Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: Polymorphic Form

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form Version: 1.0.0-ballot
Active as of 2024-04-04 Computable Name: PolymorphicForm
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.28

Alternate structure present in the drug substance

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition SubstanceDefinition
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier optional user designated identifier
... structure S 0..1 BackboneElement Structural information
.... molecularFormula S 0..1 string Molecular Formula
.... technique S 0..1 CodeableConcept Substance Characterization Technique
..... text S 1..1 string Plain text representation of the concept
.... representation S 1..* BackboneElement A depiction of the structure of the substance
..... representation S 0..1 string Structural Representation
..... format S 0..1 CodeableConcept Structural Representation Type
...... coding 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
..... document S 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
.... code
..... coding 0..* Coding UNII
...... system 0..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
... Slices for name SC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... preferred S 0..1 boolean True when the name type is Substance Name
.... name:sub S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string Generic Name
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:gsrs S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string GSRS Preferred Term
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:isbt S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string ISBT-128 DIN
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred S 0..1 boolean If this is the preferred name for this substance

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier optional user designated identifier
... structure SΣ 0..1 BackboneElement Structural information
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... molecularFormula SΣ 0..1 string Molecular Formula
.... technique SΣ 0..1 CodeableConcept Substance Characterization Technique
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


..... text SΣ 1..1 string Plain text representation of the concept
.... representation SΣ 1..* BackboneElement A depiction of the structure of the substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... representation SΣ 0..1 string Structural Representation
..... format SΣ 0..1 CodeableConcept Structural Representation Type
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
..... document SΣ 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 0..1 BackboneElement Codes associated with the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... preferred SΣ 0..1 boolean True when the name type is Substance Name
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier optional user designated identifier
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept 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
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer Σ 0..* Reference(Organization) The entity that creates, makes, produces or fabricates the substance
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... 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
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... 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
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment 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
... property Σ 0..* BackboneElement General specifications for this substance
.... 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
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... 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
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure SΣ 0..1 BackboneElement Structural information
.... 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
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula SΣ 0..1 string Molecular Formula
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique SΣ 0..1 CodeableConcept Substance Characterization Technique
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
..... text SΣ 1..1 string Plain text representation of the concept
.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation SΣ 1..* BackboneElement A depiction of the structure of the substance
..... 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
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation SΣ 0..1 string Structural Representation
..... format SΣ 0..1 CodeableConcept Structural Representation Type
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
...... text Σ 0..1 string Plain text representation of the concept
..... document SΣ 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 0..1 BackboneElement Codes associated with the substance
.... 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
.... code Σ 0..1 CodeableConcept The specific code
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding UNII
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... 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
..... name Σ 1..1 string The actual name
..... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean True when the name type is Substance Name
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... 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
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source
.... 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
.... type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: CountryValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
SubstanceDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:sub.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:sub.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:sub.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:sub.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:sub.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:gsrs.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:isbt.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:isbt.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:isbt.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:isbt.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 1 element(9 nested mandatory elements)
Must-Support: 28 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of SubstanceDefinition.name (Closed)

Differential View

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition SubstanceDefinition
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier optional user designated identifier
... structure S 0..1 BackboneElement Structural information
.... molecularFormula S 0..1 string Molecular Formula
.... technique S 0..1 CodeableConcept Substance Characterization Technique
..... text S 1..1 string Plain text representation of the concept
.... representation S 1..* BackboneElement A depiction of the structure of the substance
..... representation S 0..1 string Structural Representation
..... format S 0..1 CodeableConcept Structural Representation Type
...... coding 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
..... document S 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
.... code
..... coding 0..* Coding UNII
...... system 0..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
... Slices for name SC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... preferred S 0..1 boolean True when the name type is Substance Name
.... name:sub S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string Generic Name
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:gsrs S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string GSRS Preferred Term
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred S 0..1 boolean If this is the preferred name for this substance
.... name:isbt S 0..1 BackboneElement Names applicable to this substance
..... name S 1..1 string ISBT-128 DIN
..... type S 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
...... coding S 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred S 0..1 boolean If this is the preferred name for this substance

