{
"description": "Alternate structure present in the drug substance",
"_filename": "StructureDefinition-pqcmc-polymorphic-form.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"date": "2024-12-11T13:47:08+00:00",
"derivation": "constraint",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"name": "PolymorphicForm",
"mapping": [ {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
}, {
"uri": "https://www.iso.org/obp/ui/#iso:std:iso:11238",
"name": "IDMP Mapping (Substance)",
"identity": "idmp-substance"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"type": "SubstanceDefinition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "Polymorphic Form",
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"human": "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",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "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()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
} ],
"expression": "text.`div`.exists()"
} ],
"path": "SubstanceDefinition",
"min": 0,
"definition": "The detailed description of a substance, typically at a level beyond what is used for prescribing.",
"isModifier": false,
"short": "The detailed description of a substance, typically at a level beyond what is used for prescribing",
"mapping": [ {
"map": "Entity, Role, or Act",
"identity": "rim"
}, {
"map": "administrative.medication",
"identity": "w5"
}, {
"map": "Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)",
"identity": "idmp-substance"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition"
},
"isSummary": false
}, {
"path": "SubstanceDefinition.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"isModifier": false,
"short": "Logical id of this artifact",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.id",
"comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.meta",
"min": 0,
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"isModifier": false,
"short": "Metadata about the resource",
"type": [ {
"code": "Meta"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.implicitRules",
"min": 0,
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"isModifier": true,
"short": "A set of rules under which this content was created",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.implicitRules",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.implicitRules"
},
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "SubstanceDefinition.language",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"base": {
"max": "1",
"min": 0,
"path": "Resource.language"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.text",
"min": 0,
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"isModifier": false,
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "SubstanceDefinition.text",
"condition": [ "dom-6" ],
"comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"base": {
"max": "1",
"min": 0,
"path": "DomainResource.text"
},
"isSummary": false
}, {
"path": "SubstanceDefinition.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"isModifier": false,
"short": "Contained, inline Resources",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"mustSupport": false,
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "SubstanceDefinition.contained",
"condition": [ "dom-2", "dom-4", "dom-3", "dom-5" ],
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.contained"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.identifier",
"min": 0,
"definition": "Identifier by which this substance is known.",
"isModifier": false,
"short": "optional user designated identifier",
"mapping": [ {
"map": "Substance.Substance_Id",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.version",
"min": 0,
"definition": "A business level version identifier of the substance.",
"isModifier": false,
"short": "A business level version identifier of the substance",
"mapping": [ {
"map": "Version.Version_Number",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.version",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.status",
"min": 0,
"definition": "Status of substance within the catalogue e.g. active, retired.",
"isModifier": false,
"short": "Status of substance within the catalogue e.g. active, retired",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.classification",
"min": 0,
"definition": "A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).",
"isModifier": false,
"short": "A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity",
"mapping": [ {
"map": "Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.classification",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.classification"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.domain",
"min": 0,
"definition": "If the substance applies to human or veterinary use.",
"isModifier": false,
"short": "If the substance applies to human or veterinary use",
"mapping": [ {
"map": "Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-domain",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "MedicinalProductType"
} ],
"description": "Applicable domain for this product (e.g. human, veterinary)."
},
"max": "1",
"id": "SubstanceDefinition.domain",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.domain"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.grade",
"min": 0,
"definition": "The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).",
"isModifier": false,
"short": "The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)",
"mapping": [ {
"map": "Substance_Specified_Substance_Group_3.Grade",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-grade",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceGrade"
} ],
"description": "The quality standard, established benchmark, to which a substance complies"
},
"max": "*",
"id": "SubstanceDefinition.grade",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.grade"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.description",
"min": 0,
"definition": "Textual description of the substance.",
"isModifier": false,
"short": "Textual description of the substance",
"mapping": [ {
"map": "Substance.Comment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.description",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.description"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.informationSource",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Citation" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.informationSource",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.informationSource"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.note",
"min": 0,
"definition": "Textual comment about the substance's catalogue or registry record.",
"isModifier": false,
"short": "Textual comment about the substance's catalogue or registry record",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Annotation"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.note",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.note"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.manufacturer",
"min": 0,
"definition": "The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.",
"isModifier": false,
"short": "The entity that creates, makes, produces or fabricates the substance",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.manufacturer",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.manufacturer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.supplier",
"min": 0,
"definition": "An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.",
"isModifier": false,
"short": "An entity that is the source for the substance. It may be different from the manufacturer",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.supplier",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.supplier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety",
"min": 0,
"definition": "Moiety, for structural modifications.",
"isModifier": false,
"short": "Moiety, for structural modifications",
"mapping": [ {
"map": "Substance.Moiety",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.moiety",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.moiety"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.moiety.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.moiety.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.moiety.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.moiety.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.moiety.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.moiety.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.role",
"min": 0,
"definition": "Role that the moiety is playing.",
"isModifier": false,
"short": "Role that the moiety is playing",
"mapping": [ {
"map": "Moiety.Moiety_Role",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.moiety.role",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.role"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.identifier",
"min": 0,
"definition": "Identifier by which this moiety substance is known.",
"isModifier": false,
"short": "Identifier by which this moiety substance is known",
"mapping": [ {
"map": "Moiety.Moiety_Id",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.moiety.identifier",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.name",
"min": 0,
"definition": "Textual name for this moiety substance.",
"isModifier": false,
"short": "Textual name for this moiety substance",
"mapping": [ {
"map": "Moiety.Moiety_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.moiety.name",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.stereochemistry",
"min": 0,
"definition": "Stereochemistry type.",
"isModifier": false,
"short": "Stereochemistry type",
"mapping": [ {
"map": "Moiety.Stereochemistry",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-stereochemistry",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceStereochemistry"
} ],
"description": "The optical rotation type of a substance."
