Class: ReferenceData
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.
URI: odm:ReferenceData
erDiagram
ReferenceData {
}
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
}
ItemGroupData {
repeatKey itemGroupRepeatKey
TransactionType transactionType
positiveInteger itemGroupDataSeq
}
ItemData {
TransactionType transactionType
YesOnly isNull
}
Query {
oid OID
QuerySourceType source
text target
QueryType type
QueryStateType state
datetime lastUpdateDatetime
nameType name
}
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
}
MetaDataVersion {
oid OID
nameType name
}
Leaf {
oid ID
uriorcurie href
}
CommentDef {
oid OID
}
MethodDef {
oid OID
nameType name
MethodType type
}
ConditionDef {
oid OID
nameType name
}
CodeList {
oid OID
nameType name
CLDataType dataType
YesOnly isNonStandard
}
ItemDef {
oid OID
nameType name
DataType dataType
positiveInteger length
text displayFormat
text variableSet
}
StudyEventDef {
oid OID
nameType name
YesOrNo repeating
EventType type
text category
}
StudyEventGroupDef {
oid OID
nameType name
}
WorkflowDef {
oid OID
nameType name
}
Protocol {
}
WhereClauseDef {
oid OID
}
ValueListDef {
oid OID
}
SupplementalDoc {
}
AnnotatedCRF {
}
Standards {
}
Include {
uriorcurie href
}
Description {
}
Study {
oid OID
nameType studyName
nameType protocolName
nameType versionID
nameType versionName
nameType status
}
ReferenceData ||--|| Study : "studyOID"
ReferenceData ||--|| MetaDataVersion : "metaDataVersionOID"
ReferenceData ||--}o ItemGroupData : "itemGroupData"
ReferenceData ||--|o AuditRecord : "auditRecord"
ReferenceData ||--|o Signature : "signature"
ReferenceData ||--|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"
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"
ItemData ||--|| ItemDef : "itemOID"
ItemData ||--}o Value : "value"
ItemData ||--}o Query : "query"
ItemData ||--|o AuditRecord : "auditRecord"
ItemData ||--|o Signature : "signature"
ItemData ||--|o Annotation : "annotation"
Query ||--|o Value : "value"
Query ||--}o AuditRecord : "auditRecord"
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"
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"
MethodDef ||--|o CommentDef : "commentOID"
MethodDef ||--|o Description : "description"
MethodDef ||--|o MethodSignature : "methodSignature"
MethodDef ||--}o FormalExpression : "formalExpression"
MethodDef ||--}o Alias : "alias"
MethodDef ||--}o DocumentRef : "documentRef"
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"
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"
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"
WorkflowDef ||--|o Description : "description"
WorkflowDef ||--|o WorkflowStart : "workflowStart"
WorkflowDef ||--}o WorkflowEnd : "workflowEnd"
WorkflowDef ||--}o Transition : "transition"
WorkflowDef ||--}o Branching : "branching"
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"
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"
Description ||--}o TranslatedText : "translatedText"
Study ||--|o Description : "description"
Study ||--}o MetaDataVersion : "metaDataVersion"
Slots
Name | Cardinality* and Range | Description | Inheritance |
---|---|---|---|
studyOID | 1..1 Study |
References the Study that defines the metadata for this reference data. | direct |
metaDataVersionOID | 1..1 MetaDataVersion |
References the MetaDataVersion (within the above Study) for this reference da... | direct |
itemGroupData | 0..* ItemGroupData |
ItemGroupData reference: Clinical data corresponding to an ItemGroupRef defin... | 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 |
---|---|---|---|
ODMFileMetadata | referenceData | range | ReferenceData |
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:ReferenceData |
native | odm:ReferenceData |
LinkML Source
Direct
name: ReferenceData
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/ReferenceData
rank: 1000
slots:
- studyOID
- metaDataVersionOID
- itemGroupData
- auditRecord
- signature
- annotation
slot_usage:
studyOID:
name: studyOID
description: References the Study that defines the metadata for this reference
data.
comments:
- 'Required
range: oidref
Must match the OID of a Study element with a MetaDataVersion OID attribute that
matches the MetaDataVersionOID.'
domain_of:
- Include
- SourceItem
- AdminData
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: Study
required: true
metaDataVersionOID:
name: metaDataVersionOID
description: References the MetaDataVersion (within the above Study) for this
reference data. All metadata references (OIDs) occurring within this ReferenceData
element refer to definitions within the selected metadata version. Signature
elements nested within ReferenceData have no meaning, and should be ignored.