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier optional user designated identifier
... structure SΣ 0..1 BackboneElement Structural information
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... molecularFormula SΣ 0..1 string Molecular Formula
.... technique SΣ 0..1 CodeableConcept Substance Characterization Technique
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


..... text SΣ 1..1 string Plain text representation of the concept
.... representation SΣ 1..* BackboneElement A depiction of the structure of the substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... representation SΣ 0..1 string Structural Representation
..... format SΣ 0..1 CodeableConcept Structural Representation Type
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
..... document SΣ 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 0..1 BackboneElement Codes associated with the substance
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name Σ 1..1 string The actual name
..... preferred SΣ 0..1 boolean True when the name type is Substance Name
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
..... preferred SΣ 0..1 boolean If this is the preferred name for this substance

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier optional user designated identifier
... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... classification Σ 0..* CodeableConcept 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
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

... grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies


... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature
... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record
... manufacturer Σ 0..* Reference(Organization) The entity that creates, makes, produces or fabricates the substance
... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ 0..* BackboneElement Moiety, for structural modifications
.... 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
.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

... characterization Σ 0..* BackboneElement General specifications for this substance
.... 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
.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 0..* Attachment 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
... property Σ 0..* BackboneElement General specifications for this substance
.... 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
.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound
.... 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
.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure SΣ 0..1 BackboneElement Structural information
.... 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
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

.... molecularFormula SΣ 0..1 string Molecular Formula
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 See molecularWeight (SubstanceDefinition) The molecular weight or weight range
.... technique SΣ 0..1 CodeableConcept Substance Characterization Technique
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
..... text SΣ 1..1 string Plain text representation of the concept
.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure
.... representation SΣ 1..* BackboneElement A depiction of the structure of the substance
..... 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
..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

..... representation SΣ 0..1 string Structural Representation
..... format SΣ 0..1 CodeableConcept Structural Representation Type
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
Binding: Chemical Structure Data File Type Terminology (required)
...... text Σ 0..1 string Plain text representation of the concept
..... document SΣ 0..1 Reference(Document Reference Attachment) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code SΣ 0..1 BackboneElement Codes associated with the substance
.... 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
.... code Σ 0..1 CodeableConcept The specific code
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding UNII
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: http://fdasis.nlm.nih.gov
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field
.... source Σ 0..* Reference(DocumentReference) Supporting literature
... Slices for name SΣC 1..* BackboneElement Substance Name
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
.... name:All Slices Content/Rules for all slices
..... 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
..... name Σ 1..1 string The actual name
..... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean True when the name type is Substance Name
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:sub SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string Generic Name
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C97054
....... display 1..1 string Representation defined by the system
Fixed Value: Generic Name
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:gsrs SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string GSRS Preferred Term
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C203355
....... display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred Term
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
.... name:isbt SΣ 0..1 BackboneElement Names applicable to this substance
..... 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
..... name SΣ 1..1 string ISBT-128 DIN
..... type SΣ 1..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding SΣ 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C95517
....... display 1..1 string Representation defined by the system
Fixed Value: ISBT-128 DIN
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... preferred SΣ 0..1 boolean If this is the preferred name for this substance
..... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

..... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.


..... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes


..... synonym Σ 0..* See name (SubstanceDefinition) A synonym of this particular name, by which the substance is also known
..... translation Σ 0..* See name (SubstanceDefinition) A translation for this name into another human language
..... official Σ 0..* BackboneElement Details of the official nature of this name
...... 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
...... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

...... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

...... date Σ 0..1 dateTime Date of official name change
..... source Σ 0..* Reference(DocumentReference) Supporting literature
... relationship Σ 0..* BackboneElement A link between this substance and another
.... 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
.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

.... isDefining Σ 0..1 boolean For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ 0..1 A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantity Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

