Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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: PolymorphicForm - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the pqcmc-polymorphic-form resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. SubstanceDefinition
Definition | The detailed description of a substance, typically at a level beyond what is used for prescribing.
Short | The detailed description of a substance, typically at a level beyond what is used for prescribing
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id 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-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. SubstanceDefinition.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. SubstanceDefinition.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
Short | Contained, inline Resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
6. SubstanceDefinition.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. SubstanceDefinition.identifier
Definition | Identifier by which this substance is known.
Short | optional user designated identifierIdentifier by which this substance is known
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1*
Type | Identifier
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. SubstanceDefinition.structure
Definition | Structural information.
Short | Structural information
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cmc-structure-representation-required: Either a file or string structure representation is required (`representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C45253' | 'C103240') ).exists()`)
12. SubstanceDefinition.structure.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
14. SubstanceDefinition.structure.molecularFormula
Definition | An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] An expression which states the number and type of atoms present in a molecule of a substance.
Short | Molecular FormulaAn expression which states the number and type of atoms present in a molecule of a substance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. SubstanceDefinition.structure.technique
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay. The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.
Short | Substance Characterisation TechniqueThe method used to find the structure e.g. X-ray, NMR
Control | 0..1*
Binding | For example codes, see StructureTechnique http://hl7.org/fhir/ValueSet/substance-structure-technique (example to `http://hl7.org/fhir/ValueSet/substance-structure-technique` ) The method used to elucidate the structure of the drug substance.
Type | CodeableConcept(Text Only Codeable Concept)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. SubstanceDefinition.structure.representation
Definition | A depiction of the structure of the substance.
Short | Impurity Structure Graphic | Impurity Structure Data FileA depiction of the structure of the substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `SubstanceDefinition.structure.representation`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
20. SubstanceDefinition.structure.representation.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. SubstanceDefinition.structure.representation.type
Definition | The kind of structural representation (e.g. full, partial).
Short | The kind of structural representation (e.g. full, partial)
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Representation Types http://hl7.org/fhir/ValueSet/substance-representation-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. SubstanceDefinition.structure.representation:graphic
Slice Name | graphic
Definition | A depiction of the structure of the substance.
Short | A graphical, displayable depiction of the structure (e.g. an SVG, PNG)A depiction of the structure of the substance
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. SubstanceDefinition.structure.representation:graphic.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
28. SubstanceDefinition.structure.representation:graphic.type
Definition | The kind of structural representation (e.g. full, partial).
Short | GraphicThe kind of structural representation (e.g. full, partial)
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Representation Types http://hl7.org/fhir/ValueSet/substance-representation-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C54273" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. SubstanceDefinition.structure.representation:graphic.document
Definition | A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG. An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Short | Impurity Structure GraphicAn attachment with the structural representation e.g. a structure graphic or AnIML file
Control | 10..1
Type | Reference(Literal Reference)(Graphic Reference, DocumentReference)bundled
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. SubstanceDefinition.structure.representation:structureFile
Slice Name | structureFile
Definition | A depiction of the structure of the substance.
Short | machine-readable representation -- attached fileA depiction of the structure of the substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. SubstanceDefinition.structure.representation:structureFile.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
36. SubstanceDefinition.structure.representation:structureFile.type
Definition | The kind of structural representation (e.g. full, partial).
Short | Structure FileThe kind of structural representation (e.g. full, partial)
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Representation Types http://hl7.org/fhir/ValueSet/substance-representation-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C103240" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. SubstanceDefinition.structure.representation:structureFile.document
Definition | An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Short | Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)An attachment with the structural representation e.g. a structure graphic or AnIML file
Control | 10..1
Type | Reference(Literal Reference)(Structure Data Reference, DocumentReference)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. SubstanceDefinition.structure.representation:structureString
Slice Name | structureString
Definition | A depiction of the structure of the substance.
Short | machine-readable representation -- plain textA depiction of the structure of the substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. SubstanceDefinition.structure.representation:structureString.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
44. SubstanceDefinition.structure.representation:structureString.type
Definition | The kind of structural representation (e.g. full, partial).
Short | Structure TextualThe kind of structural representation (e.g. full, partial)
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Representation Types http://hl7.org/fhir/ValueSet/substance-representation-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C45253" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. SubstanceDefinition.structure.representation:structureString.representation
Definition | A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI The structural representation as a text string in a standard format.
Short | Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)The structural representation as a text string in a standard format
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. SubstanceDefinition.structure.representation:structureString.format
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
Short | Drug Substance Impurity Method TypeThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Chemical Structure Data File Type Terminology http://hl7.org/fhir/ValueSet/substance-representation-format (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. SubstanceDefinition.code
Definition | Codes associated with the substance.
Short | Codes associated with the substance
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. SubstanceDefinition.code.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
54. SubstanceDefinition.name
Definition | Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF Names applicable to this substance.
Short | Substance NameNames applicable to this substance
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cmc-name-preferred: Name.preferred: at most one = true (`select(preferred = true).count() < 2`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
56. SubstanceDefinition.name.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
58. SubstanceDefinition.name.name
Definition | The actual name.
Short | The actual name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. SubstanceDefinition.name.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 0..1
Binding | The codes SHALL be taken from For example codes, see Substance Name Type http://hl7.org/fhir/ValueSet/substance-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. SubstanceDefinition.name.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance NameIf this is the preferred name for this substance
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. SubstanceDefinition.name:sub
Slice Name | sub
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. SubstanceDefinition.name:sub.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
68. SubstanceDefinition.name:sub.name
Definition | A non-branded nor registered name that meant for common use. The actual name.