},
"max": "1",
"id": "SubstanceDefinition.moiety.stereochemistry",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.stereochemistry"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.opticalActivity",
"min": 0,
"definition": "Optical activity type.",
"isModifier": false,
"short": "Optical activity type",
"mapping": [ {
"map": "Moiety.Optical_Activity",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-optical-activity",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceOpticalActivity"
} ],
"description": "The optical rotation type of a substance."
},
"max": "1",
"id": "SubstanceDefinition.moiety.opticalActivity",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.opticalActivity"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.molecularFormula",
"min": 0,
"definition": "Molecular formula for this moiety of this substance, typically using the Hill system.",
"isModifier": false,
"short": "Molecular formula for this moiety (e.g. with the Hill system)",
"mapping": [ {
"map": "Moiety.Molecular_Formula",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.moiety.molecularFormula",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.molecularFormula"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.amount[x]",
"min": 0,
"definition": "Quantitative value for this moiety.",
"isModifier": false,
"short": "Quantitative value for this moiety",
"mapping": [ {
"map": "Moiety.Amount",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Quantity"
}, {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.moiety.amount[x]",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.amount[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.moiety.measurementType",
"min": 0,
"definition": "The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.",
"isModifier": false,
"short": "The measurement type of the quantitative value",
"mapping": [ {
"map": "Amount.Amount_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-amount-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceAmountType"
} ],
"description": "The relationship between two substance types."
},
"max": "1",
"id": "SubstanceDefinition.moiety.measurementType",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.moiety.measurementType"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.characterization",
"min": 0,
"definition": "General specifications for this substance.",
"isModifier": false,
"short": "General specifications for this substance",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.characterization",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.characterization"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.characterization.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.characterization.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.characterization.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.characterization.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.characterization.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.characterization.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.characterization.technique",
"min": 0,
"definition": "The method used to elucidate the characterization of the drug substance. Example: HPLC.",
"isModifier": false,
"short": "The method used to find the characterization e.g. HPLC",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-structure-technique",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceStructureTechnique"
} ],
"description": "The method used to elucidate the characterization of the drug substance."
},
"max": "1",
"id": "SubstanceDefinition.characterization.technique",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.characterization.technique"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.characterization.form",
"min": 0,
"definition": "Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.",
"isModifier": false,
"short": "Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-form",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceForm"
} ]
},
"max": "1",
"id": "SubstanceDefinition.characterization.form",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.characterization.form"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.characterization.description",
"min": 0,
"definition": "The description or justification in support of the interpretation of the data file.",
"isModifier": false,
"short": "The description or justification in support of the interpretation of the data file",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.characterization.description",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.characterization.description"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.characterization.file",
"min": 0,
"definition": "The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.",
"isModifier": false,
"short": "The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.characterization.file",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.characterization.file"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.property",
"min": 0,
"definition": "General specifications for this substance.",
"isModifier": false,
"short": "General specifications for this substance",
"mapping": [ {
"map": "Substance.Property",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.property",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.property"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.property.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.property.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.property.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.property.type",
"min": 1,
"definition": "A code expressing the type of property.",
"isModifier": false,
"short": "A code expressing the type of property",
"mapping": [ {
"map": "Property.Property_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SNOMEDCTCharacteristicCodes"
} ],
"description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."
},
"max": "1",
"id": "SubstanceDefinition.property.type",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.property.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.property.value[x]",
"min": 0,
"definition": "A value for the property.",
"isModifier": false,
"short": "A value for the property",
"mapping": [ {
"map": "Physical Characteristics, attribute's value",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
}, {
"code": "Quantity"
}, {
"code": "date"
}, {
"code": "boolean"
}, {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.property.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.property.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.referenceInformation",
"min": 0,
"definition": "General information detailing this substance.",
"isModifier": false,
"short": "General information detailing this substance",
"mapping": [ {
"map": "Reference_Information",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceReferenceInformation" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.referenceInformation",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.referenceInformation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.molecularWeight",
"min": 0,
"definition": "The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.",
"isModifier": false,
"short": "The average mass of a molecule of a compound",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.molecularWeight",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.molecularWeight"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.molecularWeight.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.molecularWeight.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.molecularWeight.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.molecularWeight.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.molecularWeight.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.molecularWeight.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.molecularWeight.method",
"min": 0,
"definition": "The method by which the molecular weight was determined.",
"isModifier": false,
"short": "The method by which the weight was determined",
"mapping": [ {
"map": "Molecular_Weight.Molecular_Weight_Method",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-weight-method",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceWeightMethod"
} ],
"description": "The method by which the substance weight was measured."
},
"max": "1",
"id": "SubstanceDefinition.molecularWeight.method",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.molecularWeight.method"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.molecularWeight.type",
"min": 0,
"definition": "Type of molecular weight such as exact, average (also known as. number average), weight average.",
"isModifier": false,
"short": "Type of molecular weight e.g. exact, average, weight average",
"mapping": [ {
"map": "Molecular_Weight.Molecular_Weight_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-weight-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceWeightType"
} ],
"description": "The type of substance weight measurement."
