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Biomedical Research and Regulation icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

Detailed Descriptions for the elements in the SubstanceDefinition resource.

SubstanceDefinition
Element Id SubstanceDefinition
Definition

The detailed description of a substance, typically at a level beyond what is used for prescribing.

Short Display The detailed description of a substance, typically at a level beyond what is used for prescribing
Cardinality 0..*
Type DomainResource
Summary false
SubstanceDefinition.identifier
Element Id SubstanceDefinition.identifier
Definition

Identifier by which this substance is known.

Short Display Identifier by which this substance is known
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary true
SubstanceDefinition.version
Element Id SubstanceDefinition.version
Definition

A business level version identifier of the substance.

Short Display A business level version identifier of the substance
Note This is a business versionId, not a resource version id (see discussion)
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.status
Element Id SubstanceDefinition.status
Definition

Status of substance within the catalogue e.g. active, retired.

Short Display Status of substance within the catalogue e.g. active, retired
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Summary true
SubstanceDefinition.classification
Element Id SubstanceDefinition.classification
Definition

A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).

Short Display A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
Cardinality 0..*
Type CodeableConcept
Summary true
SubstanceDefinition.domain
Element Id SubstanceDefinition.domain
Definition

If the substance applies to human or veterinary use.

Short Display If the substance applies to human or veterinary use
Cardinality 0..1
Terminology Binding Medicinal Product Domain (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.grade
Element Id SubstanceDefinition.grade
Definition

The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

Short Display The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Cardinality 0..*
Terminology Binding Substance Grade (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.description
Element Id SubstanceDefinition.description
Definition

Textual description of the substance.

Short Display Textual description of the substance
Cardinality 0..1
Type markdown
Summary true
SubstanceDefinition.informationSource
Element Id SubstanceDefinition.informationSource
Definition

Supporting literature.

Short Display Supporting literature
Cardinality 0..*
Type Reference(Citation)
Summary true
SubstanceDefinition.note
Element Id SubstanceDefinition.note
Definition

Textual comment about the substance's catalogue or registry record.

Short Display Textual comment about the substance's catalogue or registry record
Cardinality 0..*
Type Annotation
Summary true
SubstanceDefinition.manufacturer
Element Id SubstanceDefinition.manufacturer
Definition

The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.

Short Display The entity that creates, makes, produces or fabricates the substance
Cardinality 0..*
Type Reference(Organization)
Summary true
SubstanceDefinition.supplier
Element Id SubstanceDefinition.supplier
Definition

An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.

Short Display An entity that is the source for the substance. It may be different from the manufacturer
Cardinality 0..*
Type Reference(Organization)
Summary true
SubstanceDefinition.moiety
Element Id SubstanceDefinition.moiety
Definition

Moiety, for structural modifications.

Short Display Moiety, for structural modifications
Cardinality 0..*
Summary true
SubstanceDefinition.moiety.role
Element Id SubstanceDefinition.moiety.role
Definition

Role that the moiety is playing.

Short Display Role that the moiety is playing
Cardinality 0..1
Type CodeableConcept
Summary true
SubstanceDefinition.moiety.identifier
Element Id SubstanceDefinition.moiety.identifier
Definition

Identifier by which this moiety substance is known.

Short Display Identifier by which this moiety substance is known
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..1
Type Identifier
Summary true
SubstanceDefinition.moiety.name
Element Id SubstanceDefinition.moiety.name
Definition

Textual name for this moiety substance.

Short Display Textual name for this moiety substance
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.moiety.stereochemistry
Element Id SubstanceDefinition.moiety.stereochemistry
Definition

Stereochemistry type.

Short Display Stereochemistry type
Cardinality 0..1
Terminology Binding Stereochemistry (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.moiety.opticalActivity
Element Id SubstanceDefinition.moiety.opticalActivity
Definition

Optical activity type.