The TransactionType attribute behaves the same within ReferenceData as it does
within ClinicalData.
comments:
- 'Required
range: oidref
Must match the OID of a MetaDataVersion within a Study element with an OID attribute
that matches the StudyOID.'
domain_of:
- Include
- SourceItem
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: MetaDataVersion
required: true
itemGroupData:
name: itemGroupData
multivalued: true
domain_of:
- ReferenceData
- ClinicalData
- StudyEventData
- ItemGroupData
range: ItemGroupData
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:ReferenceData
Induced
name: ReferenceData
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/ReferenceData
rank: 1000
slot_usage:
studyOID:
name: studyOID
description: References the Study that defines the metadata for this reference
data.
comments:
- 'Required
range: oidref
Must match the OID of a Study element with a MetaDataVersion OID attribute that
matches the MetaDataVersionOID.'
domain_of:
- Include
- SourceItem
- AdminData
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: Study
required: true
metaDataVersionOID:
name: metaDataVersionOID
description: References the MetaDataVersion (within the above Study) for this
reference data. All metadata references (OIDs) occurring within this ReferenceData
element refer to definitions within the selected metadata version. Signature
elements nested within ReferenceData have no meaning, and should be ignored.
The TransactionType attribute behaves the same within ReferenceData as it does
within ClinicalData.
comments:
- 'Required
range: oidref
Must match the OID of a MetaDataVersion within a Study element with an OID attribute
that matches the StudyOID.'
domain_of:
- Include
- SourceItem
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: MetaDataVersion
required: true
itemGroupData:
name: itemGroupData
multivalued: true
domain_of:
- ReferenceData
- ClinicalData
- StudyEventData
- ItemGroupData
range: ItemGroupData
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:
studyOID:
name: studyOID
description: References the Study that defines the metadata for this reference
data.
comments:
- 'Required
range: oidref
Must match the OID of a Study element with a MetaDataVersion OID attribute that
matches the MetaDataVersionOID.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: studyOID
owner: ReferenceData
domain_of:
- Include
- SourceItem
- AdminData
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: Study
required: true
metaDataVersionOID:
name: metaDataVersionOID
description: References the MetaDataVersion (within the above Study) for this
reference data. All metadata references (OIDs) occurring within this ReferenceData
element refer to definitions within the selected metadata version. Signature
elements nested within ReferenceData have no meaning, and should be ignored.
The TransactionType attribute behaves the same within ReferenceData as it does
within ClinicalData.
comments:
- 'Required
range: oidref
Must match the OID of a MetaDataVersion within a Study element with an OID attribute
that matches the StudyOID.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: metaDataVersionOID
owner: ReferenceData
domain_of:
- Include
- SourceItem
- MetaDataVersionRef
- ReferenceData
- ClinicalData
- Association
- KeySet
range: MetaDataVersion
required: true
itemGroupData:
name: itemGroupData
description: 'ItemGroupData reference: Clinical data corresponding to an ItemGroupRef
defined in the active MetaDataVersion.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
multivalued: true
alias: itemGroupData
owner: ReferenceData
domain_of:
- ReferenceData
- ClinicalData
- StudyEventData
- ItemGroupData
range: ItemGroupData
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: ReferenceData
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: ReferenceData
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: ReferenceData
domain_of:
- ReferenceData
- ClinicalData
- SubjectData
- StudyEventData
- ItemGroupData
- ItemData
- Association
range: Annotation
maximum_cardinality: 1
class_uri: odm:ReferenceData