Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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 2024-10-30 |
Definitions for the pqcmc-drug-substance-nomenclature-structure resource profile.
Guidance on how to interpret the contents of this table can be found here
0. SubstanceDefinition | |
Invariants | cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
implies code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).exists())
and (classification.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and
code = 'C17021'
).exists() implies code.where(
code.coding.exists(system = 'https://www.uniprot.org')
).exists()) )cmc-name-isbt: Name.type ISBT 128 required for blood products. ( classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy') )cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. ( classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists() )cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ( (classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7] |
Short | Substance Type |
Control | 1..1 |
Binding | The codes SHALL be taken from Substance Classification (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification ) |
Must Support | true |
6. SubstanceDefinition.manufacturer | |
Control | 1..1 |
Type | Reference(Literal Reference)(Basic Organization)bundled |
Must Support | true |
8. SubstanceDefinition.supplier | |
Control | 0..1 |
Type | Reference(Literal Reference)(Basic Organization)bundled |
Must Support | true |
10. 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. [Source: Merriam Webster] |
Short | Molecular Weight |
Control | 0..1 |
Must Support | true |
12. SubstanceDefinition.molecularWeight.amount | |
Binding | Unless not suitable, these codes SHALL be taken from Units Of Measure (extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure ) |
Must Support | true |
14. SubstanceDefinition.molecularWeight.amount.unit | |
Definition | The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055] |
Short | Molecular Weight UOM |
16. SubstanceDefinition.molecularWeight.amount.code | |
Control | 1..? |
Must Support | true |
18. SubstanceDefinition.structure | |
Control | 1..? |
Must Support | true |
Invariants | cmc-structure-representation-required: Either a file or string structure representation is required (representation.type.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'
and (code in ('C45253' | 'C103240'))
).exists() ) |
20. SubstanceDefinition.structure.molecularFormula | |
Definition | Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD |
Short | Molecular Formula | Biopolymer Sequence |
Must Support | true |
22. SubstanceDefinition.structure.technique | |
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay. |
Short | Substance Characterisation Technique |
Control | 1..1 |
Type | CodeableConcept(Text Only Codeable Concept) |
Must Support | true |
24. SubstanceDefinition.structure.representation | |
Short | Impurity Structure Graphic | Impurity Structure Data File |
Control | 1..? |
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: |
26. 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 |
28. SubstanceDefinition.structure.representation:graphic | |
Slice Name | graphic |
Short | A graphical, displayable depiction of the structure (e.g. an SVG, PNG) |
Control | 0..1 |
30. SubstanceDefinition.structure.representation:graphic.type | |
Short | Graphic |
Pattern Value | { |
32. 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 |
34. SubstanceDefinition.structure.representation:structureFile | |
Slice Name | structureFile |
Short | machine-readable representation -- attached file |
Control | 0..* |
36. SubstanceDefinition.structure.representation:structureFile.type | |
Short | Structure File |
Pattern Value | { |
38. 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 |
40. SubstanceDefinition.structure.representation:structureString | |
Slice Name | structureString |
Short | machine-readable representation -- plain text |
Control | 0..* |
42. SubstanceDefinition.structure.representation:structureString.type | |
Short | Structure Textual |
Pattern Value | { |
44. 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 |
46. 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 |
48. SubstanceDefinition.code | |
Control | 1..? |
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: |
50. 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 |
52. SubstanceDefinition.code:unii.code | |
Control | 1..? |
Must Support | true |
54. SubstanceDefinition.code:unii.code.coding | |
Control | 1..1 |
Must Support | true |
56. SubstanceDefinition.code:unii.code.coding.system | |
Control | 1..? |
Must Support | true |
Pattern Value | http://fdasis.nlm.nih.gov |
58. 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 |
60. SubstanceDefinition.code:uniProt.code | |
Control | 1..? |
Must Support | true |
62. SubstanceDefinition.code:uniProt.code.coding | |
Control | 1..1 |
Must Support | true |
64. SubstanceDefinition.code:uniProt.code.coding.system | |
Control | 1..? |
Must Support | true |
Pattern Value | https://www.uniprot.org |
66. SubstanceDefinition.name | |
Definition | Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF |
Short | Subtance 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: |
68. 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 ) |
70. SubstanceDefinition.name.preferred | |
Short | True when the name type is Substance Name |
Must Support | true |
72. SubstanceDefinition.name:sys | |
Slice Name | sys |
Control | 0..1 |
Must Support | true |
74. SubstanceDefinition.name:sys.name | |
Definition | A name derived directly from the chemical structure. [Source: SME Defined] |
Short | Systematic |
Must Support | true |
76. SubstanceDefinition.name:sys.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
78. SubstanceDefinition.name:sys.preferred | |
Must Support | true |
80. SubstanceDefinition.name:sub | |
Slice Name | sub |
Control | 0..1 |
Must Support | true |
82. SubstanceDefinition.name:sub.name | |
Definition | A non-branded nor registered name that meant for common use. |
Short | Generic |
Must Support | true |
84. SubstanceDefinition.name:sub.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
86. SubstanceDefinition.name:sub.preferred | |
Must Support | true |
88. SubstanceDefinition.name:brand | |
Slice Name | brand |
Control | 0..1 |
Must Support | true |
90. SubstanceDefinition.name:brand.name | |
Definition | The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies. |
Short | Brand |
Must Support | true |
92. SubstanceDefinition.name:brand.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
94. SubstanceDefinition.name:brand.preferred | |
Must Support | true |
96. SubstanceDefinition.name:gsrs | |
Slice Name | gsrs |
Control | 0..1 |
Must Support | true |
98. SubstanceDefinition.name:gsrs.name | |
Definition | Default display name identified within FDA Global Substance Registration System (GSRS). |
Short | GSRS Preferred Term |
Must Support | true |
100. SubstanceDefinition.name:gsrs.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
102. SubstanceDefinition.name:gsrs.preferred | |
Must Support | true |
104. SubstanceDefinition.name:usp | |
Slice Name | usp |
Control | 0..1 |
Must Support | true |
