Class: SubjectData

Clinical data for a single subject.

erDiagram
SubjectData {
    subjectKeyType subjectKey  
    TransactionType transactionType  
}
Annotation {
    positiveInteger seqNum  
    TransactionType transactionType  
    oid ID  
}
Flag {

}
Coding {
    text code  
    uriorcurie system  
    text systemName  
    text systemVersion  
    text label  
    uriorcurie href  
    uriorcurie ref  
    text commentOID  
}
Comment {
    CommentType sponsorOrSite  
}
Signature {
    oid ID  
}
DateTimeStamp {
    datetime content  
}
SignatureRef {

}
LocationRef {

}
UserRef {

}
AuditRecord {
    EditPointType editPoint  
    YesOrNo usedMethod  
}
SourceID {
    text content  
}
ReasonForChange {
    text content  
}
Query {
    oid OID  
    QuerySourceType source  
    text target  
    QueryType type  
    QueryStateType state  
    datetime lastUpdateDatetime  
    nameType name  
}
Value {
    positiveInteger seqNum  
    text content  
}
StudyEventData {
    repeatKey studyEventRepeatKey  
    TransactionType transactionType  
}
ItemGroupData {
    repeatKey itemGroupRepeatKey  
    TransactionType transactionType  
    positiveInteger itemGroupDataSeq  
}
StudyEventDef {
    oid OID  
    nameType name  
    YesOrNo repeating  
    EventType type  
    text category  
}
SiteRef {

}
Location {
    oid OID  
    nameType name  
    text role  
}
InvestigatorRef {

}
User {
    oid OID  
    UserType userType  
}

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"
Annotation ||--|o Comment : "comment"
Annotation ||--}o Coding : "coding"
Annotation ||--}o Flag : "flag"
Flag ||--|o FlagValue : "flagValue"
Flag ||--|o FlagType : "flagType"
Comment ||--}o TranslatedText : "translatedText"
Signature ||--|o UserRef : "userRef"
Signature ||--|o LocationRef : "locationRef"
Signature ||--|o SignatureRef : "signatureRef"
Signature ||--|o DateTimeStamp : "dateTimeStamp"
SignatureRef ||--|| SignatureDef : "signatureOID"
LocationRef ||--|| Location : "locationOID"
UserRef ||--|| User : "userOID"
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"
StudyEventData ||--|| StudyEventDef : "studyEventOID"
StudyEventData ||--}o ItemGroupData : "itemGroupData"
StudyEventData ||--}o Query : "query"
StudyEventData ||--|o AuditRecord : "auditRecord"
StudyEventData ||--|o Signature : "signature"
StudyEventData ||--|o Annotation : "annotation"
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"
StudyEventDef ||--|o CommentDef : "commentOID"
StudyEventDef ||--|o Description : "description"
StudyEventDef ||--}o ItemGroupRef : "itemGroupRef"
StudyEventDef ||--|o WorkflowRef : "workflowRef"
StudyEventDef ||--}o Coding : "coding"
StudyEventDef ||--}o Alias : "alias"
SiteRef ||--|| Location : "locationOID"
Location ||--|o Organization : "organizationOID"
Location ||--|o Description : "description"
Location ||--}o MetaDataVersionRef : "metaDataVersionRef"
Location ||--}o Address : "address"
Location ||--}o Telecom : "telecom"
Location ||--}o Query : "query"
InvestigatorRef ||--|| User : "userOID"
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"

Slots

Name	Cardinality* and Range	Description	Inheritance
subjectKey	1..1 subjectKeyType	Unique identifier for the Subject.	direct
transactionType	0..1 TransactionType	Identifies the transaction type when /ODM/@FileType is Transactional and ther...	direct
investigatorRef	0..1 InvestigatorRef	InvestigatorRef reference: Provides a reference to the user who created the S...	direct
siteRef	0..1 SiteRef	SiteRef reference: Provides a reference to the site that the SubjectData reco...	direct
studyEventData	0..* StudyEventData	StudyEventData reference: Clinical data for a study event (visit). The model ...	direct
query	0..* Query	Query reference: The Query element represents a request for clarification on ...	direct
auditRecord	0..1 AuditRecord	AuditRecord reference: An AuditRecord carries information pertaining to the c...	direct
signature	0..1 Signature	Signature reference: An electronic signature applies to a collection of clini...	direct
annotation	0..1 Annotation	Annotation reference: A general note about clinical data. If an annotation ha...	direct

* See LinkML documentation for cardinality definitions.