Short | Generic NameThe actual name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. SubstanceDefinition.name:sub.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Substance Name Type http://hl7.org/fhir/ValueSet/substance-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C97054", "display" : "Generic Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. SubstanceDefinition.name:sub.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance NameIf this is the preferred name for this substance
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. SubstanceDefinition.name:gsrs
Slice Name | gsrs
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. SubstanceDefinition.name:gsrs.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
78. SubstanceDefinition.name:gsrs.name
Definition | Default display name identified within FDA Global Substance Registration System (GSRS). The actual name.
Short | GSRS Preferred TermThe actual name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. SubstanceDefinition.name:gsrs.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Substance Name Type http://hl7.org/fhir/ValueSet/substance-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C203355", "display" : "GSRS Preferred Term" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. SubstanceDefinition.name:gsrs.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance NameIf this is the preferred name for this substance
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. SubstanceDefinition.name:isbt
Slice Name | isbt
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. SubstanceDefinition.name:isbt.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
88. SubstanceDefinition.name:isbt.name
Definition | It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/] The actual name.
Short | ISBT-128 DINThe actual name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. SubstanceDefinition.name:isbt.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Substance Name Type http://hl7.org/fhir/ValueSet/substance-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C95517", "display" : "ISBT-128 DIN" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. SubstanceDefinition.name:isbt.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance NameIf this is the preferred name for this substance
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. SubstanceDefinition
2. SubstanceDefinition.identifier
Short | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Must Support | true
4. SubstanceDefinition.structure
Must Support | true
Invariants | cmc-structure-representation-required: Either a file or string structure representation is required (`representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C45253' | 'C103240') ).exists()`)
6. SubstanceDefinition.structure.molecularFormula
Definition | An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]
Short | Molecular Formula
Must Support | true
8. SubstanceDefinition.structure.technique
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.
Short | Substance Characterisation Technique
Control | 0..1
Type | CodeableConcept(Text Only Codeable Concept)
Must Support | true
10. SubstanceDefinition.structure.representation
Short | Impurity Structure Graphic | Impurity Structure Data File
Must Support | true
Slicing | This element introduces a set of slices on `SubstanceDefinition.structure.representation`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
12. SubstanceDefinition.structure.representation.type
Control | 1..?
Binding | The codes SHALL be taken from Representation Types (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Must Support | true
14. SubstanceDefinition.structure.representation:graphic
Slice Name | graphic
Short | A graphical, displayable depiction of the structure (e.g. an SVG, PNG)
Control | 0..1
Must Support | true
16. SubstanceDefinition.structure.representation:graphic.type
Short | Graphic
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C54273" }] }`
18. SubstanceDefinition.structure.representation:graphic.document
Definition | A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.
Short | Impurity Structure Graphic
Control | 1..?
Type | Reference(Literal Reference)(Graphic Reference)bundled
20. SubstanceDefinition.structure.representation:structureFile
Slice Name | structureFile
Short | machine-readable representation -- attached file
Control | 0..*
Must Support | true
22. SubstanceDefinition.structure.representation:structureFile.type
Short | Structure File
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C103240" }] }`
24. SubstanceDefinition.structure.representation:structureFile.document
Short | Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)
Control | 1..?
Type | Reference(Literal Reference)(Structure Data Reference)bundled
Must Support | true
26. SubstanceDefinition.structure.representation:structureString
Slice Name | structureString
Short | machine-readable representation -- plain text
Control | 0..*
Must Support | true
28. SubstanceDefinition.structure.representation:structureString.type
Short | Structure Textual
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C45253" }] }`
30. SubstanceDefinition.structure.representation:structureString.representation
Definition | A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI
Short | Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
Control | 1..?
Must Support | true
32. SubstanceDefinition.structure.representation:structureString.format
Short | Drug Substance Impurity Method Type
Control | 1..?
Binding | The codes SHALL be taken from Chemical Structure Data File Type Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology` )
Must Support | true
34. SubstanceDefinition.code
Control | 0..1
Must Support | true
36. SubstanceDefinition.code.code
38. SubstanceDefinition.code.code.coding
Definition | The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/
Short | UNII
40. SubstanceDefinition.code.code.coding.system
Pattern Value | `http://fdasis.nlm.nih.gov`
42. SubstanceDefinition.name
Definition | Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF
Short | Substance Name
Control | 1..?
Must Support | true
Invariants | cmc-name-preferred: Name.preferred: at most one = true (`select(preferred = true).count() < 2`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
44. SubstanceDefinition.name.type
Binding | The codes SHALL be taken from Substance Name Type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
46. SubstanceDefinition.name.preferred
Short | True when the name type is Substance Name
Must Support | true
48. SubstanceDefinition.name:sub
Slice Name | sub
Control | 0..1
Must Support | true
50. SubstanceDefinition.name:sub.name
Definition | A non-branded nor registered name that meant for common use.
Short | Generic Name
Must Support | true
52. SubstanceDefinition.name:sub.type
Control | 1..?
Must Support | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C97054", "display" : "Generic Name" }] }`
54. SubstanceDefinition.name:sub.preferred
Must Support | true
56. SubstanceDefinition.name:gsrs
Slice Name | gsrs
Control | 0..1
Must Support | true
58. SubstanceDefinition.name:gsrs.name
Definition | Default display name identified within FDA Global Substance Registration System (GSRS).
