Class: ODMFileMetadata

Root element for ODM Documents. The ODM element is the top-level (root) element of each ODM document.

URI: odm:ODM

erDiagram
ODMFileMetadata {
    FileType fileType  
    Granularity granularity  
    Context context  
    oid fileOID  
    datetime creationDateTime  
    datetime asOfDateTime  
    ODMVersion oDMVersion  
    text originator  
    text sourceSystem  
    text sourceSystemVersion  
}
Association {

}
Annotation {
    positiveInteger seqNum  
    TransactionType transactionType  
    oid ID  
}
KeySet {
    subjectKeyType subjectKey  
    repeatKey studyEventRepeatKey  
    repeatKey itemGroupRepeatKey  
}
MetaDataVersion {
    oid OID  
    nameType name  
}
Study {
    oid OID  
    nameType studyName  
    nameType protocolName  
    nameType versionID  
    nameType versionName  
    nameType status  
}
ClinicalData {

}
Signature {
    oid ID  
}
AuditRecord {
    EditPointType editPoint  
    YesOrNo usedMethod  
}
Query {
    oid OID  
    QuerySourceType source  
    text target  
    QueryType type  
    QueryStateType state  
    datetime lastUpdateDatetime  
    nameType name  
}
ItemGroupData {
    repeatKey itemGroupRepeatKey  
    TransactionType transactionType  
    positiveInteger itemGroupDataSeq  
}
SubjectData {
    subjectKeyType subjectKey  
    TransactionType transactionType  
}
ReferenceData {

}
AdminData {

}
SignatureDef {
    oid OID  
    SignMethod methodology  
}
Location {
    oid OID  
    nameType name  
    text role  
}
Organization {
    oid OID  
    nameType name  
    text role  
    OrganizationType type  
}
User {
    oid OID  
    UserType userType  
}
Description {

}
TranslatedText {
    languageType language  
    text type  
    contentType content  
}

