Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form | Version: 0.1.20 | |||
| Draft as of 2024-03-04 | Computable Name: PolymorphicForm | |||
Alternate structure present in the drug substance
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from SubstanceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  SubstanceDefinition | SubstanceDefinition | |||
  meta | ||||
  profile | S | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 identifier | S | 0..1 | Identifier | optional user designated identifier |
| structure | S | 0..1 | BackboneElement | Structural information |
| molecularFormula | S | 0..1 | string | Molecular Formula |
| technique | S | 0..1 | CodeableConcept | Substance Characterization Technique |
| text | S | 1..1 | string | Plain text representation of the concept |
 representation | S | 1..* | BackboneElement | A depiction of the structure of the substance |
 representation | S | 0..1 | string | Structural Representation |
| format | S | 0..1 | CodeableConcept | Structural Representation Type |
| coding | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) | |
 document | S | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | S | 0..1 | BackboneElement | Codes associated with the substance |
| code | ||||
| coding | 0..* | Coding | UNII | |
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://gsrs.ncats.nih.gov | |
 Slices for name | SC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
 name:All Slices | Content/Rules for all slices | |||
  preferred | S | 0..1 | boolean | True when the name type is Substance Name |
 name:sub | S | 0..1 | BackboneElement | Names applicable to this substance |
 name | S | 1..1 | string | Generic Name |
 type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
 coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
 system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |
 preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
| name:gsrs | S | 0..1 | BackboneElement | Names applicable to this substance |
| name | S | 1..1 | string | GSRS Preferred Term |
| type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
| coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |
| preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
 name:isbt | S | 0..1 | BackboneElement | Names applicable to this substance |
| name | S | 1..1 | string | ISBT-128 DIN |
| type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
| coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |
| preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
 meta | Σ | 0..1 | Meta | Metadata about the resource |
 profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier |
| structure | SΣ | 0..1 | BackboneElement | Structural information |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| molecularFormula | SΣ | 0..1 | string | Molecular Formula |
| technique | SΣ | 0..1 | CodeableConcept | Substance Characterization Technique Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. |
| text | SΣ | 1..1 | string | Plain text representation of the concept |
| representation | SΣ | 1..* | BackboneElement | A depiction of the structure of the substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| representation | SΣ | 0..1 | string | Structural Representation |
| format | SΣ | 0..1 | CodeableConcept | Structural Representation Type Binding: SubstanceRepresentationFormat (example): A format of a substance representation. |
| coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) |
| document | SΣ | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | SΣ | 0..1 | BackboneElement | Codes associated with the substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Slices for name | SΣC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
| name:All Slices | Content/Rules for all slices | |||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| preferred | SΣ | 0..1 | boolean | True when the name type is Substance Name |
| name:sub | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | Generic Name |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| name:gsrs | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | GSRS Preferred Term |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| name:isbt | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | ISBT-128 DIN |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-formatfrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG | |
| SubstanceDefinition.name:sub.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 | |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
 extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId | Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
| source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier | ||||
| version | Σ | 0..1 | string | A business level version identifier of the substance | ||||
| status | Σ | 0..1 | CodeableConcept | Status of substance within the catalogue e.g. active, retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| classification | Σ | 0..* | CodeableConcept | A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity | ||||
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary). | ||||
| grade | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies | ||||
| description | Σ | 0..1 | markdown | Textual description of the substance | ||||
| informationSource | Σ | 0..* | Reference(Citation) | Supporting literature | ||||
| note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record | ||||
| manufacturer | Σ | 0..* | Reference(Organization) | The entity that creates, makes, produces or fabricates the substance | ||||
| supplier | Σ | 0..* | Reference(Organization) | An entity that is the source for the substance. It may be different from the manufacturer | ||||
| moiety | Σ | 0..* | BackboneElement | Moiety, for structural modifications | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| role | Σ | 0..1 | CodeableConcept | Role that the moiety is playing | ||||
| identifier | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known | ||||
| name | Σ | 0..1 | string | Textual name for this moiety substance | ||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
| molecularFormula | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) | ||||
 amount[x] | Σ | 0..1 | Quantitative value for this moiety | |||||
| amountQuantity | Quantity | |||||||
| amountString | string | |||||||