106. SubstanceDefinition.name:usp.name | |
Definition | A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined] |
Short | USP-NF Established Name |
Must Support | true |
108. SubstanceDefinition.name:usp.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
110. SubstanceDefinition.name:usp.preferred | |
Must Support | true |
112. SubstanceDefinition.name:cas | |
Slice Name | cas |
Control | 0..1 |
Must Support | true |
114. SubstanceDefinition.name:cas.name | |
Definition | Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2] |
Short | CAS Number |
Must Support | true |
116. SubstanceDefinition.name:cas.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
118. SubstanceDefinition.name:cas.preferred | |
Must Support | true |
120. SubstanceDefinition.name:inn | |
Slice Name | inn |
Control | 0..1 |
Must Support | true |
122. SubstanceDefinition.name:inn.name | |
Definition | International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol |
Short | INN |
Must Support | true |
124. SubstanceDefinition.name:inn.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
126. SubstanceDefinition.name:inn.preferred | |
Must Support | true |
128. SubstanceDefinition.name:usan | |
Slice Name | usan |
Control | 0..1 |
Must Support | true |
130. SubstanceDefinition.name:usan.name | |
Definition | A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen |
Short | USAN |
Must Support | true |
132. SubstanceDefinition.name:usan.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
134. SubstanceDefinition.name:usan.preferred | |
Must Support | true |
136. SubstanceDefinition.name:iupac | |
Slice Name | iupac |
Control | 0..1 |
Must Support | true |
138. SubstanceDefinition.name:iupac.name | |
Definition | A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide |
Short | IUPAC Name |
Must Support | true |
140. SubstanceDefinition.name:iupac.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
142. SubstanceDefinition.name:iupac.preferred | |
Must Support | true |
144. SubstanceDefinition.name:isbt | |
Slice Name | isbt |
Control | 0..1 |
Must Support | true |
146. 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 |
148. SubstanceDefinition.name:isbt.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
150. SubstanceDefinition.name:isbt.preferred | |
Must Support | true |
152. SubstanceDefinition.name:comp | |
Slice Name | comp |
Control | 0..1 |
Must Support | true |
154. 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 |
156. SubstanceDefinition.name:comp.type | |
Control | 1..? |
Must Support | true |
Pattern Value | { |
158. SubstanceDefinition.name:comp.preferred | |
Must Support | true |
160. SubstanceDefinition.relationship | |
Must Support | true |
162. SubstanceDefinition.relationship.substanceDefinition[x] | |
Short | The substance definition of a polyphorm of the Drug Substance |
Type | Reference(Literal Reference)(Polymorphic Form)bundled, CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
164. SubstanceDefinition.relationship.type | |
Short | Polymorph |
Type | CodeableConcept(Text Only Codeable Concept) |
166. SubstanceDefinition.relationship.type.text | |
Pattern Value | Polymorph |
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-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ( (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
implies code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).exists())
and (classification.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and
code = 'C17021'
).exists() implies code.where(
code.coding.exists(system = 'https://www.uniprot.org')
).exists()) )cmc-name-isbt: Name.type ISBT 128 required for blood products. ( classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy') )cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. ( classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists() )cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ( (classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7] 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 | Substance TypeA 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..1* |
Binding | The codes SHALL be taken from For codes, see Substance Classification (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification ) |
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.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 | 10..1* |
Type | Reference(Literal Reference)(Basic Organization, Organization)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())) |
14. 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..1* |
Type | Reference(Literal Reference)(Basic Organization, Organization)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())) |
16. 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. [Source: Merriam Webster] 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 | Molecular WeightThe average mass of a molecule of a compound |
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())) |
18. 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()) |
20. 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 |
Binding | Unless not suitable, these codes SHALL be taken from For codes, see Units Of Measure (extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure ) |
Type | Quantity |
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())) |
22. SubstanceDefinition.molecularWeight.amount.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. SubstanceDefinition.molecularWeight.amount.unit | |
Definition | The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055] A human-readable form of the unit. |
Short | Molecular Weight UOMUnit representation |
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 | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
26. SubstanceDefinition.molecularWeight.amount.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 10..1 This element is affected by the following invariants: qty-3 |
Type | code |
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 a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
28. SubstanceDefinition.structure | |
Definition | Structural information. |
Short | Structural information |
Control | 10..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cmc-structure-representation-required: Either a file or string structure representation is required ( representation.type.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'
and (code in ('C45253' | 'C103240'))
).exists() ) |
30. 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()) |
32. SubstanceDefinition.structure.molecularFormula | |
Definition | Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD An expression which states the number and type of atoms present in a molecule of a substance. |
Short | Molecular Formula | Biopolymer SequenceAn expression which states the number and type of atoms present in a molecule of a substance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
34. SubstanceDefinition.structure.technique | |
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay. The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay. |
Short | Substance Characterisation TechniqueThe method used to find the structure e.g. X-ray, NMR |
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 | 10..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 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())) |