Usages

used by	used in	type	used
ClinicalData	subjectData	range	SubjectData

Identifier and Mapping Information

Schema Source

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

Mappings

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

LinkML Source

Direct

name: SubjectData
description: Clinical data for a single subject.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/SubjectData
rank: 1000
slots:
- subjectKey
- transactionType
- investigatorRef
- siteRef
- studyEventData
- query
- auditRecord
- signature
- annotation
slot_usage:
  subjectKey:
    name: subjectKey
    description: Unique identifier for the Subject.
    comments:
    - 'Required

      range: subjectKey

      For CDISC SDTM regulatory submission, the SubjectKey value should be the SDTM
      SUBJID variable value.'
    domain_of:
    - SubjectData
    - KeySet
    range: subjectKeyType
    required: true
  transactionType:
    name: transactionType
    description: Identifies the transaction type when /ODM/@FileType is Transactional
      and there is no child element.
    comments:
    - 'Conditional Required when contained within an ODM Transactional file and the
      SubjectData element has no child element content.

      enum values: (Insert | Update | Remove | Upsert | Context)

      When importing data from an ODM Snapshot file, the TransactionType attribute
      must not affect the processing of the SubjectData element.'
    domain_of:
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Annotation
    range: TransactionType
  investigatorRef:
    name: investigatorRef
    domain_of:
    - SubjectData
    range: InvestigatorRef
    maximum_cardinality: 1
  siteRef:
    name: siteRef
    domain_of:
    - SubjectData
    range: SiteRef
    maximum_cardinality: 1
  studyEventData:
    name: studyEventData
    multivalued: true
    domain_of:
    - SubjectData
    range: StudyEventData
    inlined: true
    inlined_as_list: true
  query:
    name: query
    multivalued: true
    domain_of:
    - Location
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Query
    inlined: true
    inlined_as_list: true
  auditRecord:
    name: auditRecord
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Query
    range: AuditRecord
    maximum_cardinality: 1
  signature:
    name: signature
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Signature
    maximum_cardinality: 1
  annotation:
    name: annotation
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Association
    range: Annotation
    maximum_cardinality: 1
class_uri: odm:SubjectData

Induced

name: SubjectData
description: Clinical data for a single subject.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/SubjectData
rank: 1000
slot_usage:
  subjectKey:
    name: subjectKey
    description: Unique identifier for the Subject.
    comments:
    - 'Required

      range: subjectKey

      For CDISC SDTM regulatory submission, the SubjectKey value should be the SDTM
      SUBJID variable value.'
    domain_of:
    - SubjectData
    - KeySet
    range: subjectKeyType
    required: true
  transactionType:
    name: transactionType
    description: Identifies the transaction type when /ODM/@FileType is Transactional
      and there is no child element.
    comments:
    - 'Conditional Required when contained within an ODM Transactional file and the
      SubjectData element has no child element content.

      enum values: (Insert | Update | Remove | Upsert | Context)

      When importing data from an ODM Snapshot file, the TransactionType attribute
      must not affect the processing of the SubjectData element.'
    domain_of:
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Annotation
    range: TransactionType
  investigatorRef:
    name: investigatorRef
    domain_of:
    - SubjectData
    range: InvestigatorRef
    maximum_cardinality: 1
  siteRef:
    name: siteRef
    domain_of:
    - SubjectData
    range: SiteRef
    maximum_cardinality: 1
  studyEventData:
    name: studyEventData
    multivalued: true
    domain_of:
    - SubjectData
    range: StudyEventData
    inlined: true
    inlined_as_list: true
  query:
    name: query
    multivalued: true
    domain_of:
    - Location
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Query
    inlined: true
    inlined_as_list: true
  auditRecord:
    name: auditRecord
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Query
    range: AuditRecord
    maximum_cardinality: 1
  signature:
    name: signature
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Signature
    maximum_cardinality: 1
  annotation:
    name: annotation
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Association
    range: Annotation
    maximum_cardinality: 1
attributes:
  subjectKey:
    name: subjectKey
    description: Unique identifier for the Subject.
    comments:
    - 'Required