| measurementType | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: SubstanceAmountType (example): The relationship between two substance types. | ||||
| characterization | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| technique | Σ | 0..1 | CodeableConcept | The method used to find the characterization e.g. HPLC Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance. | ||||
| form | Σ | 0..1 | CodeableConcept | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: SubstanceForm (example) | ||||
| description | Σ | 0..1 | markdown | The description or justification in support of the interpretation of the data file | ||||
| file | Σ | 0..* | Attachment | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis | ||||
| property | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
| value[x] | Σ | 0..1 | A value for the property | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueQuantity | Quantity | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| referenceInformation | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance | ||||
| molecularWeight | Σ | 0..* | BackboneElement | The average mass of a molecule of a compound | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. | ||||
| type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. | ||||
| amount | Σ | 1..1 | Quantity | Used to capture quantitative values for a variety of elements | ||||
| structure | SΣ | 0..1 | BackboneElement | Structural information | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
| molecularFormula | SΣ | 0..1 | string | Molecular Formula | ||||
| molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system | ||||
| molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range | ||||
| technique | SΣ | 0..1 | CodeableConcept | Substance Characterization Technique Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | ||||
| sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | ||||
| representation | SΣ | 1..* | BackboneElement | A depiction of the structure of the substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. | ||||
| representation | SΣ | 0..1 | string | Structural Representation | ||||
| format | SΣ | 0..1 | CodeableConcept | Structural Representation Type Binding: SubstanceRepresentationFormat (example): A format of a substance representation. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| document | SΣ | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file | ||||
| code | SΣ | 0..1 | BackboneElement | Codes associated with the substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | Σ | 0..1 | CodeableConcept | The specific code | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | UNII | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: https://gsrs.ncats.nih.gov | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | ΣC | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the code status was changed | ||||
| note | Σ | 0..* | Annotation | Any comment can be provided in this field | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| Slices for name | SΣC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true | ||||
| name:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | Σ | 1..1 | string | The actual name | ||||
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | True when the name type is Substance Name | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:sub | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | Generic Name | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:gsrs | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | GSRS Preferred Term | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:isbt | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | ISBT-128 DIN | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| relationship | Σ | 0..* | BackboneElement | A link between this substance and another | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| substanceDefinition[x] | Σ | 0..1 | A pointer to another substance, as a resource or a representational code | |||||
| substanceDefinitionReference | Reference(SubstanceDefinition) | |||||||
| substanceDefinitionCodeableConcept | CodeableConcept | |||||||
| type | Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types. | ||||
| isDefining | Σ | 0..1 | boolean | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships | ||||
| amount[x] | Σ | 0..1 | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | |||||
| amountQuantity | Quantity | |||||||
| amountRatio | Ratio | |||||||
| amountString | string | |||||||
| ratioHighLimitAmount | Σ | 0..1 | Ratio | For use when the numeric has an uncertain range | ||||
| comparator | Σ | 0..1 | CodeableConcept | An operator for the amount, for example "average", "approximately", "less than" Binding: SubstanceAmountType (example): The relationship between two substance types. | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| nucleicAcid | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids | ||||
| polymer | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers | ||||
| protein | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins | ||||
| sourceMaterial | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | Classification of the origin of the raw material. e.g. cat hair is an Animal source type Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material. | ||||
| genus | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. | ||||
| species | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: SourceMaterialSpecies (example): A species of origin a substance raw material. | ||||
| part | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. | ||||
| countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| SubstanceDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| SubstanceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| SubstanceDefinition.grade | example | SubstanceGradehttp://hl7.org/fhir/ValueSet/substance-gradefrom the FHIR Standard | |
| SubstanceDefinition.moiety.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistryfrom the FHIR Standard | |
| SubstanceDefinition.moiety.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activityfrom the FHIR Standard | |
| SubstanceDefinition.moiety.measurementType | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-typefrom the FHIR Standard | |