Short | GSRS Preferred Term
Must Support | true
60. SubstanceDefinition.name:gsrs.type
Control | 1..?
Must Support | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C203355", "display" : "GSRS Preferred Term" }] }`
62. SubstanceDefinition.name:gsrs.preferred
Must Support | true
64. SubstanceDefinition.name:isbt
Slice Name | isbt
Control | 0..1
Must Support | true
66. SubstanceDefinition.name:isbt.name
Definition | It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]
Short | ISBT-128 DIN
Must Support | true
68. SubstanceDefinition.name:isbt.type
Control | 1..?
Must Support | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C95517", "display" : "ISBT-128 DIN" }] }`
70. SubstanceDefinition.name:isbt.preferred
Must Support | true

Guidance on how to interpret the contents of this table can be foundhere

0. SubstanceDefinition
Definition | The detailed description of a substance, typically at a level beyond what is used for prescribing.
Short | The detailed description of a substance, typically at a level beyond what is used for prescribing
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (`contained.where((('#'+id 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-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. SubstanceDefinition.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
Control | 0..1
Type | id
Is Modifier | false
Must Support | false
Summary | true
4. SubstanceDefinition.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. SubstanceDefinition.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. SubstanceDefinition.language
Definition | The base language in which the resource is written.
Short | Language of the resource content
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Control | 0..1
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. SubstanceDefinition.text
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Short | Text summary of the resource, for human interpretation
Comments | Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Control | 0..1 This element is affected by the following invariants: dom-6
Type | Narrative
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. SubstanceDefinition.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
Short | Contained, inline Resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. SubstanceDefinition.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. SubstanceDefinition.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. SubstanceDefinition.identifier
Definition | Identifier by which this substance is known.
Short | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. SubstanceDefinition.version
Definition | A business level version identifier of the substance.
Short | A business level version identifier of the substance
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. SubstanceDefinition.status
Definition | Status of substance within the catalogue e.g. active, retired.
Short | Status of substance within the catalogue e.g. active, retired
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. SubstanceDefinition.classification
Definition | A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).
Short | 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
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. SubstanceDefinition.domain
Definition | If the substance applies to human or veterinary use.
Short | If the substance applies to human or veterinary use
Control | 0..1
Binding | For example codes, see MedicinalProductDomain (example to `http://hl7.org/fhir/ValueSet/medicinal-product-domain` ) Applicable domain for this product (e.g. human, veterinary).
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. SubstanceDefinition.grade
Definition | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).
Short | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Control | 0..*
Binding | For example codes, see SubstanceGrade (example to `http://hl7.org/fhir/ValueSet/substance-grade` ) The quality standard, established benchmark, to which a substance complies
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. SubstanceDefinition.description
Definition | Textual description of the substance.
Short | Textual description of the substance
Control | 0..1
Type | markdown
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. SubstanceDefinition.informationSource
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(Citation)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. SubstanceDefinition.note
Definition | Textual comment about the substance's catalogue or registry record.
Short | Textual comment about the substance's catalogue or registry record
Control | 0..*
Type | Annotation
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. SubstanceDefinition.manufacturer
Definition | The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.
Short | The entity that creates, makes, produces or fabricates the substance
Control | 0..*
Type | Reference(Organization)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. SubstanceDefinition.supplier
Definition | An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.
Short | An entity that is the source for the substance. It may be different from the manufacturer
Control | 0..*
Type | Reference(Organization)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. SubstanceDefinition.moiety
Definition | Moiety, for structural modifications.
Short | Moiety, for structural modifications
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. SubstanceDefinition.moiety.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
44. SubstanceDefinition.moiety.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
46. SubstanceDefinition.moiety.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
48. SubstanceDefinition.moiety.role
Definition | Role that the moiety is playing.
Short | Role that the moiety is playing
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. SubstanceDefinition.moiety.identifier
Definition | Identifier by which this moiety substance is known.
Short | Identifier by which this moiety substance is known
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. SubstanceDefinition.moiety.name
Definition | Textual name for this moiety substance.
Short | Textual name for this moiety substance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. SubstanceDefinition.moiety.stereochemistry
Definition | Stereochemistry type.
Short | Stereochemistry type
Control | 0..1
Binding | For example codes, see Stereochemistry (example to `http://hl7.org/fhir/ValueSet/substance-stereochemistry` ) The optical rotation type of a substance.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. SubstanceDefinition.moiety.opticalActivity
Definition | Optical activity type.
Short | Optical activity type
Control | 0..1
Binding | For example codes, see OpticalActivity (example to `http://hl7.org/fhir/ValueSet/substance-optical-activity` ) The optical rotation type of a substance.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. SubstanceDefinition.moiety.molecularFormula
Definition | Molecular formula for this moiety of this substance, typically using the Hill system.
Short | Molecular formula for this moiety (e.g. with the Hill system)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. SubstanceDefinition.moiety.amount[x]
Definition | Quantitative value for this moiety.
Short | Quantitative value for this moiety
Control | 0..1
Type | Choice of: Quantity, string
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. SubstanceDefinition.moiety.measurementType
Definition | The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.
Short | The measurement type of the quantitative value
Control | 0..1
Binding | For example codes, see SubstanceAmountType (example to `http://hl7.org/fhir/ValueSet/substance-amount-type` ) The relationship between two substance types.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. SubstanceDefinition.characterization
Definition | General specifications for this substance.