.... source Σ 0..* Reference(DocumentReference) Supporting literature
... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source
.... 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
.... type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: CountryValueSet (required): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
SubstanceDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
SubstanceDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
SubstanceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
SubstanceDefinition.gradeexampleSubstanceGrade
http://hl7.org/fhir/ValueSet/substance-grade
from the FHIR Standard
SubstanceDefinition.moiety.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.moiety.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.moiety.measurementTypeexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.characterization.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.characterization.formexampleSubstanceForm
http://hl7.org/fhir/ValueSet/substance-form
from the FHIR Standard
SubstanceDefinition.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard
SubstanceDefinition.molecularWeight.methodexampleWeightMethod
http://hl7.org/fhir/ValueSet/substance-weight-method
from the FHIR Standard
SubstanceDefinition.molecularWeight.typeexampleWeightType
http://hl7.org/fhir/ValueSet/substance-weight-type
from the FHIR Standard
SubstanceDefinition.structure.stereochemistryexampleStereochemistry
http://hl7.org/fhir/ValueSet/substance-stereochemistry
from the FHIR Standard
SubstanceDefinition.structure.opticalActivityexampleOpticalActivity
http://hl7.org/fhir/ValueSet/substance-optical-activity
from the FHIR Standard
SubstanceDefinition.structure.techniqueexampleStructureTechnique
http://hl7.org/fhir/ValueSet/substance-structure-technique
from the FHIR Standard
SubstanceDefinition.structure.representation.typeexampleSubstanceRepresentationType
http://hl7.org/fhir/ValueSet/substance-representation-type
from the FHIR Standard
SubstanceDefinition.structure.representation.formatexampleSubstanceRepresentationFormat
http://hl7.org/fhir/ValueSet/substance-representation-format
from the FHIR Standard
SubstanceDefinition.structure.representation.format.codingrequiredPqcmcChemicalStructureDataFileTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology
from this IG
SubstanceDefinition.code.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:sub.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:sub.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:sub.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:sub.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:sub.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:sub.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:gsrs.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:gsrs.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:gsrs.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:gsrs.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:gsrs.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.typeexampleSubstanceNameType
http://hl7.org/fhir/ValueSet/substance-name-type
from the FHIR Standard
SubstanceDefinition.name:isbt.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.name:isbt.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
SubstanceDefinition.name:isbt.domainexampleSubstanceNameDomain
http://hl7.org/fhir/ValueSet/substance-name-domain
from the FHIR Standard
SubstanceDefinition.name:isbt.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
SubstanceDefinition.name:isbt.official.authoritypreferredSubstanceNameAuthority
http://hl7.org/fhir/ValueSet/substance-name-authority
from the FHIR Standard
SubstanceDefinition.name:isbt.official.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
SubstanceDefinition.relationship.typeexampleSubstanceRelationshipType
http://hl7.org/fhir/ValueSet/substance-relationship-type
from the FHIR Standard
SubstanceDefinition.relationship.comparatorexampleSubstanceAmountType
http://hl7.org/fhir/ValueSet/substance-amount-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.typeexampleSourceMaterialType
http://hl7.org/fhir/ValueSet/substance-source-material-type
from the FHIR Standard
SubstanceDefinition.sourceMaterial.genusexampleSourceMaterialGenus
http://hl7.org/fhir/ValueSet/substance-source-material-genus
from the FHIR Standard
SubstanceDefinition.sourceMaterial.speciesexampleSourceMaterialSpecies
http://hl7.org/fhir/ValueSet/substance-source-material-species
from the FHIR Standard
SubstanceDefinition.sourceMaterial.partexampleSourceMaterialPart
http://hl7.org/fhir/ValueSet/substance-source-material-part
from the FHIR Standard
SubstanceDefinition.sourceMaterial.countryOfOriginrequiredCountryValueSet
http://hl7.org/fhir/ValueSet/country|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-name-preferrederrorSubstanceDefinition.nameName.preferred: at most one = true
: select(preferred = true).count() < 2
dom-2errorSubstanceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorSubstanceDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorSubstanceDefinitionIf 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-5errorSubstanceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceSubstanceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from SubstanceDefinition

Summary

Mandatory: 1 element(9 nested mandatory elements)
Must-Support: 28 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of SubstanceDefinition.name (Closed)

 

Other representations of profile: CSV, Excel, Schematron