},
"max": "1",
"id": "SubstanceDefinition.molecularWeight.type",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.molecularWeight.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.molecularWeight.amount",
"min": 1,
"definition": "Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.",
"isModifier": false,
"short": "Used to capture quantitative values for a variety of elements",
"mapping": [ {
"map": "Molecular_Weight.Amount",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Quantity"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.molecularWeight.amount",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.molecularWeight.amount"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "cmc-structure-representation-required",
"human": "Either a file or string structure representation is required",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form",
"severity": "error",
"expression": "representation.type.coding.where(\n system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'\n and (code in ('C45253' | 'C103240'))\n).exists()"
} ],
"path": "SubstanceDefinition.structure",
"min": 0,
"definition": "Structural information.",
"isModifier": false,
"short": "Structural information",
"mapping": [ {
"map": "Substance.Structure",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.structure",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.structure.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.structure.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.structure.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.structure.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.stereochemistry",
"min": 0,
"definition": "Stereochemistry type.",
"isModifier": false,
"short": "Stereochemistry type",
"mapping": [ {
"map": "Structure.Stereochemistry",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-stereochemistry",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceStereochemistry"
} ],
"description": "The optical rotation type of a substance."
},
"max": "1",
"id": "SubstanceDefinition.structure.stereochemistry",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.stereochemistry"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.opticalActivity",
"min": 0,
"definition": "Optical activity type.",
"isModifier": false,
"short": "Optical activity type",
"mapping": [ {
"map": "Structure.Optical_Activity",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-optical-activity",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceOpticalActivity"
} ],
"description": "The optical rotation type of a substance."
},
"max": "1",
"id": "SubstanceDefinition.structure.opticalActivity",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.opticalActivity"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.molecularFormula",
"min": 0,
"definition": "An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]",
"isModifier": false,
"short": "Molecular Formula",
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"map": "Structure.Molecular_Formula",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.structure.molecularFormula",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.molecularFormula"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.molecularFormulaByMoiety",
"min": 0,
"definition": "Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.",
"isModifier": false,
"short": "Specified per moiety according to the Hill system",
"mapping": [ {
"map": "Structure.Molecular_Formula_By_Moiety",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
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"max": "1",
"id": "SubstanceDefinition.structure.molecularFormulaByMoiety",
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"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.molecularFormulaByMoiety"
},
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}, {
"constraint": [ {
"key": "ele-1",
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"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
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} ],
"path": "SubstanceDefinition.structure.molecularWeight",
"min": 0,
"definition": "The molecular weight or weight range (for proteins, polymers or nucleic acids).",
"isModifier": false,
"short": "The molecular weight or weight range",
"mapping": [ {
"map": "Structure.Molecular_Weight",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight",
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"max": "1",
"id": "SubstanceDefinition.structure.molecularWeight",
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"max": "1",
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"path": "SubstanceDefinition.structure.molecularWeight"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
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"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.technique",
"min": 0,
"definition": "The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.",
"isModifier": false,
"short": "Substance Characterisation Technique",
"mapping": [ {
"map": "n/a,CD",
"identity": "rim"
}, {
"map": "CE/CNE/CWE",
"identity": "v2"
}, {
"map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
"identity": "orim"
} ],
"type": [ {
"code": "CodeableConcept",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only" ]
} ],
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"strength": "example",
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"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceStructureTechnique"
} ],
"description": "The method used to elucidate the structure of the drug substance."
},
"max": "1",
"id": "SubstanceDefinition.structure.technique",
"comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.technique"
}
}, {
"constraint": [ {
"key": "ele-1",
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"severity": "error",
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} ],
"path": "SubstanceDefinition.structure.sourceDocument",
"min": 0,
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"isModifier": false,
"short": "Source of information for the structure",
"mapping": [ {
"map": "Structure.Reference_Source",
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} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
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"path": "SubstanceDefinition.structure.sourceDocument"
},
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}, {
"constraint": [ {
"key": "ele-1",
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} ],
"path": "SubstanceDefinition.structure.representation",
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"definition": "A depiction of the structure of the substance.",
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"short": "Impurity Structure Graphic | Impurity Structure Data File",
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"map": "Structure.Structural_Representation",
"identity": "idmp-substance"
} ],
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "SubstanceDefinition.structure.representation",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.representation"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.structure.representation.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.structure.representation.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
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"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
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"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
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"severity": "error",
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} ],
"path": "SubstanceDefinition.structure.representation.type",
"min": 1,
"definition": "The kind of structural representation (e.g. full, partial).",
"isModifier": false,
"short": "The kind of structural representation (e.g. full, partial)",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"
},
"max": "1",
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"path": "SubstanceDefinition.structure.representation.type"
},
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}, {
"constraint": [ {
"key": "ele-1",
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"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.representation",
"min": 0,
"definition": "The structural representation as a text string in a standard format.",
"isModifier": false,
"short": "The structural representation as a text string in a standard format",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation",
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} ],
"type": [ {
"code": "string"
} ],
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"max": "1",
"id": "SubstanceDefinition.structure.representation.representation",
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"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.representation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
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"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.format",
"min": 0,
"definition": "The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.",
"isModifier": false,
"short": "The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
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"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRepresentationFormat"
} ],
"description": "A format of a substance representation."
