
    - MetaDataVersion
    range: Include
    maximum_cardinality: 1
  standards:
    name: standards
    domain_of:
    - MetaDataVersion
    range: Standards
    maximum_cardinality: 1
  annotatedCRF:
    name: annotatedCRF
    domain_of:
    - MetaDataVersion
    range: AnnotatedCRF
    maximum_cardinality: 1
  supplementalDoc:
    name: supplementalDoc
    domain_of:
    - MetaDataVersion
    range: SupplementalDoc
    maximum_cardinality: 1
  valueListDef:
    name: valueListDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ValueListDef
    inlined: true
    inlined_as_list: true
  whereClauseDef:
    name: whereClauseDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: WhereClauseDef
    inlined: true
    inlined_as_list: true
  protocol:
    name: protocol
    domain_of:
    - MetaDataVersion
    range: Protocol
    maximum_cardinality: 1
  workflowDef:
    name: workflowDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: WorkflowDef
    inlined: true
    inlined_as_list: true
  studyEventGroupDef:
    name: studyEventGroupDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: StudyEventGroupDef
    inlined: true
    inlined_as_list: true
  studyEventDef:
    name: studyEventDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: StudyEventDef
    inlined: true
    inlined_as_list: true
  itemGroupDef:
    name: itemGroupDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ItemGroupDef
    inlined: true
    inlined_as_list: true
  itemDef:
    name: itemDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ItemDef
    inlined: true
    inlined_as_list: true
  codeList:
    name: codeList
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: CodeList
    inlined: true
    inlined_as_list: true
  conditionDef:
    name: conditionDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ConditionDef
    inlined: true
    inlined_as_list: true
  methodDef:
    name: methodDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: MethodDef
    inlined: true
    inlined_as_list: true
  commentDef:
    name: commentDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: CommentDef
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    multivalued: true
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    inlined: true
    inlined_as_list: true
class_uri: odm:MetaDataVersion

Induced

name: MetaDataVersion
description: The metadata for a study is defined in a series of MetaDataVersion elements.
  Through this mechanism (multiple MetaDataVersion elements), the model supports the
  incremental deployment of "mid-stream study changes," and thus can handle a situation
  where multiple versions of the metadata are being used simultaneously (e.g., due
  to delays in IRB approval at various sites).
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/MetaDataVersion
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: MetaDataVersion name.
    comments:
    - 'Required

      range: name'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  commentOID:
    name: commentOID
    description: Reference to a CommentDef element.
    comments:
    - 'Optional

      range: oidref'
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  include:
    name: include
    domain_of:
    - MetaDataVersion
    range: Include
    maximum_cardinality: 1
  standards:
    name: standards
    domain_of:
    - MetaDataVersion
    range: Standards
    maximum_cardinality: 1
  annotatedCRF:
    name: annotatedCRF
    domain_of:
    - MetaDataVersion
    range: AnnotatedCRF
    maximum_cardinality: 1
  supplementalDoc:
    name: supplementalDoc
    domain_of:
    - MetaDataVersion
    range: SupplementalDoc
    maximum_cardinality: 1
  valueListDef:
    name: valueListDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ValueListDef
    inlined: true
    inlined_as_list: true
  whereClauseDef:
    name: whereClauseDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: WhereClauseDef
    inlined: true
    inlined_as_list: true
  protocol:
    name: protocol
    domain_of:
    - MetaDataVersion
    range: Protocol
    maximum_cardinality: 1
  workflowDef:
    name: workflowDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: WorkflowDef
    inlined: true
    inlined_as_list: true
  studyEventGroupDef:
    name: studyEventGroupDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: StudyEventGroupDef
    inlined: true
    inlined_as_list: true
  studyEventDef:
    name: studyEventDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: StudyEventDef
    inlined: true
    inlined_as_list: true
  itemGroupDef:
    name: itemGroupDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ItemGroupDef
    inlined: true
    inlined_as_list: true
  itemDef:
    name: itemDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ItemDef
    inlined: true
    inlined_as_list: true
  codeList:
    name: codeList
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: CodeList
    inlined: true
    inlined_as_list: true
  conditionDef:
    name: conditionDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: ConditionDef
    inlined: true
    inlined_as_list: true
  methodDef:
    name: methodDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: MethodDef
    inlined: true
    inlined_as_list: true
  commentDef:
    name: commentDef
    multivalued: true
    domain_of:
    - MetaDataVersion
    range: CommentDef
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    multivalued: true
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    inlined: true
    inlined_as_list: true
attributes:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: MetaDataVersion
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: MetaDataVersion name.
    comments:
    - 'Required

      range: name'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: name
    owner: MetaDataVersion
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  commentOID:
    name: commentOID
    description: Reference to a CommentDef element.
    comments:
    - 'Optional