36. 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 | 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())) |
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: |
38. 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()) |
40. 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())) |
42. 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())) |
44. 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()) |
46. 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())) |
48. 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())) |
50. 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())) |
52. 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()) |
54. 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())) |
56. 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())) |
58. 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())) |
60. 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()) |
62. 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())) |
64. 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())) |
66. 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())) |
68. SubstanceDefinition.code | |
Definition | Codes associated with the substance. |
Short | Codes associated with the 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())) |
Slicing | This element introduces a set of slices on SubstanceDefinition.code . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
70. 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()) |
72. 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())) |
74. 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()) |
76. 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())) |
78. 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())) |
80. 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())) |
82. 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())) |
84. 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()) |
86. 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())) |
88. 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())) |
90. 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())) |
92. SubstanceDefinition.name | |
Definition | Substance Name is identified by its Substance Type. Substance 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 | Subtance 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: |
94. 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()) |
96. 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())) |
98. 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())) |
100. 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())) |
102. SubstanceDefinition.name:sys | |
Slice Name | sys |
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())) |
104. SubstanceDefinition.name:sys.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.name:sys.name | |
Definition | A name derived directly from the chemical structure. [Source: SME Defined] The actual name. |
Short | SystematicThe 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())) |
108. SubstanceDefinition.name:sys.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())) |
110. SubstanceDefinition.name:sys.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())) |
112. 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())) |
114. 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()) |
116. SubstanceDefinition.name:sub.name | |
Definition | A non-branded nor registered name that meant for common use. The actual name. |
Short | GenericThe 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())) |
118. 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())) |
120. 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())) |
122. SubstanceDefinition.name:brand | |
Slice Name | brand |
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())) |
124. SubstanceDefinition.name:brand.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()) |
126. SubstanceDefinition.name:brand.name | |
Definition | The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies. The actual name. |
Short | BrandThe 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())) |
128. SubstanceDefinition.name:brand.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())) |
130. SubstanceDefinition.name:brand.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())) |
132. 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())) |
134. 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()) |
136. 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())) |
138. 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())) |
140. 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())) |
142. SubstanceDefinition.name:usp | |
Slice Name | usp |
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())) |
144. SubstanceDefinition.name:usp.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()) |
146. SubstanceDefinition.name:usp.name | |
Definition | A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined] The actual name. |
Short | USP-NF Established 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())) |
148. SubstanceDefinition.name:usp.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())) |
150. SubstanceDefinition.name:usp.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())) |
152. SubstanceDefinition.name:cas | |
Slice Name | cas |
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())) |
154. SubstanceDefinition.name:cas.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()) |
156. SubstanceDefinition.name:cas.name | |
Definition | Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org] Example: CAS [103-90-2] The actual name. |
Short | CAS NumberThe 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())) |
158. SubstanceDefinition.name:cas.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())) |
160. SubstanceDefinition.name:cas.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())) |
162. SubstanceDefinition.name:inn | |
Slice Name | inn |
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())) |
164. SubstanceDefinition.name:inn.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()) |
166. SubstanceDefinition.name:inn.name | |
Definition | International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol The actual name. |
Short | INNThe 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())) |
168. SubstanceDefinition.name:inn.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())) |
170. SubstanceDefinition.name:inn.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())) |
172. SubstanceDefinition.name:usan | |
Slice Name | usan |
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())) |
174. SubstanceDefinition.name:usan.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()) |
176. SubstanceDefinition.name:usan.name | |
Definition | A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen The actual name. |
Short | USANThe 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())) |
178. SubstanceDefinition.name:usan.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())) |
180. SubstanceDefinition.name:usan.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())) |
182. SubstanceDefinition.name:iupac | |
Slice Name | iupac |