Short Display Optical activity type
Cardinality 0..1
Terminology Binding Optical Activity (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.moiety.molecularFormula
Element Id SubstanceDefinition.moiety.molecularFormula
Definition

Molecular formula for this moiety of this substance, typically using the Hill system.

Short Display Molecular formula for this moiety (e.g. with the Hill system)
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.moiety.amount[x]
Element Id SubstanceDefinition.moiety.amount[x]
Definition

Quantitative value for this moiety.

Short Display Quantitative value for this moiety
Cardinality 0..1
Type Quantity|string
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
SubstanceDefinition.moiety.measurementType
Element Id SubstanceDefinition.moiety.measurementType
Definition

The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.

Short Display The measurement type of the quantitative value
Cardinality 0..1
Terminology Binding Substance Amount Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.characterization
Element Id SubstanceDefinition.characterization
Definition

General specifications for this substance.

Short Display General specifications for this substance
Cardinality 0..*
Summary true
SubstanceDefinition.characterization.technique
Element Id SubstanceDefinition.characterization.technique
Definition

The method used to elucidate the characterization of the drug substance. Example: HPLC.

Short Display The method used to find the characterization e.g. HPLC
Cardinality 0..1
Terminology Binding Structure Technique (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.characterization.form
Element Id SubstanceDefinition.characterization.form
Definition

Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.

Short Display Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Cardinality 0..1
Terminology Binding Substance Form (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.characterization.description
Element Id SubstanceDefinition.characterization.description
Definition

The description or justification in support of the interpretation of the data file.

Short Display The description or justification in support of the interpretation of the data file
Cardinality 0..1
Type markdown
Summary true
SubstanceDefinition.characterization.file
Element Id SubstanceDefinition.characterization.file
Definition

The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

Short Display The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
Cardinality 0..*
Type Attachment
Summary true
SubstanceDefinition.property
Element Id SubstanceDefinition.property
Definition

General specifications for this substance.

Short Display General specifications for this substance
Cardinality 0..*
Summary true
SubstanceDefinition.property.type
Element Id SubstanceDefinition.property.type
Definition

A code expressing the type of property.

Short Display A code expressing the type of property
Cardinality 1..1
Terminology Binding Product Characteristic (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.property.value[x]
Element Id SubstanceDefinition.property.value[x]
Definition

A value for the property.

Short Display A value for the property
Cardinality 0..1
Type CodeableConcept|Quantity|date|boolean|Attachment
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
SubstanceDefinition.referenceInformation
Element Id SubstanceDefinition.referenceInformation
Definition

General information detailing this substance.

Short Display General information detailing this substance
Cardinality 0..1
Type Reference(SubstanceReferenceInformation)
Summary true
SubstanceDefinition.molecularWeight
Element Id SubstanceDefinition.molecularWeight
Definition

The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.

Short Display The average mass of a molecule of a compound
Cardinality 0..*
Summary true
SubstanceDefinition.molecularWeight.method
Element Id SubstanceDefinition.molecularWeight.method
Definition

The method by which the molecular weight was determined.

Short Display The method by which the weight was determined
Cardinality 0..1
Terminology Binding Weight Method (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.molecularWeight.type
Element Id SubstanceDefinition.molecularWeight.type
Definition

Type of molecular weight such as exact, average (also known as. number average), weight average.

Short Display Type of molecular weight e.g. exact, average, weight average
Cardinality 0..1
Terminology Binding Weight Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.molecularWeight.amount
Element Id SubstanceDefinition.molecularWeight.amount
Definition

Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.

Short Display Used to capture quantitative values for a variety of elements
Cardinality 1..1
Type Quantity
Summary true
SubstanceDefinition.structure
Element Id SubstanceDefinition.structure
Definition

Structural information.

Short Display Structural information
Cardinality 0..1
Summary true
SubstanceDefinition.structure.stereochemistry
Element Id SubstanceDefinition.structure.stereochemistry
Definition

Stereochemistry type.

