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-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Active as of 2024-12-04 |
Definitions for the pqcmc-drug-product-substance-impurity resource profile.
Guidance on how to interpret the contents of this table can be found here
0. SubstanceDefinition | |
Invariants | cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required (structure.representation.type.coding.where(
system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and
code = 'C103240'
).exists().not() implies (
code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).exists()
) ) |
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.classification | |
Definition | A categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables. |
Short | Impurity Classification |
Control | 1..? |
Binding | The codes SHALL be taken from Impurity Classification Terminology (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology ) |
Must Support | true |
6. SubstanceDefinition.characterization | |
Must Support | true |
8. SubstanceDefinition.characterization.technique | |
Definition | The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc. |
Short | Substance Characterisation Technique |
Type | CodeableConcept(Text Only Codeable Concept) |
Must Support | true |
10. SubstanceDefinition.characterization.description | |
Short | Analysis Narrative Text and Table |
Must Support | true |
12. SubstanceDefinition.characterization.file | |
Short | Impurity Analysis Graphic | Impurity Analytical Instrument Data File |
Must Support | true |
Slicing | This element introduces a set of slices on SubstanceDefinition.characterization.file . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
14. SubstanceDefinition.characterization.file:AnalysisGraphic | |
Slice Name | AnalysisGraphic |
Definition | Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined] |
Short | Analysis Graphic |
Control | 0..* |
Type | Attachment(Analysis Graphic) |
16. SubstanceDefinition.characterization.file:AnalyticalInstrumentData | |
Slice Name | AnalyticalInstrumentData |
Definition | Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF. |
Short | Analytical Instrument Data File |
Control | 0..* |
Type | Attachment(Analytical Instrument Data) |
18. SubstanceDefinition.structure | |
Must Support | true |
20. 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 | Impurity Substance Characterisation Technique |
Type | CodeableConcept(Text Only Codeable Concept) |
Must Support | true |
22. 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: |
24. 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 |
26. SubstanceDefinition.structure.representation:graphic | |
Slice Name | graphic |
Short | A graphical, displayable depiction of the structure (e.g. an SVG, PNG) |
Control | 0..1 |
28. SubstanceDefinition.structure.representation:graphic.type | |
Short | Graphic |
Pattern Value | { |
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. |
Short | Impurity Structure Graphic |
Control | 1..? |
Type | Reference(Literal Reference)(Graphic Reference)bundled |
32. SubstanceDefinition.structure.representation:structureFile | |
Slice Name | structureFile |
Short | machine-readable representation -- attached file |
Control | 0..* |
34. SubstanceDefinition.structure.representation:structureFile.type | |
Short | Structure File |
Pattern Value | { |
36. 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 |
38. SubstanceDefinition.structure.representation:structureString | |
Slice Name | structureString |
Short | machine-readable representation -- plain text |
Control | 0..* |
40. SubstanceDefinition.structure.representation:structureString.type | |
Short | Structure Textual |
Pattern Value | { |
42. 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 |
44. 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 |
46. SubstanceDefinition.code | |
Must Support | true |
Slicing | This element introduces a set of slices on SubstanceDefinition.code . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
48. SubstanceDefinition.code:unii | |
Slice Name | unii |
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 |
Control | 0..1 |
50. SubstanceDefinition.code:unii.code | |
Control | 1..? |
Must Support | true |
52. SubstanceDefinition.code:unii.code.coding | |
Control | 1..1 |
Must Support | true |
54. SubstanceDefinition.code:unii.code.coding.system | |
Control | 1..? |
Must Support | true |
Pattern Value | http://fdasis.nlm.nih.gov |
56. SubstanceDefinition.code:uniProt | |
Slice Name | uniProt |
Definition | The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/ |
Short | UniProt ID |
Control | 0..1 |
58. SubstanceDefinition.code:uniProt.code | |
Control | 1..? |
Must Support | true |
60. SubstanceDefinition.code:uniProt.code.coding | |
Control | 1..1 |
Must Support | true |
62. SubstanceDefinition.code:uniProt.code.coding.system | |
Control | 1..? |
Must Support | true |
Pattern Value | https://www.uniprot.org |
64. 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: |
66. 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 ) |
68. SubstanceDefinition.name.preferred | |
Short | True when the name type is Substance Name |
Must Support | true |
70. SubstanceDefinition.name:sub | |
Slice Name | sub |
Control | 0..1 |
Must Support | true |
72. SubstanceDefinition.name:sub.name | |
Definition | A non-branded nor registered name that meant for common use. |
Short | Generic Name |
Must Support | true |
74. SubstanceDefinition.name:sub.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
76. SubstanceDefinition.name:sub.preferred | |
Must Support | true |
78. SubstanceDefinition.name:gsrs | |
Slice Name | gsrs |
Control | 0..1 |
Must Support | true |
80. SubstanceDefinition.name:gsrs.name | |
Definition | Default display name identified within FDA Global Substance Registration System (GSRS). |
Short | GSRS Preferred Term |
Must Support | true |
82. SubstanceDefinition.name:gsrs.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
84. SubstanceDefinition.name:gsrs.preferred | |
Must Support | true |
86. SubstanceDefinition.name:isbt | |
Slice Name | isbt |
Control | 0..1 |
Must Support | true |
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/] |
Short | ISBT-128 DIN |
Must Support | true |
90. SubstanceDefinition.name:isbt.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
92. SubstanceDefinition.name:isbt.preferred | |
Must Support | true |
94. SubstanceDefinition.name:comp | |
Slice Name | comp |
Control | 0..1 |
Must Support | true |
96. SubstanceDefinition.name:comp.name | |
Definition | An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined] |
Short | Company ID/Code |
Must Support | true |
98. SubstanceDefinition.name:comp.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
Guidance on how to interpret the contents of this table can be found here
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()) cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required ( structure.representation.type.coding.where(
system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and
code = 'C103240'
).exists().not() implies (
code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).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.classification | |
Definition | A categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables. 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 | Impurity ClassificationA 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 | 10..* |
Binding | The codes SHALL be taken from For codes, see Impurity Classification Terminology (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-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())) |
12. SubstanceDefinition.characterization | |
Definition | General specifications for this substance. |
Short | General specifications for this 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())) |
14. 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()) |
16. SubstanceDefinition.characterization.technique | |
Definition | The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc. The method used to elucidate the characterization of the drug substance. Example: HPLC. |