ODMFileMetadata ||--|o ODMFileMetadata : "priorFileOID"
ODMFileMetadata ||--|o Description : "description"
ODMFileMetadata ||--}o Study : "study"
ODMFileMetadata ||--}o AdminData : "adminData"
ODMFileMetadata ||--}o ReferenceData : "referenceData"
ODMFileMetadata ||--}o ClinicalData : "clinicalData"
ODMFileMetadata ||--}o Association : "association"
Association ||--|| Study : "studyOID"
Association ||--|| MetaDataVersion : "metaDataVersionOID"
Association ||--|o KeySet : "keySet"
Association ||--|o Annotation : "annotation"
Annotation ||--|o Comment : "comment"
Annotation ||--}o Coding : "coding"
Annotation ||--}o Flag : "flag"
KeySet ||--|| Study : "studyOID"
KeySet ||--|o MetaDataVersion : "metaDataVersionOID"
KeySet ||--|o StudyEventDef : "studyEventOID"
KeySet ||--|o ItemGroupDef : "itemGroupOID"
KeySet ||--|o ItemDef : "itemOID"
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"
Study ||--|o Description : "description"
Study ||--}o MetaDataVersion : "metaDataVersion"
ClinicalData ||--|| Study : "studyOID"
ClinicalData ||--|| MetaDataVersion : "metaDataVersionOID"
ClinicalData ||--}o SubjectData : "subjectData"
ClinicalData ||--}o ItemGroupData : "itemGroupData"
ClinicalData ||--}o Query : "query"
ClinicalData ||--|o AuditRecord : "auditRecord"
ClinicalData ||--|o Signature : "signature"
ClinicalData ||--|o Annotation : "annotation"
Signature ||--|o UserRef : "userRef"
Signature ||--|o LocationRef : "locationRef"
Signature ||--|o SignatureRef : "signatureRef"
Signature ||--|o DateTimeStamp : "dateTimeStamp"
AuditRecord ||--|o UserRef : "userRef"
AuditRecord ||--|o LocationRef : "locationRef"
AuditRecord ||--|o DateTimeStamp : "dateTimeStamp"
AuditRecord ||--|o ReasonForChange : "reasonForChange"
AuditRecord ||--|o SourceID : "sourceID"
Query ||--|o Value : "value"
Query ||--}o AuditRecord : "auditRecord"
ItemGroupData ||--|| ItemGroupDef : "itemGroupOID"
ItemGroupData ||--}o Query : "query"
ItemGroupData ||--}o ItemGroupData : "itemGroupData"
ItemGroupData ||--}o ItemData : "itemData"
ItemGroupData ||--|o AuditRecord : "auditRecord"
ItemGroupData ||--|o Signature : "signature"
ItemGroupData ||--|o Annotation : "annotation"
SubjectData ||--|o InvestigatorRef : "investigatorRef"
SubjectData ||--|o SiteRef : "siteRef"
SubjectData ||--}o StudyEventData : "studyEventData"
SubjectData ||--}o Query : "query"
SubjectData ||--|o AuditRecord : "auditRecord"
SubjectData ||--|o Signature : "signature"
SubjectData ||--|o Annotation : "annotation"
ReferenceData ||--|| Study : "studyOID"
ReferenceData ||--|| MetaDataVersion : "metaDataVersionOID"
ReferenceData ||--}o ItemGroupData : "itemGroupData"
ReferenceData ||--|o AuditRecord : "auditRecord"
ReferenceData ||--|o Signature : "signature"
ReferenceData ||--|o Annotation : "annotation"
AdminData ||--|o Study : "studyOID"
AdminData ||--}o User : "user"
AdminData ||--}o Organization : "organization"
AdminData ||--}o Location : "location"
AdminData ||--}o SignatureDef : "signatureDef"
SignatureDef ||--|o Meaning : "meaning"
SignatureDef ||--|o LegalReason : "legalReason"
Location ||--|o Organization : "organizationOID"
Location ||--|o Description : "description"
Location ||--}o MetaDataVersionRef : "metaDataVersionRef"
Location ||--}o Address : "address"
Location ||--}o Telecom : "telecom"
Location ||--}o Query : "query"
Organization ||--|o Location : "locationOID"
Organization ||--|o Organization : "partOfOrganizationOID"
Organization ||--|o Description : "description"
Organization ||--}o Address : "address"
Organization ||--}o Telecom : "telecom"
User ||--|o Organization : "organizationOID"
User ||--|o Location : "locationOID"
User ||--|o UserName : "userName"
User ||--|o Prefix : "prefix"
User ||--|o Suffix : "suffix"
User ||--|o FullName : "fullName"
User ||--|o GivenName : "givenName"
User ||--|o FamilyName : "familyName"
User ||--|o Image : "image"
User ||--}o Address : "address"
User ||--}o Telecom : "telecom"
Description ||--}o TranslatedText : "translatedText"

Slots

Name Cardinality* and Range Description Inheritance
fileType 1..1
FileType		 Snapshot means that the document contains only the current state of the data ... direct
granularity 0..1
Granularity		 Granularity is intended to give the sender a shorthand way to Describes the s... direct
context 0..1
Context		 Indicates the intended usage of the ODM document. Archive - indicates that th... direct
fileOID 1..1
oid		 A unique identifier for this file. direct
creationDateTime 1..1
datetime		 Time of creation of the file containing the document. direct
priorFileOID 0..1
ODMFileMetadata		 Reference to the previous file (if any) in a series. direct
asOfDateTime 0..1
datetime		 The date/time at which the source database was queried in order to create thi... direct
oDMVersion 0..1
ODMVersion		 The version of the ODM standard used. direct
originator 0..1
text		 The organization that generated the ODM file. direct
sourceSystem 0..1
text		 The computer system or database management system that is the source of the i... direct
sourceSystemVersion 0..1
text		 The version of the "SourceSystem" above. direct
description 0..1
Description		 Description reference: A free-text description of the containing metadata com... direct
study 0..*
Study		 Study reference: This element collects static structural information about an... direct
adminData 0..*
AdminData		 AdminData reference: Administrative information about users, locations, organ... direct
referenceData 0..*
ReferenceData		 ReferenceData reference: Reference data provides information on how to interp... direct
clinicalData 0..*
ClinicalData		 ClinicalData reference: Clinical data for 1 or more subjects. direct
association 0..*
Association		 Association reference: An association permits an annotation to be placed on a... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
ODMFileMetadata priorFileOID range ODMFileMetadata

