Key Guidelines for Usage

The StudyDataDictionaryVariable SHALL have the corresponding Code from the data-table associated with the specified variable as it’s Code. This provides a clear reference to the variable being described, and, when the code is properly used throughout transformed resources, it provides traceability to the origins of those transformed values.

Each variable SHALL describe, as completely as possible, everything a typical Data Dictionary entry might describe. The point of these is to aid researchers in knowing both what they should expect to find at any given column and how they may interpret the resulting information.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ObservationDefinition

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ObservationDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ObservationDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ObservationDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
category	Σ	0..*	CodeableConcept	Category of observation Binding: ObservationCategoryCodes (example): Codes for high level observation categories.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
identifier	Σ	0..*	Identifier	Business identifier for this ObservationDefinition instance
permittedDataType		0..*	code	Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period Binding: ObservationDataType (required): Permitted data type for observation value. Example General: CodeableConcept
multipleResultsAllowed		0..1	boolean	Multiple results allowed Example General: true
method		0..1	CodeableConcept	Method used to produce the observation Binding: ObservationMethods (example): Methods for simple observations.
preferredReportName		0..1	string	Preferred report name
quantitativeDetails		0..1	BackboneElement	Characteristics of quantitative results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
customaryUnit		0..1	CodeableConcept	Customary unit for quantitative results Binding: UCUMCodes (extensible): Codes identifying units of measure.
unit		0..1	CodeableConcept	SI unit for quantitative results Binding: UCUMCodes (extensible): Codes identifying units of measure.
conversionFactor		0..1	decimal	SI to Customary unit conversion factor
decimalPrecision		0..1	integer	Decimal precision of observation quantitative results
qualifiedInterval		0..*	BackboneElement	Qualified range for continuous and ordinal observation results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	code	reference | critical | absolute Binding: ObservationRangeCategory (required): Codes identifying the category of observation range. Example General: critical
range		0..1	Range	The interval itself, for continuous or ordinal observations
context		0..1	CodeableConcept	Range context qualifier Binding: ObservationReferenceRangeMeaningCodes (extensible): Code identifying the health context of a range.
appliesTo		0..*	CodeableConcept	Targetted population of the range Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
gender		0..1	code	male | female | other | unknown Binding: AdministrativeGender (required): The gender of a person used for administrative purposes. Example General: female
age		0..1	Range	Applicable age range, if relevant
gestationalAge		0..1	Range	Applicable gestational age range, if relevant
condition		0..1	string	Condition associated with the reference range
validCodedValueSet		0..1	Reference(ValueSet)	Value set of valid coded values for the observations conforming to this ObservationDefinition
normalCodedValueSet		0..1	Reference(ValueSet)	Value set of normal coded values for the observations conforming to this ObservationDefinition
abnormalCodedValueSet		0..1	Reference(ValueSet)	Value set of abnormal coded values for the observations conforming to this ObservationDefinition
criticalCodedValueSet		0..1	Reference(ValueSet)	Value set of critical coded values for the observations conforming to this ObservationDefinition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ObservationDefinition.category	example	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
ObservationDefinition.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
ObservationDefinition.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|4.3.0 from the FHIR Standard
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.quantitativeDetails.customaryUnit	extensible	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.quantitativeDetails.unit	extensible	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.qualifiedInterval.category	required	ObservationRangeCategory http://hl7.org/fhir/ValueSet/observation-range-category|4.3.0 from the FHIR Standard
ObservationDefinition.qualifiedInterval.context	extensible	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
ObservationDefinition.qualifiedInterval.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
ObservationDefinition.qualifiedInterval.gender	required	AdministrativeGender http://hl7.org/fhir/ValueSet/administrative-gender|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ObservationDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ObservationDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ObservationDefinition	A resource should have narrative for robust management : text.`div`.exists()
dom-r4b	warning	ObservationDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from ObservationDefinition

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ObservationDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ObservationDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ObservationDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ObservationDefinition		0..*	ObservationDefinition	Definition of an observation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
category	Σ	0..*	CodeableConcept	Category of observation Binding: ObservationCategoryCodes (example): Codes for high level observation categories.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
identifier	Σ	0..*	Identifier	Business identifier for this ObservationDefinition instance
permittedDataType		0..*	code	Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | SampledData | time | dateTime | Period Binding: ObservationDataType (required): Permitted data type for observation value. Example General: CodeableConcept
multipleResultsAllowed		0..1	boolean	Multiple results allowed Example General: true
method		0..1	CodeableConcept	Method used to produce the observation Binding: ObservationMethods (example): Methods for simple observations.
preferredReportName		0..1	string	Preferred report name
quantitativeDetails		0..1	BackboneElement	Characteristics of quantitative results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
customaryUnit		0..1	CodeableConcept	Customary unit for quantitative results Binding: UCUMCodes (extensible): Codes identifying units of measure.
unit		0..1	CodeableConcept	SI unit for quantitative results Binding: UCUMCodes (extensible): Codes identifying units of measure.
conversionFactor		0..1	decimal	SI to Customary unit conversion factor
decimalPrecision		0..1	integer	Decimal precision of observation quantitative results
qualifiedInterval		0..*	BackboneElement	Qualified range for continuous and ordinal observation results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	code	reference | critical | absolute Binding: ObservationRangeCategory (required): Codes identifying the category of observation range. Example General: critical
range		0..1	Range	The interval itself, for continuous or ordinal observations
context		0..1	CodeableConcept	Range context qualifier Binding: ObservationReferenceRangeMeaningCodes (extensible): Code identifying the health context of a range.
appliesTo		0..*	CodeableConcept	Targetted population of the range Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
gender		0..1	code	male | female | other | unknown Binding: AdministrativeGender (required): The gender of a person used for administrative purposes. Example General: female
age		0..1	Range	Applicable age range, if relevant
gestationalAge		0..1	Range	Applicable gestational age range, if relevant
condition		0..1	string	Condition associated with the reference range
validCodedValueSet		0..1	Reference(ValueSet)	Value set of valid coded values for the observations conforming to this ObservationDefinition
normalCodedValueSet		0..1	Reference(ValueSet)	Value set of normal coded values for the observations conforming to this ObservationDefinition
abnormalCodedValueSet		0..1	Reference(ValueSet)	Value set of abnormal coded values for the observations conforming to this ObservationDefinition
criticalCodedValueSet		0..1	Reference(ValueSet)	Value set of critical coded values for the observations conforming to this ObservationDefinition
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ObservationDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ObservationDefinition.category	example	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
ObservationDefinition.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
ObservationDefinition.permittedDataType	required	ObservationDataType http://hl7.org/fhir/ValueSet/permitted-data-type|4.3.0 from the FHIR Standard
ObservationDefinition.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
ObservationDefinition.quantitativeDetails.customaryUnit	extensible	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.quantitativeDetails.unit	extensible	UCUMCodes (a valid code from UCUM) http://hl7.org/fhir/ValueSet/ucum-units from the FHIR Standard
ObservationDefinition.qualifiedInterval.category	required	ObservationRangeCategory http://hl7.org/fhir/ValueSet/observation-range-category|4.3.0 from the FHIR Standard
ObservationDefinition.qualifiedInterval.context	extensible	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
ObservationDefinition.qualifiedInterval.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
ObservationDefinition.qualifiedInterval.gender	required	AdministrativeGender http://hl7.org/fhir/ValueSet/administrative-gender|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ObservationDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ObservationDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ObservationDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ObservationDefinition	A resource should have narrative for robust management : text.`div`.exists()
dom-r4b	warning	ObservationDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ObservationDefinition

Summary