      range: oidref'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: commentOID
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    description: 'Description reference: A free-text description of the containing
      metadata component, unless restricted by Business Rules.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: description
    owner: MetaDataVersion
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  include:
    name: include
    description: 'Include reference: The Include metadata element allows a reference
      to a prior metadata version.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: include
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: Include
    maximum_cardinality: 1
  standards:
    name: standards
    description: 'Standards reference: The Standards element provides a container
      for the list of Standard elements referenced in the MetaDataVersion for the
      Study..'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: standards
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: Standards
    maximum_cardinality: 1
  annotatedCRF:
    name: annotatedCRF
    description: 'AnnotatedCRF reference: An Annotated Case Report Form (CRF) is a
      Portable File Format (PDF) document that provides the mapping of data collection
      fields to the variables or discrete variable values contained within the datasets.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: annotatedCRF
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: AnnotatedCRF
    maximum_cardinality: 1
  supplementalDoc:
    name: supplementalDoc
    description: 'SupplementalDoc reference: Supplemental data definitions'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: supplementalDoc
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: SupplementalDoc
    maximum_cardinality: 1
  valueListDef:
    name: valueListDef
    description: 'ValueListDef reference: The following table specifies the XML structure
      for valuelist metadata. The ValueListDef element contains ItemRef elements that
      reference ItemDef elements that provide the value-level metadata details'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: valueListDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: ValueListDef
    inlined: true
    inlined_as_list: true
  whereClauseDef:
    name: whereClauseDef
    description: 'WhereClauseDef reference: The WhereClauseDef element specifies a
      condition.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: whereClauseDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: WhereClauseDef
    inlined: true
    inlined_as_list: true
  protocol:
    name: protocol
    description: 'Protocol reference: The Protocol element lists the kinds of study
      events that can occur within a specific version of a study. All clinical data
      must occur within one of these study events.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: protocol
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: Protocol
    maximum_cardinality: 1
  workflowDef:
    name: workflowDef
    description: 'WorkflowDef reference: A WorkflowDef defines an automated workflow
      for a study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: workflowDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: WorkflowDef
    inlined: true
    inlined_as_list: true
  studyEventGroupDef:
    name: studyEventGroupDef
    description: 'StudyEventGroupDef reference: StudyEventGroupDef is a study building
      block that groups a number of smaller building blocks, which can themselves
      be StudyEventGroups or StudyEvents. It thus allows nesting of building blocks.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: studyEventGroupDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: StudyEventGroupDef
    inlined: true
    inlined_as_list: true
  studyEventDef:
    name: studyEventDef
    description: 'StudyEventDef reference: StudyEventDef represents the definition
      of an activity in a study where data is collected. For example, a study event
      may represent a set of item groups that represent data collection instruments
      to be completed for a subject during a visit in a study. The visit occurs as
      part of a study workflow, and the workflow is referenced in the study event.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: studyEventDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: StudyEventDef
    inlined: true
    inlined_as_list: true
  itemGroupDef:
    name: itemGroupDef
    description: 'ItemGroupDef reference: An ItemGroupDef describes a type of variable
      or field grouping that can occur within a study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: itemGroupDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: ItemGroupDef
    inlined: true
    inlined_as_list: true
  itemDef:
    name: itemDef
    description: 'ItemDef reference: An ItemDef describes a type of item that can
      occur within a study. Item properties include name, datatype, range, or codelist
      restrictions, and several other properties.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: itemDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: ItemDef
    inlined: true
    inlined_as_list: true
  codeList:
    name: codeList
    description: 'CodeList reference: Defines a discrete set of permitted values for
      an item, or provides a reference to a codelist or dictionary maintained by an
      external organization via the Coding element, or a combination of both. Examples
      provided under Coding.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: codeList
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: CodeList
    inlined: true
    inlined_as_list: true
  conditionDef:
    name: conditionDef
    description: 'ConditionDef reference: A ConditionDef defines a boolean condition.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: conditionDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: ConditionDef
    inlined: true
    inlined_as_list: true
  methodDef:
    name: methodDef
    description: 'MethodDef reference: A MethodDef defines how a data value can be
      obtained from a collection of other data values.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: methodDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: MethodDef
    inlined: true
    inlined_as_list: true
  commentDef:
    name: commentDef
    description: 'CommentDef reference: The Comment element allows referencing short
      comments self-contained in the XML document or long comments normally included
      in external documents. For comments included in external documents, the reference
      could include specific pages of a document where the comments are included.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: commentDef
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    range: CommentDef
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    description: 'Leaf reference: Contains the XLink information referenced by DocumentRef
      or ArchiveLocationID'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: leaf
    owner: MetaDataVersion
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    inlined: true
    inlined_as_list: true
class_uri: odm:MetaDataVersion