Class: SignatureDef

Provides Metadata for signatures included in the /ODM/ClinicalData.

URI: odm:SignatureDef

erDiagram
SignatureDef {
    oid OID  
    SignMethod methodology  
}
LegalReason {
    text content  
}
Meaning {
    text content  
}

SignatureDef ||--|o Meaning : "meaning"
SignatureDef ||--|o LegalReason : "legalReason"

Slots

Name Cardinality* and Range Description Inheritance
OID 1..1
oid		 Unique identifier. direct
methodology 0..1
SignMethod		 Defines the type of electronic signature, including the meaning as required b... direct
meaning 0..1
Meaning		 Meaning reference: A short name or description for this signature. It should ... direct
legalReason 0..1
LegalReason		 LegalReason reference: The responsibility statement associated with a signatu... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
AdminData signatureDef range SignatureDef
SignatureRef signatureOID range SignatureDef

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:SignatureDef
native odm:SignatureDef

LinkML Source

Direct

name: SignatureDef
description: Provides Metadata for signatures included in the /ODM/ClinicalData.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/SignatureDef
rank: 1000
slots:
- OID
- methodology
- meaning
- legalReason
slot_usage:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid

      Must be unique within a study.'
    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
  methodology:
    name: methodology
    description: Defines the type of electronic signature, including the meaning as
      required by 21 CFR Part 11 .
    comments:
    - 'Optional

      enum values: (Digital | Electronic)

      If the signature is digital, it is based on cryptography. Otherwise the signature
      is electronic.'
    domain_of:
    - SignatureDef
    range: SignMethod
  meaning:
    name: meaning
    domain_of:
    - SignatureDef
    range: Meaning
    maximum_cardinality: 1
  legalReason:
    name: legalReason
    domain_of:
    - SignatureDef
    range: LegalReason
    maximum_cardinality: 1
class_uri: odm:SignatureDef

Induced

name: SignatureDef
description: Provides Metadata for signatures included in the /ODM/ClinicalData.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/SignatureDef
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid

      Must be unique within a study.'
    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
  methodology:
    name: methodology
    description: Defines the type of electronic signature, including the meaning as
      required by 21 CFR Part 11 .
    comments:
    - 'Optional

      enum values: (Digital | Electronic)

      If the signature is digital, it is based on cryptography. Otherwise the signature
      is electronic.'
    domain_of:
    - SignatureDef
    range: SignMethod
  meaning:
    name: meaning
    domain_of:
    - SignatureDef
    range: Meaning
    maximum_cardinality: 1
  legalReason:
    name: legalReason
    domain_of:
    - SignatureDef
    range: LegalReason
    maximum_cardinality: 1
attributes:
  OID:
    name: OID
    description: Unique identifier.
    comments:
    - 'Required

      range: oid

      Must be unique within a study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: SignatureDef
    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
  methodology:
    name: methodology
    description: Defines the type of electronic signature, including the meaning as
      required by 21 CFR Part 11 .
    comments:
    - 'Optional

      enum values: (Digital | Electronic)

      If the signature is digital, it is based on cryptography. Otherwise the signature
      is electronic.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: methodology
    owner: SignatureDef
    domain_of:
    - SignatureDef
    range: SignMethod
  meaning:
    name: meaning
    description: 'Meaning reference: A short name or description for this signature.
      It should reflect the context of the signature and/or the text that appears
      when the signature is applied in the user interface.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: meaning
    owner: SignatureDef
    domain_of:
    - SignatureDef
    range: Meaning
    maximum_cardinality: 1
  legalReason:
    name: legalReason
    description: 'LegalReason reference: The responsibility statement associated with
      a signature (e.g., "The signer accepts responsibility for the accuracy of this
      data.").'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: legalReason
    owner: SignatureDef
    domain_of:
    - SignatureDef
    range: LegalReason
    maximum_cardinality: 1
class_uri: odm:SignatureDef