Short | General specifications for this substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. SubstanceDefinition.characterization.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
68. SubstanceDefinition.characterization.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
70. SubstanceDefinition.characterization.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
72. SubstanceDefinition.characterization.technique
Definition | The method used to elucidate the characterization of the drug substance. Example: HPLC.
Short | The method used to find the characterization e.g. HPLC
Control | 0..1
Binding | For example codes, see StructureTechnique (example to `http://hl7.org/fhir/ValueSet/substance-structure-technique` ) The method used to elucidate the characterization of the drug substance.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. SubstanceDefinition.characterization.form
Definition | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.
Short | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Control | 0..1
Binding | For example codes, see SubstanceForm (example to `http://hl7.org/fhir/ValueSet/substance-form` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. SubstanceDefinition.characterization.description
Definition | The description or justification in support of the interpretation of the data file.
Short | The description or justification in support of the interpretation of the data file
Control | 0..1
Type | markdown
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. SubstanceDefinition.characterization.file
Definition | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.
Short | 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
Control | 0..*
Type | Attachment
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
80. SubstanceDefinition.property
Definition | General specifications for this substance.
Short | General specifications for this substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
82. SubstanceDefinition.property.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
84. SubstanceDefinition.property.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
86. SubstanceDefinition.property.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
88. SubstanceDefinition.property.type
Definition | A code expressing the type of property.
Short | A code expressing the type of property
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. SubstanceDefinition.property.value[x]
Definition | A value for the property.
Short | A value for the property
Control | 0..1
Type | Choice of: CodeableConcept, Quantity, date, boolean, Attachment
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. SubstanceDefinition.referenceInformation
Definition | General information detailing this substance.
Short | General information detailing this substance
Control | 0..1
Type | Reference(SubstanceReferenceInformation)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. SubstanceDefinition.molecularWeight
Definition | The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.
Short | The average mass of a molecule of a compound
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. SubstanceDefinition.molecularWeight.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
98. SubstanceDefinition.molecularWeight.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
100. SubstanceDefinition.molecularWeight.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
102. SubstanceDefinition.molecularWeight.method
Definition | The method by which the molecular weight was determined.
Short | The method by which the weight was determined
Control | 0..1
Binding | For example codes, see WeightMethod (example to `http://hl7.org/fhir/ValueSet/substance-weight-method` ) The method by which the substance weight was measured.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. SubstanceDefinition.molecularWeight.type
Definition | Type of molecular weight such as exact, average (also known as. number average), weight average.
Short | Type of molecular weight e.g. exact, average, weight average
Control | 0..1
Binding | For example codes, see WeightType (example to `http://hl7.org/fhir/ValueSet/substance-weight-type` ) The type of substance weight measurement.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
106. SubstanceDefinition.molecularWeight.amount
Definition | Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.
Short | Used to capture quantitative values for a variety of elements
Control | 1..1
Type | Quantity
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
108. SubstanceDefinition.structure
Definition | Structural information.
Short | Structural information
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) cmc-structure-representation-required: Either a file or string structure representation is required (`representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C45253' | 'C103240') ).exists()`)
110. SubstanceDefinition.structure.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
112. SubstanceDefinition.structure.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
114. SubstanceDefinition.structure.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
116. SubstanceDefinition.structure.stereochemistry
Definition | Stereochemistry type.
Short | Stereochemistry type
Control | 0..1
Binding | For example codes, see Stereochemistry (example to `http://hl7.org/fhir/ValueSet/substance-stereochemistry` ) The optical rotation type of a substance.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. SubstanceDefinition.structure.opticalActivity
Definition | Optical activity type.
Short | Optical activity type
Control | 0..1
Binding | For example codes, see OpticalActivity (example to `http://hl7.org/fhir/ValueSet/substance-optical-activity` ) The optical rotation type of a substance.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
120. SubstanceDefinition.structure.molecularFormula
Definition | An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]
Short | Molecular Formula
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
122. SubstanceDefinition.structure.molecularFormulaByMoiety
Definition | Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.
Short | Specified per moiety according to the Hill system
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
124. SubstanceDefinition.structure.molecularWeight
Definition | The molecular weight or weight range (for proteins, polymers or nucleic acids).
Short | The molecular weight or weight range
Control | 0..1
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. SubstanceDefinition.structure.technique
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.
Short | Substance Characterisation Technique
Control | 0..1
Binding | For example codes, see StructureTechnique (example to `http://hl7.org/fhir/ValueSet/substance-structure-technique` ) The method used to elucidate the structure of the drug substance.
Type | CodeableConcept(Text Only Codeable Concept)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. SubstanceDefinition.structure.sourceDocument
Definition | The source of information about the structure.
Short | Source of information for the structure
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. SubstanceDefinition.structure.representation
Definition | A depiction of the structure of the substance.
Short | Impurity Structure Graphic | Impurity Structure Data File
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.structure.representation`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
132. SubstanceDefinition.structure.representation.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
134. SubstanceDefinition.structure.representation.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
136. SubstanceDefinition.structure.representation.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
138. SubstanceDefinition.structure.representation.type
Definition | The kind of structural representation (e.g. full, partial).
Short | The kind of structural representation (e.g. full, partial)
Control | 1..1
Binding | The codes SHALL be taken from Representation Types (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
140. SubstanceDefinition.structure.representation.representation
Definition | The structural representation as a text string in a standard format.