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())) |
184. SubstanceDefinition.name:iupac.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
186. SubstanceDefinition.name:iupac.name | |
Definition | A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined] Example: N- (4-hydroxyphenyl)acetamide The actual name. |
Short | IUPAC 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())) |
188. SubstanceDefinition.name:iupac.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())) |
190. SubstanceDefinition.name:iupac.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())) |
192. 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())) |
194. 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()) |
196. 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())) |
198. 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())) |
200. 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())) |
202. 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())) |
204. 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()) |
206. 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())) |
208. 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())) |
210. 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 | 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())) |
212. 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 | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
214. 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()) |
216. SubstanceDefinition.relationship.substanceDefinition[x] | |
Definition | A pointer to another substance, as a resource or just a representational code. |
Short | The substance definition of a polyphorm of the Drug SubstanceA pointer to another substance, as a resource or a representational code |
Control | 0..1 |
Type | Reference(Literal Reference)(Polymorphic Form, SubstanceDefinition)bundled, 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())) |
218. SubstanceDefinition.relationship.type | |
Definition | A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text. For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of". |
Short | PolymorphFor example "salt to parent", "active moiety" |
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 | 1..1 |
Binding | For example codes, see SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type (example to http://hl7.org/fhir/ValueSet/substance-relationship-type )The relationship between two substance types. |
Type | CodeableConcept(Text Only Codeable Concept) |
Is Modifier | false |
Must Support | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
220. SubstanceDefinition.relationship.type.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 | 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 |
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. |
Pattern Value | Polymorph |
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-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ( (classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
implies code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).exists())
and (classification.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and
code = 'C17021'
).exists() implies code.where(
code.coding.exists(system = 'https://www.uniprot.org')
).exists()) )cmc-name-isbt: Name.type ISBT 128 required for blood products. ( classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy') )cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. ( classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists() )cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. ( (classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7] |
Short | Substance Type |
Control | 1..1 |
Binding | The codes SHALL be taken from Substance Classification (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification ) |
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 | 1..1 |
Type | Reference(Literal Reference)(Basic Organization)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()) ) |
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..1 |
Type | Reference(Literal Reference)(Basic Organization)bundled |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
40. SubstanceDefinition.moiety | |
Definition | Moiety, for structural modifications. |
Short | Moiety, for structural modifications |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
42. SubstanceDefinition.moiety.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
44. SubstanceDefinition.moiety.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
46. SubstanceDefinition.moiety.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
48. SubstanceDefinition.moiety.role | |
Definition | Role that the moiety is playing. |
Short | Role that the moiety is playing |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
50. SubstanceDefinition.moiety.identifier | |
Definition | Identifier by which this moiety substance is known. |
Short | Identifier by which this moiety substance is known |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
52. SubstanceDefinition.moiety.name | |
Definition | Textual name for this moiety substance. |
Short | Textual name for this moiety substance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
54. SubstanceDefinition.moiety.stereochemistry | |
Definition | Stereochemistry type. |
Short | Stereochemistry type |
Control | 0..1 |
Binding | For example codes, see Stereochemistry (example to http://hl7.org/fhir/ValueSet/substance-stereochemistry )The optical rotation type of a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. SubstanceDefinition.moiety.opticalActivity | |
Definition | Optical activity type. |
Short | Optical activity type |
Control | 0..1 |
Binding | For example codes, see OpticalActivity (example to http://hl7.org/fhir/ValueSet/substance-optical-activity )The optical rotation type of a substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
58. SubstanceDefinition.moiety.molecularFormula | |
Definition | Molecular formula for this moiety of this substance, typically using the Hill system. |
Short | Molecular formula for this moiety (e.g. with the Hill system) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
60. SubstanceDefinition.moiety.amount[x] | |
Definition | Quantitative value for this moiety. |
Short | Quantitative value for this moiety |
Control | 0..1 |
Type | Choice of: Quantity, string |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. SubstanceDefinition.moiety.measurementType | |
Definition | The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio. |
Short | The measurement type of the quantitative value |
Control | 0..1 |
Binding | For example codes, see SubstanceAmountType (example to http://hl7.org/fhir/ValueSet/substance-amount-type )The relationship between two substance types. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. SubstanceDefinition.characterization | |
Definition | General specifications for this substance. |
Short | General specifications for this substance |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. SubstanceDefinition.characterization.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
68. SubstanceDefinition.characterization.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