      range: subjectKey

      For CDISC SDTM regulatory submission, the SubjectKey value should be the SDTM
      SUBJID variable value.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: subjectKey
    owner: SubjectData
    domain_of:
    - SubjectData
    - KeySet
    range: subjectKeyType
    required: true
  transactionType:
    name: transactionType
    description: Identifies the transaction type when /ODM/@FileType is Transactional
      and there is no child element.
    comments:
    - 'Conditional Required when contained within an ODM Transactional file and the
      SubjectData element has no child element content.

      enum values: (Insert | Update | Remove | Upsert | Context)

      When importing data from an ODM Snapshot file, the TransactionType attribute
      must not affect the processing of the SubjectData element.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: transactionType
    owner: SubjectData
    domain_of:
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Annotation
    range: TransactionType
  investigatorRef:
    name: investigatorRef
    description: 'InvestigatorRef reference: Provides a reference to the user who
      created the SubjectData record in the source system.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: investigatorRef
    owner: SubjectData
    domain_of:
    - SubjectData
    range: InvestigatorRef
    maximum_cardinality: 1
  siteRef:
    name: siteRef
    description: 'SiteRef reference: Provides a reference to the site that the SubjectData
      record is associated with in the source system.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: siteRef
    owner: SubjectData
    domain_of:
    - SubjectData
    range: SiteRef
    maximum_cardinality: 1
  studyEventData:
    name: studyEventData
    description: 'StudyEventData reference: Clinical data for a study event (visit).
      The model supports repeating study events (e.g., when the same set of information
      is collected for a series of patient visits).'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: studyEventData
    owner: SubjectData
    domain_of:
    - SubjectData
    range: StudyEventData
    inlined: true
    inlined_as_list: true
  query:
    name: query
    description: 'Query reference: The Query element represents a request for clarification
      on a data item collected for a clinical trial, specifically a request from a
      sponsor or sponsor’s representative to an investigator to resolve an error or
      inconsistency discovered during data review. Queries can be created manually
      by individuals such as site monitors or data managers or automatically by systems.
      The full text of the Query exists in the Value child element. The optional Name
      attribute provide the means to provide a short identifier that can be included
      in listing or user interfaces.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: query
    owner: SubjectData
    domain_of:
    - Location
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Query
    inlined: true
    inlined_as_list: true
  auditRecord:
    name: auditRecord
    description: 'AuditRecord reference: An AuditRecord carries information pertaining
      to the creation, deletion, or modification of clinical data. This information
      includes who performed that action, and where, when, and why that action was
      performed.AuditRecord information describes a change to clinical data, but is
      not itself clinical data. The value of some clinical data can always be changed
      by a subsequent transaction, but history cannot be changed, only added to.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: auditRecord
    owner: SubjectData
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Query
    range: AuditRecord
    maximum_cardinality: 1
  signature:
    name: signature
    description: 'Signature reference: An electronic signature applies to a collection
      of clinical data. This indicates that some user accepts legal responsibility
      for that data. See 21 CFR Part 11. The signature identifies the person signing,
      the location of signing, the signature meaning (via the referenced SignatureDef),
      the date and time of signing, and (in the case of a digital signature) an encrypted
      hash of the included data.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: signature
    owner: SubjectData
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    range: Signature
    maximum_cardinality: 1
  annotation:
    name: annotation
    description: 'Annotation reference: A general note about clinical data. If an
      annotation has both a comment and flags, the flags should be related to the
      comment.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: annotation
    owner: SubjectData
    domain_of:
    - ReferenceData
    - ClinicalData
    - SubjectData
    - StudyEventData
    - ItemGroupData
    - ItemData
    - Association
    range: Annotation
    maximum_cardinality: 1
class_uri: odm:SubjectData

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Class: SubjectData

Slots

Usages

See Also

Identifier and Mapping Information

Schema Source

Mappings

LinkML Source

Direct

Induced