Short | The structural representation as a text string in a standard format
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
142. SubstanceDefinition.structure.representation.format
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
Short | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Control | 0..1
Binding | For example codes, see SubstanceRepresentationFormat (example to `http://hl7.org/fhir/ValueSet/substance-representation-format` ) A format of a substance representation.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
144. SubstanceDefinition.structure.representation.document
Definition | An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Short | An attachment with the structural representation e.g. a structure graphic or AnIML file
Control | 0..1
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
146. SubstanceDefinition.structure.representation:graphic
Slice Name | graphic
Definition | A depiction of the structure of the substance.
Short | A graphical, displayable depiction of the structure (e.g. an SVG, PNG)
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
148. SubstanceDefinition.structure.representation:graphic.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
150. SubstanceDefinition.structure.representation:graphic.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
152. SubstanceDefinition.structure.representation:graphic.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
154. SubstanceDefinition.structure.representation:graphic.type
Definition | The kind of structural representation (e.g. full, partial).
Short | Graphic
Control | 1..1
Binding | The codes SHALL be taken from Representation Types (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C54273" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
156. SubstanceDefinition.structure.representation:graphic.representation
Definition | The structural representation as a text string in a standard format.
Short | The structural representation as a text string in a standard format
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
158. SubstanceDefinition.structure.representation:graphic.format
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
Short | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Control | 0..1
Binding | For example codes, see SubstanceRepresentationFormat (example to `http://hl7.org/fhir/ValueSet/substance-representation-format` ) A format of a substance representation.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
160. SubstanceDefinition.structure.representation:graphic.document
Definition | A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.
Short | Impurity Structure Graphic
Control | 1..1
Type | Reference(Literal Reference)(Graphic Reference)bundled
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
162. SubstanceDefinition.structure.representation:structureFile
Slice Name | structureFile
Definition | A depiction of the structure of the substance.
Short | machine-readable representation -- attached file
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
164. SubstanceDefinition.structure.representation:structureFile.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
166. SubstanceDefinition.structure.representation:structureFile.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
168. SubstanceDefinition.structure.representation:structureFile.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
170. SubstanceDefinition.structure.representation:structureFile.type
Definition | The kind of structural representation (e.g. full, partial).
Short | Structure File
Control | 1..1
Binding | The codes SHALL be taken from Representation Types (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C103240" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
172. SubstanceDefinition.structure.representation:structureFile.representation
Definition | The structural representation as a text string in a standard format.
Short | The structural representation as a text string in a standard format
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
174. SubstanceDefinition.structure.representation:structureFile.format
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
Short | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Control | 0..1
Binding | For example codes, see SubstanceRepresentationFormat (example to `http://hl7.org/fhir/ValueSet/substance-representation-format` ) A format of a substance representation.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
176. SubstanceDefinition.structure.representation:structureFile.document
Definition | An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Short | Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)
Control | 1..1
Type | Reference(Literal Reference)(Structure Data Reference)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
178. SubstanceDefinition.structure.representation:structureString
Slice Name | structureString
Definition | A depiction of the structure of the substance.
Short | machine-readable representation -- plain text
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
180. SubstanceDefinition.structure.representation:structureString.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
182. SubstanceDefinition.structure.representation:structureString.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
184. SubstanceDefinition.structure.representation:structureString.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
186. SubstanceDefinition.structure.representation:structureString.type
Definition | The kind of structural representation (e.g. full, partial).
Short | Structure Textual
Control | 1..1
Binding | The codes SHALL be taken from Representation Types (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C45253" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
188. SubstanceDefinition.structure.representation:structureString.representation
Definition | A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI
Short | Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
190. SubstanceDefinition.structure.representation:structureString.format
Definition | The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
Short | Drug Substance Impurity Method Type
Control | 1..1
Binding | The codes SHALL be taken from Chemical Structure Data File Type Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
192. SubstanceDefinition.structure.representation:structureString.document
Definition | An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Short | An attachment with the structural representation e.g. a structure graphic or AnIML file
Control | 0..1
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
194. SubstanceDefinition.code
Definition | Codes associated with the substance.
Short | Codes associated with the substance
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
196. SubstanceDefinition.code.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
198. SubstanceDefinition.code.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
200. SubstanceDefinition.code.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
202. SubstanceDefinition.code.code
Definition | The specific code.
Short | The specific code
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
204. SubstanceDefinition.code.code.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
206. SubstanceDefinition.code.code.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.code.code.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
208. SubstanceDefinition.code.code.coding
Definition | The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/
Short | UNII
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
210. SubstanceDefinition.code.code.coding.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
212. SubstanceDefinition.code.code.coding.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.code.code.coding.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
214. SubstanceDefinition.code.code.coding.system
Definition | The identification of the code system that defines the meaning of the symbol in the code.
Short | Identity of the terminology system
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be unambiguous about the source of the definition of the symbol.
Pattern Value | `http://fdasis.nlm.nih.gov`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
216. SubstanceDefinition.code.code.coding.version
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Short | Version of the system - if relevant
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
218. SubstanceDefinition.code.code.coding.code
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Short | Symbol in syntax defined by the system
Control | 0..1 This element is affected by the following invariants: cod-1
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to refer to a particular code in the system.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
220. SubstanceDefinition.code.code.coding.display
Definition | A representation of the meaning of the code in the system, following the rules of the system.