},
"max": "1",
"id": "SubstanceDefinition.structure.representation.format",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.format"
},
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}, {
"constraint": [ {
"key": "ele-1",
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"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.document",
"min": 0,
"definition": "An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.",
"isModifier": false,
"short": "An attachment with the structural representation e.g. a structure graphic or AnIML file",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Attachment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.structure.representation.document",
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"path": "SubstanceDefinition.structure.representation.document"
},
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}, {
"constraint": [ {
"key": "ele-1",
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} ],
"path": "SubstanceDefinition.structure.representation",
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"definition": "A depiction of the structure of the substance.",
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"short": "A graphical, displayable depiction of the structure (e.g. an SVG, PNG)",
"mapping": [ {
"map": "Structure.Structural_Representation",
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} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "graphic",
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"id": "SubstanceDefinition.structure.representation:graphic",
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"min": 0,
"path": "SubstanceDefinition.structure.representation"
},
"isSummary": true
}, {
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"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.structure.representation:graphic.id",
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"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
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}, {
"constraint": [ {
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}, {
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} ],
"path": "SubstanceDefinition.structure.representation.extension",
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} ],
"type": [ {
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} ],
"alias": [ "extensions", "user content" ],
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"id": "SubstanceDefinition.structure.representation:graphic.extension",
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"path": "Element.extension"
},
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}, {
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}, {
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} ],
"path": "SubstanceDefinition.structure.representation.modifierExtension",
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"type": [ {
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"base": {
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"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
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}, {
"constraint": [ {
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} ],
"path": "SubstanceDefinition.structure.representation.type",
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"isModifier": false,
"short": "Graphic",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Type",
"identity": "idmp-substance"
} ],
"type": [ {
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"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-representation-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRepresentationType"
} ],
"description": "A format of a substance representation."
},
"max": "1",
"id": "SubstanceDefinition.structure.representation:graphic.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C54273",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
},
"base": {
"max": "1",
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"path": "SubstanceDefinition.structure.representation.type"
},
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}, {
"constraint": [ {
"key": "ele-1",
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} ],
"path": "SubstanceDefinition.structure.representation.representation",
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"short": "The structural representation as a text string in a standard format",
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} ],
"type": [ {
"code": "string"
} ],
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"id": "SubstanceDefinition.structure.representation:graphic.representation",
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"path": "SubstanceDefinition.structure.representation.representation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
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} ],
"path": "SubstanceDefinition.structure.representation.format",
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"short": "The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)",
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} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
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"valueString": "SubstanceRepresentationFormat"
} ],
"description": "A format of a substance representation."
},
"max": "1",
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"path": "SubstanceDefinition.structure.representation.format"
},
"isSummary": true
}, {
"constraint": [ {
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"path": "SubstanceDefinition.structure.representation.document",
"min": 1,
"definition": "A pictorial representation of the structure of the impurity substance. \n[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for \nuse in eCTD' Example: This is the representation of the molecule CH3OH, \nor the sequence SHLVEALALVAGERG.",
"isModifier": false,
"short": "Impurity Structure Graphic",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Attachment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.structure.representation:graphic.document",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.document"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation",
"min": 0,
"definition": "A depiction of the structure of the substance.",
"isModifier": false,
"short": "machine-readable representation -- attached file",
"mapping": [ {
"map": "Structure.Structural_Representation",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "structureFile",
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureFile",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.representation"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.structure.representation.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureFile.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureFile.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureFile.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.type",
"min": 0,
"definition": "The kind of structural representation (e.g. full, partial).",
"isModifier": false,
"short": "Structure File",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-representation-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRepresentationType"
} ],
"description": "A format of a substance representation."
},
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureFile.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C103240",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
},
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.representation",
"min": 0,
"definition": "The structural representation as a text string in a standard format.",
"isModifier": false,
"short": "The structural representation as a text string in a standard format",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureFile.representation",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.representation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.format",
"min": 0,
"definition": "The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.",
"isModifier": false,
"short": "The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-representation-format",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRepresentationFormat"
} ],
"description": "A format of a substance representation."
},
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureFile.format",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.format"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.document",
"min": 1,
"definition": "An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.",
"isModifier": false,
"short": "Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Attachment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference" ]
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureFile.document",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.document"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation",
"min": 0,
"definition": "A depiction of the structure of the substance.",
"isModifier": false,
"short": "machine-readable representation -- plain text",
"mapping": [ {
"map": "Structure.Structural_Representation",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "structureString",
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureString",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.representation"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.structure.representation.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureString.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
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"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureString.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.structure.representation.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.structure.representation:structureString.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.type",
"min": 0,
"definition": "The kind of structural representation (e.g. full, partial).",
"isModifier": false,
"short": "Structure Textual",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-representation-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRepresentationType"
} ],
"description": "A format of a substance representation."