Short | Substance Characterisation TechniqueThe method used to find the characterization e.g. HPLC |
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. |
Control | 0..1 |
Binding | For example codes, see StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique (example to http://hl7.org/fhir/ValueSet/substance-structure-technique )The method used to elucidate the characterization of the drug substance. |
Type | CodeableConcept(Text Only Codeable Concept) |
Is Modifier | false |
Must Support | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
18. SubstanceDefinition.characterization.description | |
Definition | The description or justification in support of the interpretation of the data file. |
Short | Analysis Narrative Text and TableThe 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 | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. 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 | Impurity Analysis Graphic | Impurity Analytical Instrument Data FileThe 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 | 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.characterization.file . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
22. SubstanceDefinition.characterization.file:AnalysisGraphic | |
Slice Name | AnalysisGraphic |
Definition | Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined] 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 | Analysis GraphicThe 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 |
Comments | When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent". |
Control | 0..* |
Type | Attachment(Analysis Graphic) |
Is Modifier | false |
Must Support | false |
Invariants | att-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists() )ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. SubstanceDefinition.characterization.file:AnalyticalInstrumentData | |
Slice Name | AnalyticalInstrumentData |
Definition | Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF. 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 | Analytical Instrument Data FileThe 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 |
Comments | When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent". |
Control | 0..* |
Type | Attachment(Analytical Instrument Data) |
Is Modifier | false |
Must Support | false |
Invariants | att-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists() )ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
26. 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())) |
28. 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()) |
30. 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 | Impurity Substance Characterisation TechniqueThe method used to find the structure e.g. X-ray, NMR |
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. |
Control | 0..* |
Binding | For example codes, see StructureTechniquehttp://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 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
32. 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: |
34. 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()) |
36. 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 Typeshttp://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())) |
38. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. 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()) |
42. 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 | 0..1 |
Binding | For example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
44. 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())) |
46. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
48. 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()) |
50. 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 | 0..1 |
Binding | For example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
52. 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())) |
54. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
56. 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()) |
58. 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 | 0..1 |
Binding | For example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
60. 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())) |
62. 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 Terminologyhttp://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())) |
64. SubstanceDefinition.code | |
Definition | Codes associated with the substance. |
Short | Codes associated with 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.code . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
66. 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()) |
68. SubstanceDefinition.code:unii | |
Slice Name | unii |
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/ Codes associated with the substance. |
Short | UNIICodes associated with the substance |
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())) |
70. SubstanceDefinition.code:unii.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.code:unii.code | |
Definition | The specific code. |
Short | The specific code |
Control | 10..1 |
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())) |
74. SubstanceDefinition.code:unii.code.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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 | 10..1* |
Type | Coding |
Is Modifier | false |
Must Support | true |
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())) |
76. SubstanceDefinition.code:unii.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 | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
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())) |
78. SubstanceDefinition.code:uniProt | |
Slice Name | uniProt |
Definition | The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/ Codes associated with the substance. |
Short | UniProt IDCodes associated with the substance |
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())) |
80. SubstanceDefinition.code:uniProt.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()) |
82. SubstanceDefinition.code:uniProt.code | |
Definition | The specific code. |
Short | The specific code |
Control | 10..1 |
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())) |
84. SubstanceDefinition.code:uniProt.code.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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 | 10..1* |
Type | Coding |
Is Modifier | false |
Must Support | true |
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())) |
86. SubstanceDefinition.code:uniProt.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 | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://www.uniprot.org |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
88. 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: |
90. 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()) |
92. 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())) |
94. 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 Typehttp://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())) |
96. 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())) |
98. 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())) |
100. 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()) |
102. 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())) |
104. SubstanceDefinition.name:sub.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 10..1 |
Binding | For example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
106. SubstanceDefinition.name:sub.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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())) |
108. 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())) |
110. 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()) |
112. 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())) |
114. SubstanceDefinition.name:gsrs.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 10..1 |
Binding | For example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
116. SubstanceDefinition.name:gsrs.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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())) |
118. 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())) |
120. 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()) |
