Class: Signature

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.

URI: odm:Signature

erDiagram
Signature {
    oid ID  
}
DateTimeStamp {
    datetime content  
}
SignatureRef {

}
SignatureDef {
    oid OID  
    SignMethod methodology  
}
LocationRef {

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

}
User {
    oid OID  
    UserType userType  
}

Signature ||--|o UserRef : "userRef"
Signature ||--|o LocationRef : "locationRef"
Signature ||--|o SignatureRef : "signatureRef"
Signature ||--|o DateTimeStamp : "dateTimeStamp"
SignatureRef ||--|| SignatureDef : "signatureOID"
SignatureDef ||--|o Meaning : "meaning"
SignatureDef ||--|o LegalReason : "legalReason"
LocationRef ||--|| 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"
UserRef ||--|| 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
ID 1..1
oid		 Unique identifier for the leaf that is referenced. direct
userRef 0..1
UserRef		 UserRef reference: A reference to information about a specific user of a clin... direct
locationRef 0..1
LocationRef		 LocationRef reference: A reference to the user's physical location. direct
signatureRef 0..1
SignatureRef		 SignatureRef reference: A reference to the signature meaning. direct
dateTimeStamp 0..1
DateTimeStamp		 DateTimeStamp reference: Date and time when an action was performed. direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
ReferenceData signature range Signature
ClinicalData signature range Signature
SubjectData signature range Signature
StudyEventData signature range Signature
ItemGroupData signature range Signature
ItemData signature range Signature

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:Signature
native odm:Signature

LinkML Source

Direct

name: Signature
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/Signature
rank: 1000
slots:
- ID
- userRef
- locationRef
- signatureRef
- dateTimeStamp
slot_usage:
  ID:
    name: ID
    identifier: true
    domain_of:
    - Leaf
    - Signature
    - Annotation
    range: oid
  userRef:
    name: userRef
    domain_of:
    - AuditRecord
    - Signature
    range: UserRef
    maximum_cardinality: 1
  locationRef:
    name: locationRef
    domain_of:
    - AuditRecord
    - Signature
    range: LocationRef
    maximum_cardinality: 1
  signatureRef:
    name: signatureRef
    domain_of:
    - Signature
    range: SignatureRef
    maximum_cardinality: 1
  dateTimeStamp:
    name: dateTimeStamp
    domain_of:
    - AuditRecord
    - Signature
    range: DateTimeStamp
    maximum_cardinality: 1
class_uri: odm:Signature

Induced

name: Signature
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/Signature
rank: 1000
slot_usage:
  ID:
    name: ID
    identifier: true
    domain_of:
    - Leaf
    - Signature
    - Annotation
    range: oid
  userRef:
    name: userRef
    domain_of:
    - AuditRecord
    - Signature
    range: UserRef
    maximum_cardinality: 1
  locationRef:
    name: locationRef
    domain_of:
    - AuditRecord
    - Signature
    range: LocationRef
    maximum_cardinality: 1
  signatureRef:
    name: signatureRef
    domain_of:
    - Signature
    range: SignatureRef
    maximum_cardinality: 1
  dateTimeStamp:
    name: dateTimeStamp
    domain_of:
    - AuditRecord
    - Signature
    range: DateTimeStamp
    maximum_cardinality: 1
attributes:
  ID:
    name: ID
    description: Unique identifier for the leaf that is referenced.
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: ID
    owner: Signature
    domain_of:
    - Leaf
    - Signature
    - Annotation
    range: oid
    required: true
  userRef:
    name: userRef
    description: 'UserRef reference: A reference to information about a specific user
      of a clinical data collection or data management system.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: userRef
    owner: Signature
    domain_of:
    - AuditRecord
    - Signature
    range: UserRef
    maximum_cardinality: 1
  locationRef:
    name: locationRef
    description: 'LocationRef reference: A reference to the user''s physical location.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: locationRef
    owner: Signature
    domain_of:
    - AuditRecord
    - Signature
    range: LocationRef
    maximum_cardinality: 1
  signatureRef:
    name: signatureRef
    description: 'SignatureRef reference: A reference to the signature meaning.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: signatureRef
    owner: Signature
    domain_of:
    - Signature
    range: SignatureRef
    maximum_cardinality: 1
  dateTimeStamp:
    name: dateTimeStamp
    description: 'DateTimeStamp reference: Date and time when an action was performed.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: dateTimeStamp
    owner: Signature
    domain_of:
    - AuditRecord
    - Signature
    range: DateTimeStamp
    maximum_cardinality: 1
class_uri: odm:Signature