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:ODM
native odm:ODMFileMetadata

LinkML Source

Direct

name: ODMFileMetadata
description: Root element for ODM Documents. The ODM element is the top-level (root)
  element of each ODM document.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ODM
rank: 1000
slots:
- fileType
- granularity
- context
- fileOID
- creationDateTime
- priorFileOID
- asOfDateTime
- oDMVersion
- originator
- sourceSystem
- sourceSystemVersion
- description
- study
- adminData
- referenceData
- clinicalData
- association
slot_usage:
  fileType:
    name: fileType
    description: Snapshot means that the document contains only the current state
      of the data and metadata it describes, and no transactional history. Transactional
      means that the document may contain more than one instance per data point. Query
      means the document contains only ClinicalData/Query elements.
    comments:
    - 'Required

      enum values: ( Snapshot | Transactional | Query)'
    domain_of:
    - ODMFileMetadata
    range: FileType
    required: true
  granularity:
    name: granularity
    description: Granularity is intended to give the sender a shorthand way to Describes
      the scope of information in the document, for certain common types of documents.
      All means the entire study; Metadata means the Study/MetaDataVersion element;
      AdminData and ReferenceData mean the corresponding elements; AllClinicalData
      means all of the ClinicalData collected for the study. SingleSite, means all
      of the Clinical Data for a single study site. SingleSubject means all of the
      Clinical Data for a single Subject.
    comments:
    - 'Optional

      enum values: ( All | Metadata | AdminData | ReferenceData | AllClinicalData
      | SingleSite | SingleSubject )'
    domain_of:
    - ODMFileMetadata
    range: Granularity
  context:
    name: context
    description: Indicates the intended usage of the ODM document. Archive - indicates
      that the file is intended to meet the requirements of an electronic record as
      defined in 21 CFR 11. Submission - indicates that the file is intended to be
      used for regulatory submission. Exchange - indicates that the file was generated
      to be imported into an ODM compliant system.
    comments:
    - 'Optional

      enum values: (Archive| Submission | Exchange)'
    domain_of:
    - Alias
    - FormalExpression
    - ODMFileMetadata
    range: Context
  fileOID:
    name: fileOID
    description: A unique identifier for this file.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - ODMFileMetadata
    range: oid
    required: true
  creationDateTime:
    name: creationDateTime
    description: Time of creation of the file containing the document.
    comments:
    - 'Required

      range: datetime'
    domain_of:
    - ODMFileMetadata
    range: datetime
    required: true
  priorFileOID:
    name: priorFileOID
    description: Reference to the previous file (if any) in a series.
    comments:
    - 'Optional

      range: oidref'
    domain_of:
    - ODMFileMetadata
    range: ODMFileMetadata
  asOfDateTime:
    name: asOfDateTime
    description: The date/time at which the source database was queried in order to
      create this document.
    comments:
    - 'Optional

      range: datetime'
    domain_of:
    - ODMFileMetadata
    range: datetime
  oDMVersion:
    name: oDMVersion
    description: The version of the ODM standard used.
    comments:
    - 'Required

      enum values: Pattern: 2.0(.(0|([1-9][0-9]*)))?(-([0-9a-zA-Z])+)*'
    domain_of:
    - ODMFileMetadata
    range: ODMVersion
  originator:
    name: originator
    description: The organization that generated the ODM file.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystem:
    name: sourceSystem
    description: The computer system or database management system that is the source
      of the information in this file.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystemVersion:
    name: sourceSystemVersion
    description: The version of the "SourceSystem" above.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  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
  study:
    name: study
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: Study
    inlined: true
    inlined_as_list: true
  adminData:
    name: adminData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: AdminData
    inlined: true
    inlined_as_list: true
  referenceData:
    name: referenceData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: ReferenceData
    inlined: true
    inlined_as_list: true
  clinicalData:
    name: clinicalData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: ClinicalData
    inlined: true
    inlined_as_list: true
  association:
    name: association
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: Association
    inlined: true
    inlined_as_list: true
class_uri: odm:ODM
tree_root: true