122. 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())) |
124. SubstanceDefinition.name:isbt.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 10..1 |
Binding | For example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
126. SubstanceDefinition.name:isbt.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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())) |
128. SubstanceDefinition.name:comp | |
Slice Name | comp |
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())) |
130. SubstanceDefinition.name:comp.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()) |
132. SubstanceDefinition.name:comp.name | |
Definition | An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined] The actual name. |
Short | Company ID/CodeThe 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())) |
134. SubstanceDefinition.name:comp.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 10..1 |
Binding | For example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
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 found here
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() )cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required ( structure.representation.type.coding.where(
system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and
code = 'C103240'
).exists().not() implies (
code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).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 categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables. |
Short | Impurity Classification |
Control | 1..* |
Binding | The codes SHALL be taken from Impurity Classification Terminology (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-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()) ) |
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 | true |
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 technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc. |
Short | Substance Characterisation Technique |
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. |
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(Text Only Codeable Concept) |
Is Modifier | false |
Must Support | 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 | Analysis Narrative Text and Table |
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 | true |
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 | Impurity Analysis Graphic | Impurity Analytical Instrument Data File |
Control | 0..* |
Type | Attachment |
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.characterization.file . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
80. SubstanceDefinition.characterization.file:AnalysisGraphic | |
Slice Name | AnalysisGraphic |
Definition | Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined] |
Short | Analysis Graphic |
Comments | When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent". |
Control | 0..* |
Type | Attachment(Analysis Graphic) |
Is Modifier | false |
Must Support | false |
Invariants | att-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists() )ele-1: All FHIR elements must have a @value or children ( hasValue() or (children().count() > id.count()) ) |
82. SubstanceDefinition.characterization.file:AnalyticalInstrumentData | |
Slice Name | AnalyticalInstrumentData |
Definition | Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF. |
Short | Analytical Instrument Data File |
Comments | When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent". |
Control | 0..* |
Type | Attachment(Analytical Instrument Data) |
Is Modifier | false |
Must Support | false |
Invariants | att-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists() )ele-1: All FHIR elements must have a @value or children ( hasValue() or (children().count() > id.count()) ) |
84. 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()) ) |
86. 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 |
88. 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() ) |
90. 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() ) |
92. 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()) ) |
94. 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()) ) |
96. 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()) ) |
98. 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()) ) |
100. 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 |
102. 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() ) |
104. 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() ) |
106. 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()) ) |
108. 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()) ) |
110. 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()) ) |
112. 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()) ) |
114. 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 |
116. 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() ) |
118. 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() ) |
120. 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()) ) |
122. 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()) ) |
124. SubstanceDefinition.structure.molecularFormula | |
Definition | An expression which states the number and type of atoms present in a molecule of a substance. |
Short | An 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
126. 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()) ) |
128. 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()) ) |
130. 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 | Impurity Substance Characterisation Technique |
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. |
Control | 0..* |
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 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
132. 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()) ) |
134. 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: |
136. 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 |
138. 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() ) |
140. 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() ) |
142. 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()) ) |
144. 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()) ) |
146. 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()) ) |
148. 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()) ) |
150. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
152. 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 |
154. 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() ) |
156. 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() ) |
158. SubstanceDefinition.structure.representation:graphic.type | |
Definition | The kind of structural representation (e.g. full, partial). |
Short | Graphic |
Control | 0..1 |
Binding | For example codes, see SubstanceRepresentationType (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
160. 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()) ) |
162. 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()) ) |
164. 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()) ) |
166. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
168. 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 |
170. 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() ) |
172. 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() ) |
174. SubstanceDefinition.structure.representation:structureFile.type | |
Definition | The kind of structural representation (e.g. full, partial). |
Short | Structure File |
Control | 0..1 |
Binding | For example codes, see SubstanceRepresentationType (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
176. 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()) ) |
178. 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()) ) |
180. 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()) ) |
182. 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 | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
184. 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 |
186. 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() ) |
188. 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() ) |
190. SubstanceDefinition.structure.representation:structureString.type | |