},
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureString.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C45253",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
},
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.representation",
"min": 1,
"definition": "A machine-readable representation of the structure of the chemical. [Source: SME Defined]\nExamples: SMILES, INCHI",
"isModifier": false,
"short": "Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureString.representation",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.representation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.format",
"min": 1,
"definition": "The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.",
"isModifier": false,
"short": "Drug Substance Impurity Method Type",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology"
},
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureString.format",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.format"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.structure.representation.document",
"min": 0,
"definition": "An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.",
"isModifier": false,
"short": "An attachment with the structural representation e.g. a structure graphic or AnIML file",
"mapping": [ {
"map": "Structural_Representation.Structural_Representation_Attachment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.structure.representation:structureString.document",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation.document"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code",
"min": 0,
"definition": "Codes associated with the substance.",
"isModifier": false,
"short": "Codes associated with the substance",
"mapping": [ {
"map": "Substance.Substance_Code",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.code",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.code"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.code.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.code.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code",
"min": 0,
"definition": "The specific code.",
"isModifier": false,
"short": "The specific code",
"mapping": [ {
"map": "Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.code.code",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.code.code"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.code.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.code.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.code.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.code.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/",
"isModifier": false,
"short": "UNII",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "SubstanceDefinition.code.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.code.code.coding.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.code.code.coding.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.code.code.coding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding.system",
"requirements": "Need to be unambiguous about the source of the definition of the symbol.",
"min": 0,
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"isModifier": false,
"short": "Identity of the terminology system",
"mapping": [ {
"map": "C*E.3",
"identity": "v2"
}, {
"map": "./codeSystem",
"identity": "rim"
}, {
"map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
"identity": "orim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.system",
"comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.system"
},
"patternUri": "http://fdasis.nlm.nih.gov",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding.version",
"min": 0,
"definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"isModifier": false,
"short": "Version of the system - if relevant",
"mapping": [ {
"map": "C*E.7",
"identity": "v2"
}, {
"map": "./codeSystemVersion",
"identity": "rim"
}, {
"map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.version",
"comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding.code",
"requirements": "Need to refer to a particular code in the system.",
"min": 0,
"definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"isModifier": false,
"short": "Symbol in syntax defined by the system",
"mapping": [ {
"map": "C*E.1",
"identity": "v2"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
"identity": "orim"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.code",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding.display",
"requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min": 0,
"definition": "A representation of the meaning of the code in the system, following the rules of the system.",
"isModifier": false,
"short": "Representation defined by the system",
"mapping": [ {
"map": "C*E.2 - but note this is not well followed",
"identity": "v2"
}, {
"map": "CV.displayName",
"identity": "rim"
}, {
"map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.display",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.display"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.coding.userSelected",
"requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min": 0,
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"isModifier": false,
"short": "If this coding was chosen directly by the user",
"mapping": [ {
"map": "Sometimes implied by being first",
"identity": "v2"
}, {
"map": "CD.codingRationale",
"identity": "rim"
}, {
"map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]",
"identity": "orim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.coding.userSelected",
"comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.userSelected"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "SubstanceDefinition.code.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.status",
"min": 0,
"definition": "Status of the code assignment, for example 'provisional', 'approved'.",
"isModifier": false,
"short": "Status of the code assignment, for example 'provisional', 'approved'",
"mapping": [ {
"map": "Substance_Code.Code_System_Status",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.code.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.code.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.statusDate",
"min": 0,
"definition": "The date at which the code status was changed as part of the terminology maintenance.",
"isModifier": false,
"short": "The date at which the code status was changed",
"mapping": [ {
"map": "Substance_Code.Code_Change_Date",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.code.statusDate",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.code.statusDate"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.note",
"min": 0,
"definition": "Any comment can be provided in this field, if necessary.",
"isModifier": false,
"short": "Any comment can be provided in this field",
"mapping": [ {
"map": "Substance_Code.Comment",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Annotation"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.code.note",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.code.note"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.code.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Code.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.code.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.code.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "cmc-name-preferred",
"human": "Name.preferred: at most one = true",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form",
"severity": "error",
"expression": "select(preferred = true).count() < 2"
} ],
"path": "SubstanceDefinition.name",
"min": 1,
"definition": "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
"isModifier": false,
"short": "Substance Name",
"mapping": [ {
"map": "Substance.Substance_Name",
"identity": "idmp-substance"
} ],
"slicing": {
"rules": "closed",
"description": "Slice based on value pattern",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "SubstanceDefinition.name",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.name",
"min": 1,
"definition": "The actual name.",
"isModifier": false,
"short": "The actual name",
"mapping": [ {
"map": "Substance_Name.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.name.name",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.name.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.type",
"min": 0,
"definition": "Name type, for example 'systematic', 'scientific, 'brand'.",
"isModifier": false,
"short": "Name type e.g. 'systematic', 'scientific, 'brand'",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"
},
"max": "1",
"id": "SubstanceDefinition.name.type",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.status",
"min": 0,
"definition": "The status of the name, for example 'current', 'proposed'.",
"isModifier": false,
"short": "The status of the name e.g. 'current', 'proposed'",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.preferred",
"min": 0,
"definition": "If this is the preferred name for this substance.",
"isModifier": false,
"short": "True when the name type is Substance Name",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
"max": "1",
"id": "SubstanceDefinition.name.preferred",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.preferred"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.language",
"min": 0,
"definition": "Human language that the name is written in.",
"isModifier": false,
"short": "Human language that the name is written in",
"mapping": [ {
"map": "Substance_Name.Language",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "*",
"id": "SubstanceDefinition.name.language",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.language"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.domain",
"min": 0,
"definition": "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
"isModifier": false,
"short": "The use context of this name e.g. as an active ingredient or as a food colour additive",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Domain",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-domain",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameDomain"
} ],
"description": "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."
},
"max": "*",
"id": "SubstanceDefinition.name.domain",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.domain"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.jurisdiction",
"min": 0,
"definition": "The jurisdiction where this name applies.",
"isModifier": false,
"short": "The jurisdiction where this name applies",
"mapping": [ {
"map": "Substance_Name.Jurisdiction",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
} ],
"description": "Jurisdiction codes"
},
"max": "*",
"id": "SubstanceDefinition.name.jurisdiction",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.jurisdiction"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.synonym",
"min": 0,
"definition": "A synonym of this particular name, by which the substance is also known.",
"isModifier": false,
"short": "A synonym of this particular name, by which the substance is also known",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name.synonym",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.synonym"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.translation",
"min": 0,
"definition": "A translation for this name into another human language.",
"isModifier": false,
"short": "A translation for this name into another human language",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name.translation",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.translation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official",
"min": 0,
"definition": "Details of the official nature of this name.",
"isModifier": false,
"short": "Details of the official nature of this name",
"mapping": [ {
"map": "Substance_Name.Official_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name.official",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.official"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.official.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name.official.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name.official.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name.official.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.authority",
"min": 0,
"definition": "Which authority uses this official name.",
"isModifier": false,
"short": "Which authority uses this official name",
"mapping": [ {
"map": "Official_Name.Official_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-authority",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameAuthority"
} ],
"description": "An authority that officates substance names."