70. SubstanceDefinition.characterization.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
72. SubstanceDefinition.characterization.technique | |
Definition | The method used to elucidate the characterization of the drug substance. Example: HPLC. |
Short | The method used to find the characterization e.g. HPLC |
Control | 0..1 |
Binding | For example codes, see StructureTechnique (example to http://hl7.org/fhir/ValueSet/substance-structure-technique )The method used to elucidate the characterization of the drug substance. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
74. SubstanceDefinition.characterization.form | |
Definition | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form. |
Short | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form |
Control | 0..1 |
Binding | For example codes, see SubstanceForm (example to http://hl7.org/fhir/ValueSet/substance-form ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. SubstanceDefinition.characterization.description | |
Definition | The description or justification in support of the interpretation of the data file. |
Short | The description or justification in support of the interpretation of the data file |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
78. SubstanceDefinition.characterization.file | |
Definition | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis. |
Short | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis |
Control | 0..* |
Type | Attachment |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
80. SubstanceDefinition.property | |
Definition | General specifications for this substance. |
Short | General specifications for this substance |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. SubstanceDefinition.property.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
84. SubstanceDefinition.property.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
86. SubstanceDefinition.property.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
88. SubstanceDefinition.property.type | |
Definition | A code expressing the type of property. |
Short | A code expressing the type of property |
Control | 1..1 |
Binding | For example codes, see ProductCharacteristic (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes )This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. SubstanceDefinition.property.value[x] | |
Definition | A value for the property. |
Short | A value for the property |
Control | 0..1 |
Type | Choice of: CodeableConcept, Quantity, date, boolean, Attachment |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
92. SubstanceDefinition.referenceInformation | |
Definition | General information detailing this substance. |
Short | General information detailing this substance |
Control | 0..1 |
Type | Reference(SubstanceReferenceInformation) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. SubstanceDefinition.molecularWeight | |
Definition | The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster] |
Short | Molecular Weight |
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()) ) |
96. SubstanceDefinition.molecularWeight.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
98. SubstanceDefinition.molecularWeight.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
100. SubstanceDefinition.molecularWeight.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
102. SubstanceDefinition.molecularWeight.method | |
Definition | The method by which the molecular weight was determined. |
Short | The method by which the weight was determined |
Control | 0..1 |
Binding | For example codes, see WeightMethod (example to http://hl7.org/fhir/ValueSet/substance-weight-method )The method by which the substance weight was measured. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
104. SubstanceDefinition.molecularWeight.type | |
Definition | Type of molecular weight such as exact, average (also known as. number average), weight average. |
Short | Type of molecular weight e.g. exact, average, weight average |
Control | 0..1 |
Binding | For example codes, see WeightType (example to http://hl7.org/fhir/ValueSet/substance-weight-type )The type of substance weight measurement. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
106. SubstanceDefinition.molecularWeight.amount | |
Definition | Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field. |
Short | Used to capture quantitative values for a variety of elements |
Control | 1..1 |
Binding | Unless not suitable, these codes SHALL be taken from Units Of Measure (extensible to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure ) |
Type | Quantity |
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()) ) |
108. SubstanceDefinition.molecularWeight.amount.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 |
110. SubstanceDefinition.molecularWeight.amount.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.molecularWeight.amount.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
112. SubstanceDefinition.molecularWeight.amount.value | |
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Numerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 0..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
114. SubstanceDefinition.molecularWeight.amount.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
116. SubstanceDefinition.molecularWeight.amount.unit | |
Definition | The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055] |
Short | Molecular Weight UOM |
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 | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
118. SubstanceDefinition.molecularWeight.amount.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to know the system that defines the coded form of the unit. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. SubstanceDefinition.molecularWeight.amount.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 1..1 This element is affected by the following invariants: qty-3 |
Type | code |
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 a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
122. SubstanceDefinition.structure | |
Definition | Structural information. |
Short | Structural information |
Control | 1..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )cmc-structure-representation-required: Either a file or string structure representation is required ( representation.type.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'
and (code in ('C45253' | 'C103240'))
).exists() ) |
124. 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 |
126. 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() ) |
128. 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() ) |
130. 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()) ) |
132. 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()) ) |
134. SubstanceDefinition.structure.molecularFormula | |
Definition | Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined] Biopolymer Sequence: TBD |
Short | Molecular Formula | Biopolymer Sequence |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
136. 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()) ) |
138. 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()) ) |
140. SubstanceDefinition.structure.technique | |
Definition | The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay. |