Short Display Stereochemistry type
Cardinality 0..1
Terminology Binding Stereochemistry (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.structure.opticalActivity
Element Id SubstanceDefinition.structure.opticalActivity
Definition

Optical activity type.

Short Display Optical activity type
Cardinality 0..1
Terminology Binding Optical Activity (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.structure.molecularFormula
Element Id SubstanceDefinition.structure.molecularFormula
Definition

An expression which states the number and type of atoms present in a molecule of a substance.

Short Display An expression which states the number and type of atoms present in a molecule of a substance
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.structure.molecularFormulaByMoiety
Element Id SubstanceDefinition.structure.molecularFormulaByMoiety
Definition

Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.

Short Display Specified per moiety according to the Hill system
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.structure.molecularWeight
Element Id SubstanceDefinition.structure.molecularWeight
Definition

The molecular weight or weight range (for proteins, polymers or nucleic acids).

Short Display The molecular weight or weight range
Cardinality 0..1
Type See SubstanceDefinition.molecularWeight
Summary true
SubstanceDefinition.structure.technique
Element Id SubstanceDefinition.structure.technique
Definition

The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.

Short Display The method used to find the structure e.g. X-ray, NMR
Cardinality 0..*
Terminology Binding Structure Technique (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.structure.sourceDocument
Element Id SubstanceDefinition.structure.sourceDocument
Definition

The source of information about the structure.

Short Display Source of information for the structure
Cardinality 0..*
Type Reference(DocumentReference)
Summary true
SubstanceDefinition.structure.representation
Element Id SubstanceDefinition.structure.representation
Definition

A depiction of the structure of the substance.

Short Display A depiction of the structure of the substance
Cardinality 0..*
Summary true
SubstanceDefinition.structure.representation.type
Element Id SubstanceDefinition.structure.representation.type
Definition

The kind of structural representation (e.g. full, partial).

Short Display The kind of structural representation (e.g. full, partial)
Cardinality 0..1
Terminology Binding Substance Representation Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.structure.representation.representation
Element Id SubstanceDefinition.structure.representation.representation
Definition

The structural representation as a text string in a standard format.

Short Display The structural representation as a text string in a standard format
Cardinality 0..1
Type string
Summary true
SubstanceDefinition.structure.representation.format
Element Id SubstanceDefinition.structure.representation.format
Definition

The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

Short Display The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Cardinality 0..1
Terminology Binding Substance Representation Format (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.structure.representation.document
Element Id SubstanceDefinition.structure.representation.document
Definition

An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

Short Display An attachment with the structural representation e.g. a structure graphic or AnIML file
Cardinality 0..1
Type Reference(DocumentReference)
Summary true
SubstanceDefinition.code
Element Id SubstanceDefinition.code
Definition

Codes associated with the substance.

Short Display Codes associated with the substance
Cardinality 0..*
Summary true
SubstanceDefinition.code.code
Element Id SubstanceDefinition.code.code
Definition

The specific code.

Short Display The specific code
Cardinality 0..1
Type CodeableConcept
Summary true
SubstanceDefinition.code.status
Element Id SubstanceDefinition.code.status
Definition

Status of the code assignment, for example 'provisional', 'approved'.

Short Display Status of the code assignment, for example 'provisional', 'approved'
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Summary true
SubstanceDefinition.code.statusDate
Element Id SubstanceDefinition.code.statusDate
Definition

The date at which the code status was changed as part of the terminology maintenance.

Short Display The date at which the code status was changed
Cardinality 0..1
Type dateTime
Summary true
SubstanceDefinition.code.note
Element Id SubstanceDefinition.code.note
Definition

Any comment can be provided in this field, if necessary.

Short Display Any comment can be provided in this field
Cardinality 0..*
Type Annotation
Summary true
SubstanceDefinition.code.source
Element Id SubstanceDefinition.code.source
Definition

Supporting literature.