Induced

name: ODMFileMetadata
description: Root element for ODM Documents. The ODM element is the top-level (root)
  element of each ODM document.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ODM
rank: 1000
slot_usage:
  fileType:
    name: fileType
    description: Snapshot means that the document contains only the current state
      of the data and metadata it describes, and no transactional history. Transactional
      means that the document may contain more than one instance per data point. Query
      means the document contains only ClinicalData/Query elements.
    comments:
    - 'Required

      enum values: ( Snapshot | Transactional | Query)'
    domain_of:
    - ODMFileMetadata
    range: FileType
    required: true
  granularity:
    name: granularity
    description: Granularity is intended to give the sender a shorthand way to Describes
      the scope of information in the document, for certain common types of documents.
      All means the entire study; Metadata means the Study/MetaDataVersion element;
      AdminData and ReferenceData mean the corresponding elements; AllClinicalData
      means all of the ClinicalData collected for the study. SingleSite, means all
      of the Clinical Data for a single study site. SingleSubject means all of the
      Clinical Data for a single Subject.
    comments:
    - 'Optional

      enum values: ( All | Metadata | AdminData | ReferenceData | AllClinicalData
      | SingleSite | SingleSubject )'
    domain_of:
    - ODMFileMetadata
    range: Granularity
  context:
    name: context
    description: Indicates the intended usage of the ODM document. Archive - indicates
      that the file is intended to meet the requirements of an electronic record as
      defined in 21 CFR 11. Submission - indicates that the file is intended to be
      used for regulatory submission. Exchange - indicates that the file was generated
      to be imported into an ODM compliant system.
    comments:
    - 'Optional

      enum values: (Archive| Submission | Exchange)'
    domain_of:
    - Alias
    - FormalExpression
    - ODMFileMetadata
    range: Context
  fileOID:
    name: fileOID
    description: A unique identifier for this file.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - ODMFileMetadata
    range: oid
    required: true
  creationDateTime:
    name: creationDateTime
    description: Time of creation of the file containing the document.
    comments:
    - 'Required

      range: datetime'
    domain_of:
    - ODMFileMetadata
    range: datetime
    required: true
  priorFileOID:
    name: priorFileOID
    description: Reference to the previous file (if any) in a series.
    comments:
    - 'Optional

      range: oidref'
    domain_of:
    - ODMFileMetadata
    range: ODMFileMetadata
  asOfDateTime:
    name: asOfDateTime
    description: The date/time at which the source database was queried in order to
      create this document.
    comments:
    - 'Optional

      range: datetime'
    domain_of:
    - ODMFileMetadata
    range: datetime
  oDMVersion:
    name: oDMVersion
    description: The version of the ODM standard used.
    comments:
    - 'Required

      enum values: Pattern: 2.0(.(0|([1-9][0-9]*)))?(-([0-9a-zA-Z])+)*'
    domain_of:
    - ODMFileMetadata
    range: ODMVersion
  originator:
    name: originator
    description: The organization that generated the ODM file.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystem:
    name: sourceSystem
    description: The computer system or database management system that is the source
      of the information in this file.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystemVersion:
    name: sourceSystemVersion
    description: The version of the "SourceSystem" above.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ODMFileMetadata
    range: text
  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
  study:
    name: study
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: Study
    inlined: true
    inlined_as_list: true
  adminData:
    name: adminData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: AdminData
    inlined: true
    inlined_as_list: true
  referenceData:
    name: referenceData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: ReferenceData
    inlined: true
    inlined_as_list: true
  clinicalData:
    name: clinicalData
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: ClinicalData
    inlined: true
    inlined_as_list: true
  association:
    name: association
    multivalued: true
    domain_of:
    - ODMFileMetadata
    range: Association
    inlined: true
    inlined_as_list: true
attributes:
  fileType:
    name: fileType
    description: Snapshot means that the document contains only the current state
      of the data and metadata it describes, and no transactional history. Transactional
      means that the document may contain more than one instance per data point. Query
      means the document contains only ClinicalData/Query elements.
    comments:
    - 'Required