| SubstanceDefinition.characterization.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.characterization.form | example | SubstanceFormhttp://hl7.org/fhir/ValueSet/substance-formfrom the FHIR Standard | |
| SubstanceDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| SubstanceDefinition.molecularWeight.method | example | WeightMethodhttp://hl7.org/fhir/ValueSet/substance-weight-methodfrom the FHIR Standard | |
| SubstanceDefinition.molecularWeight.type | example | WeightTypehttp://hl7.org/fhir/ValueSet/substance-weight-typefrom the FHIR Standard | |
| SubstanceDefinition.structure.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistryfrom the FHIR Standard | |
| SubstanceDefinition.structure.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activityfrom the FHIR Standard | |
| SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-typefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-formatfrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG | |
| SubstanceDefinition.code.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:sub.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:sub.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:gsrs.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:isbt.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.relationship.type | example | SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-typefrom the FHIR Standard | |
| SubstanceDefinition.relationship.comparator | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-typefrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.type | example | SourceMaterialTypehttp://hl7.org/fhir/ValueSet/substance-source-material-typefrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenushttp://hl7.org/fhir/ValueSet/substance-source-material-genusfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecieshttp://hl7.org/fhir/ValueSet/substance-source-material-speciesfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.part | example | SourceMaterialParthttp://hl7.org/fhir/ValueSet/substance-source-material-partfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSethttp://hl7.org/fhir/ValueSet/country|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 | |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 1 element (8 nested mandatory elements)
Must-Support: 28 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from SubstanceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | SubstanceDefinition | |||
| meta | ||||
| profile | S | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| identifier | S | 0..1 | Identifier | optional user designated identifier |
| structure | S | 0..1 | BackboneElement | Structural information |
| molecularFormula | S | 0..1 | string | Molecular Formula |
| technique | S | 0..1 | CodeableConcept | Substance Characterization Technique |
| text | S | 1..1 | string | Plain text representation of the concept |
| representation | S | 1..* | BackboneElement | A depiction of the structure of the substance |
| representation | S | 0..1 | string | Structural Representation |
| format | S | 0..1 | CodeableConcept | Structural Representation Type |
| coding | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) | |
| document | S | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | S | 0..1 | BackboneElement | Codes associated with the substance |
| code | ||||
| coding | 0..* | Coding | UNII | |
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://gsrs.ncats.nih.gov | |
| Slices for name | SC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
| name:All Slices | Content/Rules for all slices | |||
| preferred | S | 0..1 | boolean | True when the name type is Substance Name |
| name:sub | S | 0..1 | BackboneElement | Names applicable to this substance |
| name | S | 1..1 | string | Generic Name |
| type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
| coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |
| preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
| name:gsrs | S | 0..1 | BackboneElement | Names applicable to this substance |
| name | S | 1..1 | string | GSRS Preferred Term |
| type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
| coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |
| preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
| name:isbt | S | 0..1 | BackboneElement | Names applicable to this substance |
| name | S | 1..1 | string | ISBT-128 DIN |
| type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' |
| coding | S | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |
| preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier |
| structure | SΣ | 0..1 | BackboneElement | Structural information |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| molecularFormula | SΣ | 0..1 | string | Molecular Formula |
| technique | SΣ | 0..1 | CodeableConcept | Substance Characterization Technique Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. |
| text | SΣ | 1..1 | string | Plain text representation of the concept |
| representation | SΣ | 1..* | BackboneElement | A depiction of the structure of the substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| representation | SΣ | 0..1 | string | Structural Representation |
| format | SΣ | 0..1 | CodeableConcept | Structural Representation Type Binding: SubstanceRepresentationFormat (example): A format of a substance representation. |
| coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) |
| document | SΣ | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | SΣ | 0..1 | BackboneElement | Codes associated with the substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Slices for name | SΣC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
| name:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| preferred | SΣ | 0..1 | boolean | True when the name type is Substance Name |
| name:sub | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | Generic Name |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| name:gsrs | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | GSRS Preferred Term |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| name:isbt | SΣ | 0..1 | BackboneElement | Names applicable to this substance |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | SΣ | 1..1 | string | ISBT-128 DIN |
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-formatfrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG | |
| SubstanceDefinition.name:sub.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 | |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId | Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
| source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile | SΣ | 0..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | SΣ | 0..1 | Identifier | optional user designated identifier | ||||
| version | Σ | 0..1 | string | A business level version identifier of the substance | ||||
| status | Σ | 0..1 | CodeableConcept | Status of substance within the catalogue e.g. active, retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| classification | Σ | 0..* | CodeableConcept | A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity | ||||
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary). | ||||
| grade | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies | ||||
| description | Σ | 0..1 | markdown | Textual description of the substance | ||||
| informationSource | Σ | 0..* | Reference(Citation) | Supporting literature | ||||
| note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record | ||||
| manufacturer | Σ | 0..* | Reference(Organization) | The entity that creates, makes, produces or fabricates the substance | ||||
| supplier | Σ | 0..* | Reference(Organization) | An entity that is the source for the substance. It may be different from the manufacturer | ||||
| moiety | Σ | 0..* | BackboneElement | Moiety, for structural modifications | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| role | Σ | 0..1 | CodeableConcept | Role that the moiety is playing | ||||
| identifier | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known | ||||
| name | Σ | 0..1 | string | Textual name for this moiety substance | ||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
| molecularFormula | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) | ||||
| amount[x] | Σ | 0..1 | Quantitative value for this moiety | |||||
| amountQuantity | Quantity | |||||||
| amountString | string | |||||||
| measurementType | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: SubstanceAmountType (example): The relationship between two substance types. | ||||
| characterization | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| technique | Σ | 0..1 | CodeableConcept | The method used to find the characterization e.g. HPLC Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance. | ||||
| form | Σ | 0..1 | CodeableConcept | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: SubstanceForm (example) | ||||
| description | Σ | 0..1 | markdown | The description or justification in support of the interpretation of the data file | ||||
| file | Σ | 0..* | Attachment | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis | ||||
| property | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
| value[x] | Σ | 0..1 | A value for the property | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueQuantity | Quantity | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| referenceInformation | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance | ||||
| molecularWeight | Σ | 0..* | BackboneElement | The average mass of a molecule of a compound | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. | ||||
| type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. | ||||
| amount | Σ | 1..1 | Quantity | Used to capture quantitative values for a variety of elements | ||||
| structure | SΣ | 0..1 | BackboneElement | Structural information | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
| molecularFormula | SΣ | 0..1 | string | Molecular Formula | ||||
| molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system | ||||
| molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range | ||||
| technique | SΣ | 0..1 | CodeableConcept | Substance Characterization Technique Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | SΣ | 1..1 | string | Plain text representation of the concept | ||||
| sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | ||||
| representation | SΣ | 1..* | BackboneElement | A depiction of the structure of the substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. | ||||
| representation | SΣ | 0..1 | string | Structural Representation | ||||
| format | SΣ | 0..1 | CodeableConcept | Structural Representation Type Binding: SubstanceRepresentationFormat (example): A format of a substance representation. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Chemical Structure Data File Type Terminology (required) | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| document | SΣ | 0..1 | Reference(Document Reference Attachment) | An attachment with the structural representation e.g. a structure graphic or AnIML file | ||||
| code | SΣ | 0..1 | BackboneElement | Codes associated with the substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | Σ | 0..1 | CodeableConcept | The specific code | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | UNII | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: https://gsrs.ncats.nih.gov | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | ΣC | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the code status was changed | ||||
| note | Σ | 0..* | Annotation | Any comment can be provided in this field | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| Slices for name | SΣC | 1..* | BackboneElement | Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true | ||||
| name:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | Σ | 1..1 | string | The actual name | ||||
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | True when the name type is Substance Name | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:sub | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | Generic Name | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:gsrs | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | GSRS Preferred Term | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| name:isbt | SΣ | 0..1 | BackboneElement | Names applicable to this substance | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name | SΣ | 1..1 | string | ISBT-128 DIN | ||||
| type | SΣ | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | SΣ | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C95517 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: ISBT-128 DIN | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| preferred | SΣ | 0..1 | boolean | If this is the preferred name for this substance | ||||