Definition | The kind of structural representation (e.g. full, partial). |
Short | Structure Textual |
Control | 0..1 |
Binding | For example codes, see SubstanceRepresentationType (example to http://hl7.org/fhir/ValueSet/substance-representation-type )A format of a substance representation. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
192. 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()) ) |
194. 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()) ) |
196. 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()) ) |
198. SubstanceDefinition.code | |
Definition | Codes associated with the substance. |
Short | Codes associated with 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.code . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
200. 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 |
202. 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() ) |
204. 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() ) |
206. 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()) ) |
208. 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()) ) |
210. 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()) ) |
212. 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()) ) |
214. 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()) ) |
216. SubstanceDefinition.code:unii | |
Slice Name | unii |
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 |
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()) ) |
218. SubstanceDefinition.code:unii.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 |
220. SubstanceDefinition.code:unii.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() ) |
222. SubstanceDefinition.code:unii.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() ) |
224. SubstanceDefinition.code:unii.code | |
Definition | The specific code. |
Short | The specific code |
Control | 1..1 |
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()) ) |
226. SubstanceDefinition.code:unii.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 |
228. SubstanceDefinition.code:unii.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: |
230. SubstanceDefinition.code:unii.code.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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 | 1..1 |
Type | Coding |
Is Modifier | false |
Must Support | true |
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()) ) |
232. SubstanceDefinition.code:unii.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 |
234. SubstanceDefinition.code:unii.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: |
236. SubstanceDefinition.code:unii.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 | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
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()) ) |
238. SubstanceDefinition.code:unii.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()) ) |
240. SubstanceDefinition.code:unii.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()) ) |
242. SubstanceDefinition.code:unii.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()) ) |
244. SubstanceDefinition.code:unii.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()) ) |
246. SubstanceDefinition.code:unii.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()) ) |
248. SubstanceDefinition.code:unii.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()) ) |
250. SubstanceDefinition.code:unii.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()) ) |
252. SubstanceDefinition.code:unii.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()) ) |
254. SubstanceDefinition.code:unii.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()) ) |
256. SubstanceDefinition.code:uniProt | |
Slice Name | uniProt |
Definition | The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/ |
Short | UniProt ID |
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()) ) |
258. SubstanceDefinition.code:uniProt.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 |
260. SubstanceDefinition.code:uniProt.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() ) |
262. SubstanceDefinition.code:uniProt.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() ) |
264. SubstanceDefinition.code:uniProt.code | |
Definition | The specific code. |
Short | The specific code |
Control | 1..1 |
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()) ) |
266. SubstanceDefinition.code:uniProt.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 |
268. SubstanceDefinition.code:uniProt.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: |
270. SubstanceDefinition.code:uniProt.code.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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 | 1..1 |
Type | Coding |
Is Modifier | false |
Must Support | true |
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()) ) |
272. SubstanceDefinition.code:uniProt.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 |
274. SubstanceDefinition.code:uniProt.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: |
276. SubstanceDefinition.code:uniProt.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 | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://www.uniprot.org |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
278. SubstanceDefinition.code:uniProt.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()) ) |
280. SubstanceDefinition.code:uniProt.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()) ) |
282. SubstanceDefinition.code:uniProt.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()) ) |
284. SubstanceDefinition.code:uniProt.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()) ) |
286. SubstanceDefinition.code:uniProt.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()) ) |
288. SubstanceDefinition.code:uniProt.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()) ) |
290. SubstanceDefinition.code:uniProt.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()) ) |
292. SubstanceDefinition.code:uniProt.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()) ) |
294. SubstanceDefinition.code:uniProt.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()) ) |
296. 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: |
298. 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 |
300. 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() ) |
302. 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() ) |
304. 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()) ) |
306. 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()) ) |
308. 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()) ) |
310. 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()) ) |
312. 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()) ) |
314. 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()) ) |
316. 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()) ) |
318. 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()) ) |
320. 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()) ) |
322. 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()) ) |
324. 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 |
326. 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() ) |
328. 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() ) |
330. 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()) ) |
332. 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()) ) |
334. 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()) ) |
336. 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()) ) |
338. 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()) ) |
340. 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 |
342. 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() ) |
344. 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() ) |
346. 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()) ) |
348. SubstanceDefinition.name:sub.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 1..1 |
Binding | For example codes, see SubstanceNameType (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
350. 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()) ) |
352. SubstanceDefinition.name:sub.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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()) ) |