Short Display Supporting literature
Cardinality 0..*
Type Reference(DocumentReference)
Summary true
SubstanceDefinition.name
Element Id SubstanceDefinition.name
Definition

Names applicable to this substance.

Short Display Names applicable to this substance
Cardinality 0..*
Summary true
SubstanceDefinition.name.name
Element Id SubstanceDefinition.name.name
Definition

The actual name.

Short Display The actual name
Cardinality 1..1
Type string
Summary true
SubstanceDefinition.name.type
Element Id SubstanceDefinition.name.type
Definition

Name type, for example 'systematic', 'scientific, 'brand'.

Short Display Name type e.g. 'systematic', 'scientific, 'brand'
Cardinality 0..1
Terminology Binding Substance Name Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.name.status
Element Id SubstanceDefinition.name.status
Definition

The status of the name, for example 'current', 'proposed'.

Short Display The status of the name e.g. 'current', 'proposed'
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Summary true
SubstanceDefinition.name.preferred
Element Id SubstanceDefinition.name.preferred
Definition

If this is the preferred name for this substance.

Short Display If this is the preferred name for this substance
Cardinality 0..1
Type boolean
Meaning if Missing If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Summary true
SubstanceDefinition.name.language
Element Id SubstanceDefinition.name.language
Definition

Human language that the name is written in.

Short Display Human language that the name is written in
Cardinality 0..*
Terminology Binding All Languages (Required)
Additional BindingsPurpose
Common Languages Starter Set
Type CodeableConcept
Summary true
SubstanceDefinition.name.domain
Element Id SubstanceDefinition.name.domain
Definition

The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

Short Display The use context of this name e.g. as an active ingredient or as a food colour additive
Cardinality 0..*
Terminology Binding Substance Name Domain (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.name.jurisdiction
Element Id SubstanceDefinition.name.jurisdiction
Definition

The jurisdiction where this name applies.

Short Display The jurisdiction where this name applies
Cardinality 0..*
Terminology Binding Jurisdiction ValueSet (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.name.synonym
Element Id SubstanceDefinition.name.synonym
Definition

A synonym of this particular name, by which the substance is also known.

Short Display A synonym of this particular name, by which the substance is also known
Cardinality 0..*
Type See SubstanceDefinition.name
Summary true
SubstanceDefinition.name.translation
Element Id SubstanceDefinition.name.translation
Definition

A translation for this name into another human language.

Short Display A translation for this name into another human language
Cardinality 0..*
Type See SubstanceDefinition.name
Summary true
SubstanceDefinition.name.official
Element Id SubstanceDefinition.name.official
Definition

Details of the official nature of this name.

Short Display Details of the official nature of this name
Cardinality 0..*
Summary true
SubstanceDefinition.name.official.authority
Element Id SubstanceDefinition.name.official.authority
Definition

Which authority uses this official name.

Short Display Which authority uses this official name
Cardinality 0..1
Terminology Binding Substance Name Authority (Preferred)
Type CodeableConcept
Summary true
SubstanceDefinition.name.official.status
Element Id SubstanceDefinition.name.official.status
Definition

The status of the official name, for example 'draft', 'active', 'retired'.

Short Display The status of the official name, for example 'draft', 'active'
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Summary true
SubstanceDefinition.name.official.date
Element Id SubstanceDefinition.name.official.date
Definition

Date of the official name change.

Short Display Date of official name change
Cardinality 0..1
Type dateTime
Summary true
SubstanceDefinition.name.source
Element Id SubstanceDefinition.name.source
Definition

Supporting literature.

Short Display Supporting literature
Cardinality 0..*
Type Reference(DocumentReference)
Summary true
SubstanceDefinition.relationship
Element Id SubstanceDefinition.relationship
Definition

A link between this substance and another, with details of the relationship.

Short Display A link between this substance and another
Cardinality 0..*
Summary true
SubstanceDefinition.relationship.substanceDefinition[x]
Element Id SubstanceDefinition.relationship.substanceDefinition[x]
Definition

A pointer to another substance, as a resource or just a representational code.