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language
| ||||
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. | ||||
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| date | Σ | 0..1 | dateTime | Date of official name change | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| relationship | Σ | 0..* | BackboneElement | A link between this substance and another | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| substanceDefinition[x] | Σ | 0..1 | A pointer to another substance, as a resource or a representational code | |||||
| substanceDefinitionReference | Reference(SubstanceDefinition) | |||||||
| substanceDefinitionCodeableConcept | CodeableConcept | |||||||
| type | Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types. | ||||
| isDefining | Σ | 0..1 | boolean | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships | ||||
| amount[x] | Σ | 0..1 | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | |||||
| amountQuantity | Quantity | |||||||
| amountRatio | Ratio | |||||||
| amountString | string | |||||||
| ratioHighLimitAmount | Σ | 0..1 | Ratio | For use when the numeric has an uncertain range | ||||
| comparator | Σ | 0..1 | CodeableConcept | An operator for the amount, for example "average", "approximately", "less than" Binding: SubstanceAmountType (example): The relationship between two substance types. | ||||
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature | ||||
| nucleicAcid | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids | ||||
| polymer | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers | ||||
| protein | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins | ||||
| sourceMaterial | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | Classification of the origin of the raw material. e.g. cat hair is an Animal source type Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material. | ||||
| genus | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. | ||||
| species | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: SourceMaterialSpecies (example): A species of origin a substance raw material. | ||||
| part | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. | ||||
| countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| SubstanceDefinition.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| SubstanceDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| SubstanceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| SubstanceDefinition.grade | example | SubstanceGradehttp://hl7.org/fhir/ValueSet/substance-gradefrom the FHIR Standard | |
| SubstanceDefinition.moiety.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistryfrom the FHIR Standard | |
| SubstanceDefinition.moiety.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activityfrom the FHIR Standard | |
| SubstanceDefinition.moiety.measurementType | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-typefrom the FHIR Standard | |
| SubstanceDefinition.characterization.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.characterization.form | example | SubstanceFormhttp://hl7.org/fhir/ValueSet/substance-formfrom the FHIR Standard | |
| SubstanceDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| SubstanceDefinition.molecularWeight.method | example | WeightMethodhttp://hl7.org/fhir/ValueSet/substance-weight-methodfrom the FHIR Standard | |
| SubstanceDefinition.molecularWeight.type | example | WeightTypehttp://hl7.org/fhir/ValueSet/substance-weight-typefrom the FHIR Standard | |
| SubstanceDefinition.structure.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistryfrom the FHIR Standard | |
| SubstanceDefinition.structure.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activityfrom the FHIR Standard | |
| SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-techniquefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-typefrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-formatfrom the FHIR Standard | |
| SubstanceDefinition.structure.representation.format.coding | required | PqcmcChemicalStructureDataFileTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminologyfrom this IG | |
| SubstanceDefinition.code.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:sub.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:sub.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:sub.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:gsrs.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:gsrs.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-typefrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| SubstanceDefinition.name:isbt.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domainfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authorityfrom the FHIR Standard | |
| SubstanceDefinition.name:isbt.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| SubstanceDefinition.relationship.type | example | SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-typefrom the FHIR Standard | |
| SubstanceDefinition.relationship.comparator | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-typefrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.type | example | SourceMaterialTypehttp://hl7.org/fhir/ValueSet/substance-source-material-typefrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenushttp://hl7.org/fhir/ValueSet/substance-source-material-genusfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecieshttp://hl7.org/fhir/ValueSet/substance-source-material-speciesfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.part | example | SourceMaterialParthttp://hl7.org/fhir/ValueSet/substance-source-material-partfrom the FHIR Standard | |
| SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSethttp://hl7.org/fhir/ValueSet/country|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-name-preferred | error | SubstanceDefinition.name | Name.preferred: at most one = true : select(preferred = true).count() < 2 | |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | 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 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 1 element (8 nested mandatory elements)
Must-Support: 28 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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