Short | Representation defined by the system
Control | 0..1 This element is affected by the following invariants: cod-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
222. SubstanceDefinition.code.code.coding.userSelected
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Short | If this coding was chosen directly by the user
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
224. SubstanceDefinition.code.code.text
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
226. SubstanceDefinition.code.status
Definition | Status of the code assignment, for example 'provisional', 'approved'.
Short | Status of the code assignment, for example 'provisional', 'approved'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
228. SubstanceDefinition.code.statusDate
Definition | The date at which the code status was changed as part of the terminology maintenance.
Short | The date at which the code status was changed
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
230. SubstanceDefinition.code.note
Definition | Any comment can be provided in this field, if necessary.
Short | Any comment can be provided in this field
Control | 0..*
Type | Annotation
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
232. SubstanceDefinition.code.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
234. SubstanceDefinition.name
Definition | Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF
Short | Substance Name
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) cmc-name-preferred: Name.preferred: at most one = true (`select(preferred = true).count() < 2`)
Slicing | This element introduces a set of slices on `SubstanceDefinition.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
236. SubstanceDefinition.name.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
238. SubstanceDefinition.name.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
240. SubstanceDefinition.name.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
242. SubstanceDefinition.name.name
Definition | The actual name.
Short | The actual name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
244. SubstanceDefinition.name.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 0..1
Binding | The codes SHALL be taken from Substance Name Type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
246. SubstanceDefinition.name.status
Definition | The status of the name, for example 'current', 'proposed'.
Short | The status of the name e.g. 'current', 'proposed'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
248. SubstanceDefinition.name.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance Name
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
250. SubstanceDefinition.name.language
Definition | Human language that the name is written in.
Short | Human language that the name is written in
Control | 0..*
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
252. SubstanceDefinition.name.domain
Definition | The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.
Short | The use context of this name e.g. as an active ingredient or as a food colour additive
Control | 0..*
Binding | For example codes, see SubstanceNameDomain (example to `http://hl7.org/fhir/ValueSet/substance-name-domain` ) 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.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
254. SubstanceDefinition.name.jurisdiction
Definition | The jurisdiction where this name applies.
Short | The jurisdiction where this name applies
Control | 0..*
Binding | For example codes, see JurisdictionValueSet (example to `http://hl7.org/fhir/ValueSet/jurisdiction` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
256. SubstanceDefinition.name.synonym
Definition | A synonym of this particular name, by which the substance is also known.
Short | A synonym of this particular name, by which the substance is also known
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
258. SubstanceDefinition.name.translation
Definition | A translation for this name into another human language.
Short | A translation for this name into another human language
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
260. SubstanceDefinition.name.official
Definition | Details of the official nature of this name.
Short | Details of the official nature of this name
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
262. SubstanceDefinition.name.official.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
264. SubstanceDefinition.name.official.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
266. SubstanceDefinition.name.official.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
268. SubstanceDefinition.name.official.authority
Definition | Which authority uses this official name.
Short | Which authority uses this official name
Control | 0..1
Binding | The codes SHOULD be taken from SubstanceNameAuthority (preferred to `http://hl7.org/fhir/ValueSet/substance-name-authority` ) An authority that officates substance names.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
270. SubstanceDefinition.name.official.status
Definition | The status of the official name, for example 'draft', 'active', 'retired'.
Short | The status of the official name, for example 'draft', 'active'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
272. SubstanceDefinition.name.official.date
Definition | Date of the official name change.
Short | Date of official name change
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
274. SubstanceDefinition.name.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
276. SubstanceDefinition.name:sub
Slice Name | sub
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
278. SubstanceDefinition.name:sub.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
280. SubstanceDefinition.name:sub.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
282. SubstanceDefinition.name:sub.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
284. SubstanceDefinition.name:sub.name
Definition | A non-branded nor registered name that meant for common use.
Short | Generic Name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
286. SubstanceDefinition.name:sub.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 1..1
Binding | The codes SHALL be taken from Substance Name Type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C97054", "display" : "Generic Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
288. SubstanceDefinition.name:sub.status
Definition | The status of the name, for example 'current', 'proposed'.
Short | The status of the name e.g. 'current', 'proposed'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
290. SubstanceDefinition.name:sub.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance Name
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
292. SubstanceDefinition.name:sub.language
Definition | Human language that the name is written in.
Short | Human language that the name is written in
Control | 0..*
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
294. SubstanceDefinition.name:sub.domain
Definition | The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.
Short | The use context of this name e.g. as an active ingredient or as a food colour additive
Control | 0..*
Binding | For example codes, see SubstanceNameDomain (example to `http://hl7.org/fhir/ValueSet/substance-name-domain` ) 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.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
296. SubstanceDefinition.name:sub.jurisdiction
Definition | The jurisdiction where this name applies.
Short | The jurisdiction where this name applies
Control | 0..*
Binding | For example codes, see JurisdictionValueSet (example to `http://hl7.org/fhir/ValueSet/jurisdiction` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
298. SubstanceDefinition.name:sub.synonym
Definition | A synonym of this particular name, by which the substance is also known.
Short | A synonym of this particular name, by which the substance is also known
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
300. SubstanceDefinition.name:sub.translation
Definition | A translation for this name into another human language.
Short | A translation for this name into another human language
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
302. SubstanceDefinition.name:sub.official
Definition | Details of the official nature of this name.
Short | Details of the official nature of this name
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
304. SubstanceDefinition.name:sub.official.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
306. SubstanceDefinition.name:sub.official.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
308. SubstanceDefinition.name:sub.official.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
310. SubstanceDefinition.name:sub.official.authority
Definition | Which authority uses this official name.