Short Display A pointer to another substance, as a resource or a representational code
Cardinality 0..1
Type Reference(SubstanceDefinition)|CodeableConcept
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
SubstanceDefinition.relationship.type
Element Id SubstanceDefinition.relationship.type
Definition

For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

Short Display For example "salt to parent", "active moiety"
Cardinality 1..1
Terminology Binding Substance Relationship Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.relationship.isDefining
Element Id SubstanceDefinition.relationship.isDefining
Definition

For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.

Short Display For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
Cardinality 0..1
Type boolean
Meaning if Missing If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
Summary true
SubstanceDefinition.relationship.amount[x]
Element Id SubstanceDefinition.relationship.amount[x]
Definition

A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.

Short Display A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
Cardinality 0..1
Type Quantity|Ratio|string
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
SubstanceDefinition.relationship.ratioHighLimitAmount
Element Id SubstanceDefinition.relationship.ratioHighLimitAmount
Definition

For use when the numeric has an uncertain range.

Short Display For use when the numeric has an uncertain range
Cardinality 0..1
Type Ratio
Summary true
SubstanceDefinition.relationship.comparator
Element Id SubstanceDefinition.relationship.comparator
Definition

An operator for the amount, for example "average", "approximately", "less than".

Short Display An operator for the amount, for example "average", "approximately", "less than"
Cardinality 0..1
Terminology Binding Substance Amount Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.relationship.source
Element Id SubstanceDefinition.relationship.source
Definition

Supporting literature.

Short Display Supporting literature
Cardinality 0..*
Type Reference(DocumentReference)
Summary true
SubstanceDefinition.nucleicAcid
Element Id SubstanceDefinition.nucleicAcid
Definition

Data items specific to nucleic acids.

Short Display Data items specific to nucleic acids
Cardinality 0..1
Type Reference(SubstanceNucleicAcid)
Summary true
SubstanceDefinition.polymer
Element Id SubstanceDefinition.polymer
Definition

Data items specific to polymers.

Short Display Data items specific to polymers
Cardinality 0..1
Type Reference(SubstancePolymer)
Summary true
SubstanceDefinition.protein
Element Id SubstanceDefinition.protein
Definition

Data items specific to proteins.

Short Display Data items specific to proteins
Cardinality 0..1
Type Reference(SubstanceProtein)
Summary true
SubstanceDefinition.sourceMaterial
Element Id SubstanceDefinition.sourceMaterial
Definition

Material or taxonomic/anatomical source for the substance.

Short Display Material or taxonomic/anatomical source
Cardinality 0..1
Summary true
SubstanceDefinition.sourceMaterial.type
Element Id SubstanceDefinition.sourceMaterial.type
Definition

A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.

Short Display Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Cardinality 0..1
Terminology Binding Source Material Type (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.sourceMaterial.genus
Element Id SubstanceDefinition.sourceMaterial.genus
Definition

The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

Short Display The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Cardinality 0..1
Terminology Binding Source Material Genus (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.sourceMaterial.species
Element Id SubstanceDefinition.sourceMaterial.species
Definition

The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

Short Display The species of an organism e.g. the Latin epithet of the species of the plant/animal
Cardinality 0..1
Terminology Binding Source Material Species (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.sourceMaterial.part
Element Id SubstanceDefinition.sourceMaterial.part
Definition

An anatomical origin of the source material within an organism.

Short Display An anatomical origin of the source material within an organism
Cardinality 0..1
Terminology Binding Source Material Part (Example)
Type CodeableConcept
Summary true
SubstanceDefinition.sourceMaterial.countryOfOrigin
Element Id SubstanceDefinition.sourceMaterial.countryOfOrigin
Definition

The country or countries where the material is harvested.

Short Display The country or countries where the material is harvested
Cardinality 0..*
Terminology Binding Country ValueSet (Required)
Type CodeableConcept
Summary true