Short | Substance Characterisation Technique |
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 | 1..1 |
Binding | For example codes, see StructureTechnique (example to http://hl7.org/fhir/ValueSet/substance-structure-technique )The method used to elucidate the structure of the drug substance. |
Type | CodeableConcept(Text Only Codeable Concept) |
Is Modifier | false |
Must Support | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. 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()) ) |
144. SubstanceDefinition.structure.representation | |
Definition | A depiction of the structure of the substance. |
Short | Impurity Structure Graphic | Impurity Structure Data File |
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()) ) |
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: |
146. 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 |
148. 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() ) |
150. 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() ) |
152. 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()) ) |
154. 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()) ) |
156. 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()) ) |
158. 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()) ) |
160. 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()) ) |
162. 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 |
164. 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() ) |
166. 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() ) |
168. 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()) ) |
170. 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()) ) |
172. 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()) ) |
174. 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()) ) |
176. 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()) ) |
178. 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 |
180. 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() ) |
182. 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() ) |
184. 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()) ) |
186. 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()) ) |
188. 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()) ) |
190. 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()) ) |
192. 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()) ) |
194. 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 |
196. 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() ) |
198. 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() ) |
200. 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()) ) |
202. 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()) ) |
204. 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()) ) |
206. 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()) ) |
208. SubstanceDefinition.code | |
Definition | Codes associated with the substance. |
Short | Codes associated with the substance |
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()) ) |
Slicing | This element introduces a set of slices on SubstanceDefinition.code . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
210. 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 |
212. 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() ) |
214. 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() ) |
216. 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()) ) |
218. 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()) ) |
220. 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()) ) |
222. 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()) ) |
224. 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()) ) |
226. 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()) ) |
228. 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 |
230. 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() ) |
232. 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() ) |
234. 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()) ) |
236. 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 |
238. 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: |
240. 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()) ) |
242. 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 |
244. 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: |
246. 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()) ) |
248. 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()) ) |
250. 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()) ) |
252. 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()) ) |
254. 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()) ) |
256. 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()) ) |
258. 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()) ) |
260. 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()) ) |
262. 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()) ) |
264. 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()) ) |
266. 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()) ) |
268. 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 |
270. 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() ) |
272. 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() ) |
274. 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()) ) |
276. 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 |
278. 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: |
280. 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()) ) |
282. 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 |
284. 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: |
286. 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()) ) |
288. 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()) ) |
290. 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()) ) |
292. 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()) ) |
294. 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()) ) |
296. 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()) ) |
298. 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()) ) |
300. 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()) ) |
302. 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()) ) |
304. 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()) ) |
306. SubstanceDefinition.name | |
Definition | Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF |
Short | Subtance 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: |
308. 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 |
310. 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() ) |
312. 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() ) |
314. 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()) ) |
316. 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()) ) |
318. 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()) ) |
320. 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()) ) |
322. 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()) ) |
324. 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()) ) |
326. 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()) ) |
328. 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()) ) |
330. 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()) ) |
332. 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 |