Short | Which authority uses this official name
Control | 0..1
Binding | The codes SHOULD be taken from SubstanceNameAuthority (preferred to `http://hl7.org/fhir/ValueSet/substance-name-authority` ) An authority that officates substance names.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
312. SubstanceDefinition.name:sub.official.status
Definition | The status of the official name, for example 'draft', 'active', 'retired'.
Short | The status of the official name, for example 'draft', 'active'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
314. SubstanceDefinition.name:sub.official.date
Definition | Date of the official name change.
Short | Date of official name change
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
316. SubstanceDefinition.name:sub.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
318. SubstanceDefinition.name:gsrs
Slice Name | gsrs
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
320. SubstanceDefinition.name:gsrs.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
322. SubstanceDefinition.name:gsrs.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
324. SubstanceDefinition.name:gsrs.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
326. SubstanceDefinition.name:gsrs.name
Definition | Default display name identified within FDA Global Substance Registration System (GSRS).
Short | GSRS Preferred Term
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
328. SubstanceDefinition.name:gsrs.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 1..1
Binding | The codes SHALL be taken from Substance Name Type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C203355", "display" : "GSRS Preferred Term" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
330. SubstanceDefinition.name:gsrs.status
Definition | The status of the name, for example 'current', 'proposed'.
Short | The status of the name e.g. 'current', 'proposed'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
332. SubstanceDefinition.name:gsrs.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance Name
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
334. SubstanceDefinition.name:gsrs.language
Definition | Human language that the name is written in.
Short | Human language that the name is written in
Control | 0..*
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
336. SubstanceDefinition.name:gsrs.domain
Definition | The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.
Short | The use context of this name e.g. as an active ingredient or as a food colour additive
Control | 0..*
Binding | For example codes, see SubstanceNameDomain (example to `http://hl7.org/fhir/ValueSet/substance-name-domain` ) 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.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
338. SubstanceDefinition.name:gsrs.jurisdiction
Definition | The jurisdiction where this name applies.
Short | The jurisdiction where this name applies
Control | 0..*
Binding | For example codes, see JurisdictionValueSet (example to `http://hl7.org/fhir/ValueSet/jurisdiction` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
340. SubstanceDefinition.name:gsrs.synonym
Definition | A synonym of this particular name, by which the substance is also known.
Short | A synonym of this particular name, by which the substance is also known
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
342. SubstanceDefinition.name:gsrs.translation
Definition | A translation for this name into another human language.
Short | A translation for this name into another human language
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
344. SubstanceDefinition.name:gsrs.official
Definition | Details of the official nature of this name.
Short | Details of the official nature of this name
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
346. SubstanceDefinition.name:gsrs.official.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
348. SubstanceDefinition.name:gsrs.official.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
350. SubstanceDefinition.name:gsrs.official.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
352. SubstanceDefinition.name:gsrs.official.authority
Definition | Which authority uses this official name.
Short | Which authority uses this official name
Control | 0..1
Binding | The codes SHOULD be taken from SubstanceNameAuthority (preferred to `http://hl7.org/fhir/ValueSet/substance-name-authority` ) An authority that officates substance names.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
354. SubstanceDefinition.name:gsrs.official.status
Definition | The status of the official name, for example 'draft', 'active', 'retired'.
Short | The status of the official name, for example 'draft', 'active'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
356. SubstanceDefinition.name:gsrs.official.date
Definition | Date of the official name change.
Short | Date of official name change
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
358. SubstanceDefinition.name:gsrs.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
360. SubstanceDefinition.name:isbt
Slice Name | isbt
Definition | Names applicable to this substance.
Short | Names applicable to this substance
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
362. SubstanceDefinition.name:isbt.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
364. SubstanceDefinition.name:isbt.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
366. SubstanceDefinition.name:isbt.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
368. SubstanceDefinition.name:isbt.name
Definition | It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]
Short | ISBT-128 DIN
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
370. SubstanceDefinition.name:isbt.type
Definition | Name type, for example 'systematic', 'scientific, 'brand'.
Short | Name type e.g. 'systematic', 'scientific, 'brand'
Control | 1..1
Binding | The codes SHALL be taken from Substance Name Type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C95517", "display" : "ISBT-128 DIN" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
372. SubstanceDefinition.name:isbt.status
Definition | The status of the name, for example 'current', 'proposed'.
Short | The status of the name e.g. 'current', 'proposed'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
374. SubstanceDefinition.name:isbt.preferred
Definition | If this is the preferred name for this substance.
Short | True when the name type is Substance Name
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
376. SubstanceDefinition.name:isbt.language
Definition | Human language that the name is written in.
Short | Human language that the name is written in
Control | 0..*
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
378. SubstanceDefinition.name:isbt.domain
Definition | The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.
Short | The use context of this name e.g. as an active ingredient or as a food colour additive
Control | 0..*
Binding | For example codes, see SubstanceNameDomain (example to `http://hl7.org/fhir/ValueSet/substance-name-domain` ) 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.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
380. SubstanceDefinition.name:isbt.jurisdiction
Definition | The jurisdiction where this name applies.
Short | The jurisdiction where this name applies
Control | 0..*
Binding | For example codes, see JurisdictionValueSet (example to `http://hl7.org/fhir/ValueSet/jurisdiction` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
382. SubstanceDefinition.name:isbt.synonym
Definition | A synonym of this particular name, by which the substance is also known.