354. 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()) ) |
356. 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()) ) |
358. 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()) ) |
360. 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()) ) |
362. 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()) ) |
364. 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()) ) |
366. 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 |
368. 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() ) |
370. 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() ) |
372. 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()) ) |
374. 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()) ) |
376. 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()) ) |
378. 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()) ) |
380. 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()) ) |
382. 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 |
384. 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() ) |
386. 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() ) |
388. 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()) ) |
390. SubstanceDefinition.name:gsrs.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 1..1 |
Binding | For example codes, see SubstanceNameType (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
392. 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()) ) |
394. SubstanceDefinition.name:gsrs.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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()) ) |
396. 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()) ) |
398. 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()) ) |
400. 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()) ) |
402. 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()) ) |
404. 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()) ) |
406. 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()) ) |
408. 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 |
410. 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() ) |
412. 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() ) |
414. 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()) ) |
416. 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()) ) |
418. 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()) ) |
420. 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()) ) |
422. 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()) ) |
424. 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 |
426. 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() ) |
428. 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() ) |
430. 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()) ) |
432. SubstanceDefinition.name:isbt.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 1..1 |
Binding | For example codes, see SubstanceNameType (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
434. 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()) ) |
436. SubstanceDefinition.name:isbt.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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()) ) |
438. 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()) ) |
440. 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()) ) |
442. 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()) ) |
444. 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()) ) |
446. 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()) ) |
448. 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()) ) |
450. 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 |
452. 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() ) |
454. 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() ) |
456. 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()) ) |
458. 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()) ) |
460. 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()) ) |
462. 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()) ) |
464. SubstanceDefinition.name:comp | |
Slice Name | comp |
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()) ) |
466. SubstanceDefinition.name:comp.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 |
468. SubstanceDefinition.name:comp.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() ) |
470. SubstanceDefinition.name:comp.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() ) |
472. SubstanceDefinition.name:comp.name | |
Definition | An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined] |
Short | Company ID/Code |
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()) ) |
474. SubstanceDefinition.name:comp.type | |
Definition | Name type, for example 'systematic', 'scientific, 'brand'. |
Short | Name type e.g. 'systematic', 'scientific, 'brand' |
Control | 1..1 |
Binding | For example codes, see SubstanceNameType (example to http://hl7.org/fhir/ValueSet/substance-name-type )The type of a name given to a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Pattern Value | { |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
476. SubstanceDefinition.name:comp.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()) ) |
478. SubstanceDefinition.name:comp.preferred | |
Definition | If this is the preferred name for this substance. |
Short | If 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 | false |
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()) ) |
480. SubstanceDefinition.name:comp.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()) ) |
482. SubstanceDefinition.name:comp.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()) ) |
484. SubstanceDefinition.name:comp.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()) ) |
486. SubstanceDefinition.name:comp.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()) ) |
488. SubstanceDefinition.name:comp.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()) ) |
490. SubstanceDefinition.name:comp.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()) ) |
492. SubstanceDefinition.name:comp.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 |
494. SubstanceDefinition.name:comp.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() ) |
496. SubstanceDefinition.name:comp.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() ) |
498. SubstanceDefinition.name:comp.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()) ) |
500. SubstanceDefinition.name:comp.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()) ) |
502. SubstanceDefinition.name:comp.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()) ) |
504. SubstanceDefinition.name:comp.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()) ) |
506. 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()) ) |
508. 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 |
510. 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() ) |
512. 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() ) |
514. 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()) ) |
516. 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()) ) |
518. 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()) ) |
520. 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()) ) |
522. 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()) ) |
524. 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()) ) |
526. 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()) ) |
528. 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()) ) |
530. 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()) ) |
532. 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()) ) |
534. 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()) ) |
536. 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 |
538. 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() ) |
540. 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() ) |
542. 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()) ) |
544. 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()) ) |
546. 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()) ) |
548. 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()) ) |
550. 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()) ) |