      enum values: ( Snapshot | Transactional | Query)'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: fileType
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: FileType
    required: true
  granularity:
    name: granularity
    description: Granularity is intended to give the sender a shorthand way to Describes
      the scope of information in the document, for certain common types of documents.
      All means the entire study; Metadata means the Study/MetaDataVersion element;
      AdminData and ReferenceData mean the corresponding elements; AllClinicalData
      means all of the ClinicalData collected for the study. SingleSite, means all
      of the Clinical Data for a single study site. SingleSubject means all of the
      Clinical Data for a single Subject.
    comments:
    - 'Optional

      enum values: ( All | Metadata | AdminData | ReferenceData | AllClinicalData
      | SingleSite | SingleSubject )'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: granularity
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: Granularity
  context:
    name: context
    description: Indicates the intended usage of the ODM document. Archive - indicates
      that the file is intended to meet the requirements of an electronic record as
      defined in 21 CFR 11. Submission - indicates that the file is intended to be
      used for regulatory submission. Exchange - indicates that the file was generated
      to be imported into an ODM compliant system.
    comments:
    - 'Optional

      enum values: (Archive| Submission | Exchange)'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: context
    owner: ODMFileMetadata
    domain_of:
    - Alias
    - FormalExpression
    - ODMFileMetadata
    range: Context
  fileOID:
    name: fileOID
    description: A unique identifier for this file.
    comments:
    - 'Required

      range: oid'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: fileOID
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: oid
    required: true
  creationDateTime:
    name: creationDateTime
    description: Time of creation of the file containing the document.
    comments:
    - 'Required

      range: datetime'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: creationDateTime
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: datetime
    required: true
  priorFileOID:
    name: priorFileOID
    description: Reference to the previous file (if any) in a series.
    comments:
    - 'Optional

      range: oidref'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: priorFileOID
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: ODMFileMetadata
  asOfDateTime:
    name: asOfDateTime
    description: The date/time at which the source database was queried in order to
      create this document.
    comments:
    - 'Optional

      range: datetime'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: asOfDateTime
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: datetime
  oDMVersion:
    name: oDMVersion
    description: The version of the ODM standard used.
    comments:
    - 'Required

      enum values: Pattern: 2.0(.(0|([1-9][0-9]*)))?(-([0-9a-zA-Z])+)*'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: oDMVersion
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: ODMVersion
  originator:
    name: originator
    description: The organization that generated the ODM file.
    comments:
    - 'Optional

      range: text'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: originator
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystem:
    name: sourceSystem
    description: The computer system or database management system that is the source
      of the information in this file.
    comments:
    - 'Optional

      range: text'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: sourceSystem
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: text
  sourceSystemVersion:
    name: sourceSystemVersion
    description: The version of the "SourceSystem" above.
    comments:
    - 'Optional

      range: text'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: sourceSystemVersion
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: text
  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: ODMFileMetadata
    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
  study:
    name: study
    description: 'Study reference: This element collects static structural information
      about an individual study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: study
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: Study
    inlined: true
    inlined_as_list: true
  adminData:
    name: adminData
    description: 'AdminData reference: Administrative information about users, locations,
      organizations, and electronic signatures.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: adminData
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: AdminData
    inlined: true
    inlined_as_list: true
  referenceData:
    name: referenceData
    description: 'ReferenceData reference: Reference data provides information on
      how to interpret clinical data. For example, reference data might include lab
      normal ranges. For a study that uses CDISC standards, reference data might include
      SDTM Trial Design datasets.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: referenceData
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: ReferenceData
    inlined: true
    inlined_as_list: true
  clinicalData:
    name: clinicalData
    description: 'ClinicalData reference: Clinical data for 1 or more subjects.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: clinicalData
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: ClinicalData
    inlined: true
    inlined_as_list: true
  association:
    name: association
    description: 'Association reference: An association permits an annotation to be
      placed on an ordered pair of entities rather than on just one. The first and
      second KeySets identify the start and end of the annotated "link.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: association
    owner: ODMFileMetadata
    domain_of:
    - ODMFileMetadata
    range: Association
    inlined: true
    inlined_as_list: true
class_uri: odm:ODM
tree_root: true