},
"max": "1",
"id": "SubstanceDefinition.name.official.authority",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.authority"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.status",
"min": 0,
"definition": "The status of the official name, for example 'draft', 'active', 'retired'.",
"isModifier": false,
"short": "The status of the official name, for example 'draft', 'active'",
"mapping": [ {
"map": "Official_Name.Official_Name_Status",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name.official.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.date",
"min": 0,
"definition": "Date of the official name change.",
"isModifier": false,
"short": "Date of official name change",
"mapping": [ {
"map": "Official_Name.Official_Name_Status_Change_Date",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.name.official.date",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.date"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Name.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name",
"min": 0,
"definition": "Names applicable to this substance.",
"isModifier": false,
"short": "Names applicable to this substance",
"mapping": [ {
"map": "Substance.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sub",
"max": "1",
"id": "SubstanceDefinition.name:sub",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:sub.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:sub.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:sub.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.name",
"min": 1,
"definition": "A non-branded nor registered name that meant for common use.",
"isModifier": false,
"short": "Generic Name",
"mapping": [ {
"map": "Substance_Name.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.name:sub.name",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.name.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.type",
"min": 1,
"definition": "Name type, for example 'systematic', 'scientific, 'brand'.",
"isModifier": false,
"short": "Name type e.g. 'systematic', 'scientific, 'brand'",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameType"
} ],
"description": "The type of a name given to a substance."
},
"max": "1",
"id": "SubstanceDefinition.name:sub.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C97054",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "Generic Name"
} ]
},
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.status",
"min": 0,
"definition": "The status of the name, for example 'current', 'proposed'.",
"isModifier": false,
"short": "The status of the name e.g. 'current', 'proposed'",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:sub.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.preferred",
"min": 0,
"definition": "If this is the preferred name for this substance.",
"isModifier": false,
"short": "If this is the preferred name for this substance",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
"max": "1",
"id": "SubstanceDefinition.name:sub.preferred",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.preferred"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.language",
"min": 0,
"definition": "Human language that the name is written in.",
"isModifier": false,
"short": "Human language that the name is written in",
"mapping": [ {
"map": "Substance_Name.Language",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "*",
"id": "SubstanceDefinition.name:sub.language",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.language"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.domain",
"min": 0,
"definition": "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
"isModifier": false,
"short": "The use context of this name e.g. as an active ingredient or as a food colour additive",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Domain",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-domain",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameDomain"
} ],
"description": "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."
},
"max": "*",
"id": "SubstanceDefinition.name:sub.domain",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.domain"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.jurisdiction",
"min": 0,
"definition": "The jurisdiction where this name applies.",
"isModifier": false,
"short": "The jurisdiction where this name applies",
"mapping": [ {
"map": "Substance_Name.Jurisdiction",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
} ],
"description": "Jurisdiction codes"
},
"max": "*",
"id": "SubstanceDefinition.name:sub.jurisdiction",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.jurisdiction"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.synonym",
"min": 0,
"definition": "A synonym of this particular name, by which the substance is also known.",
"isModifier": false,
"short": "A synonym of this particular name, by which the substance is also known",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:sub.synonym",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.synonym"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.translation",
"min": 0,
"definition": "A translation for this name into another human language.",
"isModifier": false,
"short": "A translation for this name into another human language",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:sub.translation",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.translation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official",
"min": 0,
"definition": "Details of the official nature of this name.",
"isModifier": false,
"short": "Details of the official nature of this name",
"mapping": [ {
"map": "Substance_Name.Official_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:sub.official",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.official"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.official.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:sub.official.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:sub.official.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:sub.official.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.authority",
"min": 0,
"definition": "Which authority uses this official name.",
"isModifier": false,
"short": "Which authority uses this official name",
"mapping": [ {
"map": "Official_Name.Official_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-authority",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameAuthority"
} ],
"description": "An authority that officates substance names."
},
"max": "1",
"id": "SubstanceDefinition.name:sub.official.authority",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.authority"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.status",
"min": 0,
"definition": "The status of the official name, for example 'draft', 'active', 'retired'.",
"isModifier": false,
"short": "The status of the official name, for example 'draft', 'active'",
"mapping": [ {
"map": "Official_Name.Official_Name_Status",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:sub.official.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.date",
"min": 0,
"definition": "Date of the official name change.",
"isModifier": false,
"short": "Date of official name change",
"mapping": [ {
"map": "Official_Name.Official_Name_Status_Change_Date",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.name:sub.official.date",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.date"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Name.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:sub.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name",
"min": 0,
"definition": "Names applicable to this substance.",
"isModifier": false,
"short": "Names applicable to this substance",
"mapping": [ {
"map": "Substance.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "gsrs",
"max": "1",
"id": "SubstanceDefinition.name:gsrs",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:gsrs.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:gsrs.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:gsrs.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.name",
"min": 1,
"definition": "Default display name identified within FDA Global Substance Registration System (GSRS).",
"isModifier": false,
"short": "GSRS Preferred Term",
"mapping": [ {
"map": "Substance_Name.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.name:gsrs.name",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.name.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.type",
"min": 1,
"definition": "Name type, for example 'systematic', 'scientific, 'brand'.",
"isModifier": false,
"short": "Name type e.g. 'systematic', 'scientific, 'brand'",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameType"
} ],
"description": "The type of a name given to a substance."