Short | A synonym of this particular name, by which the substance is also known
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
384. SubstanceDefinition.name:isbt.translation
Definition | A translation for this name into another human language.
Short | A translation for this name into another human language
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
386. SubstanceDefinition.name:isbt.official
Definition | Details of the official nature of this name.
Short | Details of the official nature of this name
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
388. SubstanceDefinition.name:isbt.official.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
390. SubstanceDefinition.name:isbt.official.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
392. SubstanceDefinition.name:isbt.official.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
394. SubstanceDefinition.name:isbt.official.authority
Definition | Which authority uses this official name.
Short | Which authority uses this official name
Control | 0..1
Binding | The codes SHOULD be taken from SubstanceNameAuthority (preferred to `http://hl7.org/fhir/ValueSet/substance-name-authority` ) An authority that officates substance names.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
396. SubstanceDefinition.name:isbt.official.status
Definition | The status of the official name, for example 'draft', 'active', 'retired'.
Short | The status of the official name, for example 'draft', 'active'
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus (preferred to `http://hl7.org/fhir/ValueSet/publication-status` ) The lifecycle status of an artifact.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
398. SubstanceDefinition.name:isbt.official.date
Definition | Date of the official name change.
Short | Date of official name change
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
400. SubstanceDefinition.name:isbt.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
402. SubstanceDefinition.relationship
Definition | A link between this substance and another, with details of the relationship.
Short | A link between this substance and another
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
404. SubstanceDefinition.relationship.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
406. SubstanceDefinition.relationship.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
408. SubstanceDefinition.relationship.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
410. SubstanceDefinition.relationship.substanceDefinition[x]
Definition | A pointer to another substance, as a resource or just a representational code.
Short | A pointer to another substance, as a resource or a representational code
Control | 0..1
Type | Choice of: Reference(SubstanceDefinition), CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
412. SubstanceDefinition.relationship.type
Definition | For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".
Short | For example "salt to parent", "active moiety"
Control | 1..1
Binding | For example codes, see SubstanceRelationshipType (example to `http://hl7.org/fhir/ValueSet/substance-relationship-type` ) The relationship between two substance types.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
414. SubstanceDefinition.relationship.isDefining
Definition | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.
Short | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
416. SubstanceDefinition.relationship.amount[x]
Definition | A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.
Short | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
Control | 0..1
Type | Choice of: Quantity, Ratio, string
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
418. SubstanceDefinition.relationship.ratioHighLimitAmount
Definition | For use when the numeric has an uncertain range.
Short | For use when the numeric has an uncertain range
Control | 0..1
Type | Ratio
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
420. SubstanceDefinition.relationship.comparator
Definition | An operator for the amount, for example "average", "approximately", "less than".
Short | An operator for the amount, for example "average", "approximately", "less than"
Control | 0..1
Binding | For example codes, see SubstanceAmountType (example to `http://hl7.org/fhir/ValueSet/substance-amount-type` ) The relationship between two substance types.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
422. SubstanceDefinition.relationship.source
Definition | Supporting literature.
Short | Supporting literature
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
424. SubstanceDefinition.nucleicAcid
Definition | Data items specific to nucleic acids.
Short | Data items specific to nucleic acids
Control | 0..1
Type | Reference(SubstanceNucleicAcid)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
426. SubstanceDefinition.polymer
Definition | Data items specific to polymers.
Short | Data items specific to polymers
Control | 0..1
Type | Reference(SubstancePolymer)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
428. SubstanceDefinition.protein
Definition | Data items specific to proteins.
Short | Data items specific to proteins
Control | 0..1
Type | Reference(SubstanceProtein)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
430. SubstanceDefinition.sourceMaterial
Definition | Material or taxonomic/anatomical source for the substance.
Short | Material or taxonomic/anatomical source
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
432. SubstanceDefinition.sourceMaterial.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
434. SubstanceDefinition.sourceMaterial.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
436. SubstanceDefinition.sourceMaterial.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
438. SubstanceDefinition.sourceMaterial.type
Definition | A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.
Short | Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Control | 0..1
Binding | For example codes, see SourceMaterialType (example to `http://hl7.org/fhir/ValueSet/substance-source-material-type` ) A classification that provides the origin of the substance raw material.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
440. SubstanceDefinition.sourceMaterial.genus
Definition | The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
Short | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Control | 0..1
Binding | For example codes, see SourceMaterialGenus (example to `http://hl7.org/fhir/ValueSet/substance-source-material-genus` ) The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
442. SubstanceDefinition.sourceMaterial.species
Definition | The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.
Short | The species of an organism e.g. the Latin epithet of the species of the plant/animal
Control | 0..1
Binding | For example codes, see SourceMaterialSpecies (example to `http://hl7.org/fhir/ValueSet/substance-source-material-species` ) A species of origin a substance raw material.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
444. SubstanceDefinition.sourceMaterial.part
Definition | An anatomical origin of the source material within an organism.
Short | An anatomical origin of the source material within an organism
Control | 0..1
Binding | For example codes, see SourceMaterialPart (example to `http://hl7.org/fhir/ValueSet/substance-source-material-part` ) An anatomical origin of the source material within an organism.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
446. SubstanceDefinition.sourceMaterial.countryOfOrigin
Definition | The country or countries where the material is harvested.
Short | The country or countries where the material is harvested
Control | 0..*
Binding | The codes SHALL be taken from CountryValueSet (required to `http://hl7.org/fhir/ValueSet/country|5.0.0` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)