},
"max": "1",
"id": "SubstanceDefinition.name:gsrs.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C203355",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "GSRS Preferred Term"
} ]
},
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.status",
"min": 0,
"definition": "The status of the name, for example 'current', 'proposed'.",
"isModifier": false,
"short": "The status of the name e.g. 'current', 'proposed'",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:gsrs.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.preferred",
"min": 0,
"definition": "If this is the preferred name for this substance.",
"isModifier": false,
"short": "If this is the preferred name for this substance",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
"max": "1",
"id": "SubstanceDefinition.name:gsrs.preferred",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.preferred"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.language",
"min": 0,
"definition": "Human language that the name is written in.",
"isModifier": false,
"short": "Human language that the name is written in",
"mapping": [ {
"map": "Substance_Name.Language",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "*",
"id": "SubstanceDefinition.name:gsrs.language",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.language"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.domain",
"min": 0,
"definition": "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
"isModifier": false,
"short": "The use context of this name e.g. as an active ingredient or as a food colour additive",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Domain",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-domain",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameDomain"
} ],
"description": "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."
},
"max": "*",
"id": "SubstanceDefinition.name:gsrs.domain",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.domain"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.jurisdiction",
"min": 0,
"definition": "The jurisdiction where this name applies.",
"isModifier": false,
"short": "The jurisdiction where this name applies",
"mapping": [ {
"map": "Substance_Name.Jurisdiction",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
} ],
"description": "Jurisdiction codes"
},
"max": "*",
"id": "SubstanceDefinition.name:gsrs.jurisdiction",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.jurisdiction"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.synonym",
"min": 0,
"definition": "A synonym of this particular name, by which the substance is also known.",
"isModifier": false,
"short": "A synonym of this particular name, by which the substance is also known",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:gsrs.synonym",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.synonym"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.translation",
"min": 0,
"definition": "A translation for this name into another human language.",
"isModifier": false,
"short": "A translation for this name into another human language",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:gsrs.translation",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.translation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official",
"min": 0,
"definition": "Details of the official nature of this name.",
"isModifier": false,
"short": "Details of the official nature of this name",
"mapping": [ {
"map": "Substance_Name.Official_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:gsrs.official",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.official"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.official.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:gsrs.official.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:gsrs.official.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:gsrs.official.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.authority",
"min": 0,
"definition": "Which authority uses this official name.",
"isModifier": false,
"short": "Which authority uses this official name",
"mapping": [ {
"map": "Official_Name.Official_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-authority",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameAuthority"
} ],
"description": "An authority that officates substance names."
},
"max": "1",
"id": "SubstanceDefinition.name:gsrs.official.authority",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.authority"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.status",
"min": 0,
"definition": "The status of the official name, for example 'draft', 'active', 'retired'.",
"isModifier": false,
"short": "The status of the official name, for example 'draft', 'active'",
"mapping": [ {
"map": "Official_Name.Official_Name_Status",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:gsrs.official.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.date",
"min": 0,
"definition": "Date of the official name change.",
"isModifier": false,
"short": "Date of official name change",
"mapping": [ {
"map": "Official_Name.Official_Name_Status_Change_Date",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.name:gsrs.official.date",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.date"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Name.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:gsrs.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name",
"min": 0,
"definition": "Names applicable to this substance.",
"isModifier": false,
"short": "Names applicable to this substance",
"mapping": [ {
"map": "Substance.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "isbt",
"max": "1",
"id": "SubstanceDefinition.name:isbt",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:isbt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:isbt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:isbt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.name",
"min": 1,
"definition": "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
"isModifier": false,
"short": "ISBT-128 DIN",
"mapping": [ {
"map": "Substance_Name.Substance_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "SubstanceDefinition.name:isbt.name",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.name.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.type",
"min": 1,
"definition": "Name type, for example 'systematic', 'scientific, 'brand'.",
"isModifier": false,
"short": "Name type e.g. 'systematic', 'scientific, 'brand'",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameType"
} ],
"description": "The type of a name given to a substance."
},
"max": "1",
"id": "SubstanceDefinition.name:isbt.type",
"patternCodeableConcept": {
"coding": [ {
"code": "C95517",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "ISBT-128 DIN"
} ]
},
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.status",
"min": 0,
"definition": "The status of the name, for example 'current', 'proposed'.",
"isModifier": false,
"short": "The status of the name e.g. 'current', 'proposed'",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:isbt.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.preferred",
"min": 0,
"definition": "If this is the preferred name for this substance.",
"isModifier": false,
"short": "If this is the preferred name for this substance",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": true,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
"max": "1",
"id": "SubstanceDefinition.name:isbt.preferred",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.preferred"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.language",
"min": 0,
"definition": "Human language that the name is written in.",
"isModifier": false,
"short": "Human language that the name is written in",
"mapping": [ {
"map": "Substance_Name.Language",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "*",
"id": "SubstanceDefinition.name:isbt.language",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.language"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.domain",
"min": 0,
"definition": "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
"isModifier": false,
"short": "The use context of this name e.g. as an active ingredient or as a food colour additive",
"mapping": [ {
"map": "Substance_Name.Substance_Name_Domain",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-domain",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameDomain"
} ],
"description": "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."
},
"max": "*",
"id": "SubstanceDefinition.name:isbt.domain",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.domain"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.jurisdiction",
"min": 0,
"definition": "The jurisdiction where this name applies.",
"isModifier": false,
"short": "The jurisdiction where this name applies",
"mapping": [ {
"map": "Substance_Name.Jurisdiction",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
} ],
"description": "Jurisdiction codes"
},
"max": "*",
"id": "SubstanceDefinition.name:isbt.jurisdiction",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.jurisdiction"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.synonym",
"min": 0,
"definition": "A synonym of this particular name, by which the substance is also known.",
"isModifier": false,
"short": "A synonym of this particular name, by which the substance is also known",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:isbt.synonym",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.synonym"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.translation",
"min": 0,
"definition": "A translation for this name into another human language.",
"isModifier": false,
"short": "A translation for this name into another human language",
"mapping": [ {
"map": "n/a",
"identity": "idmp-substance"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:isbt.translation",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.translation"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official",
"min": 0,
"definition": "Details of the official nature of this name.",
"isModifier": false,
"short": "Details of the official nature of this name",
"mapping": [ {
"map": "Substance_Name.Official_Name",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:isbt.official",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.official"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.name.official.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.name:isbt.official.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.name:isbt.official.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.name.official.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.name:isbt.official.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.authority",
"min": 0,
"definition": "Which authority uses this official name.",
"isModifier": false,
"short": "Which authority uses this official name",
"mapping": [ {
"map": "Official_Name.Official_Name_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-name-authority",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceNameAuthority"
} ],
"description": "An authority that officates substance names."
},
"max": "1",
"id": "SubstanceDefinition.name:isbt.official.authority",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.authority"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.status",
"min": 0,
"definition": "The status of the official name, for example 'draft', 'active', 'retired'.",
"isModifier": false,
"short": "The status of the official name, for example 'draft', 'active'",
"mapping": [ {
"map": "Official_Name.Official_Name_Status",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
} ],
"description": "The lifecycle status of an artifact."
},
"max": "1",
"id": "SubstanceDefinition.name:isbt.official.status",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.status"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.official.date",
"min": 0,
"definition": "Date of the official name change.",
"isModifier": false,
"short": "Date of official name change",
"mapping": [ {
"map": "Official_Name.Official_Name_Status_Change_Date",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.name:isbt.official.date",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name.official.date"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.name.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Name.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.name:isbt.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.name.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship",
"min": 0,
"definition": "A link between this substance and another, with details of the relationship.",
"isModifier": false,
"short": "A link between this substance and another",
"mapping": [ {
"map": "Substance.Reference_Information.Relationship",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.relationship",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.relationship"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.relationship.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.relationship.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.relationship.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.relationship.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.relationship.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.relationship.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.substanceDefinition[x]",
"min": 0,
"definition": "A pointer to another substance, as a resource or just a representational code.",
"isModifier": false,
"short": "A pointer to another substance, as a resource or a representational code",
"mapping": [ {
"map": "Substance_Relationship.Related_Substance_Id",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition" ]
}, {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.relationship.substanceDefinition[x]",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.relationship.substanceDefinition[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.type",
"min": 1,
"definition": "For example \"salt to parent\", \"active moiety\", \"starting material\", \"polymorph\", \"impurity of\".",
"isModifier": false,
"short": "For example \"salt to parent\", \"active moiety\"",
"mapping": [ {
"map": "Substance_Relationship.Relationship_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-relationship-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceRelationshipType"
} ],
"description": "The relationship between two substance types."
},
"max": "1",
"id": "SubstanceDefinition.relationship.type",
"base": {
"max": "1",
"min": 1,
"path": "SubstanceDefinition.relationship.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.isDefining",
"min": 0,
"definition": "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.",
"isModifier": false,
"short": "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships",
"mapping": [ {
"map": "Substance_Relationship.Is_Defining",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made",
"max": "1",
"id": "SubstanceDefinition.relationship.isDefining",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.relationship.isDefining"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.amount[x]",
"min": 0,
"definition": "A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.",
"isModifier": false,
"short": "A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other",
"mapping": [ {
"map": "Substance_Relationship.Amount.Quantity",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Quantity"
}, {
"code": "Ratio"
}, {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.relationship.amount[x]",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.relationship.amount[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.ratioHighLimitAmount",
"min": 0,
"definition": "For use when the numeric has an uncertain range.",
"isModifier": false,
"short": "For use when the numeric has an uncertain range",
"mapping": [ {
"map": "Substance_Relationship.Amount.Quantity.High_Limit",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Ratio"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.relationship.ratioHighLimitAmount",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.relationship.ratioHighLimitAmount"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.comparator",
"min": 0,
"definition": "An operator for the amount, for example \"average\", \"approximately\", \"less than\".",
"isModifier": false,
"short": "An operator for the amount, for example \"average\", \"approximately\", \"less than\"",
"mapping": [ {
"map": "Substance_Relationship.Amount_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-amount-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceAmountType"
} ],
"description": "The relationship between two substance types."
},
"max": "1",
"id": "SubstanceDefinition.relationship.comparator",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.relationship.comparator"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.relationship.source",
"min": 0,
"definition": "Supporting literature.",
"isModifier": false,
"short": "Supporting literature",
"mapping": [ {
"map": "Substance_Relationship.Reference_Source",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ]
} ],
"mustSupport": false,
"max": "*",
"id": "SubstanceDefinition.relationship.source",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.relationship.source"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.nucleicAcid",
"min": 0,
"definition": "Data items specific to nucleic acids.",
"isModifier": false,
"short": "Data items specific to nucleic acids",
"mapping": [ {
"map": "(used to add specifics of Nucleic Acids to Substances)",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceNucleicAcid" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.nucleicAcid",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.nucleicAcid"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.polymer",
"min": 0,
"definition": "Data items specific to polymers.",
"isModifier": false,
"short": "Data items specific to polymers",
"mapping": [ {
"map": "(used to add specifics of Polymers to Substances)",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstancePolymer" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.polymer",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.polymer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.protein",
"min": 0,
"definition": "Data items specific to proteins.",
"isModifier": false,
"short": "Data items specific to proteins",
"mapping": [ {
"map": "(used to add specifics of Proteins to Substances)",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceProtein" ]
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.protein",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.protein"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial",
"min": 0,
"definition": "Material or taxonomic/anatomical source for the substance.",
"isModifier": false,
"short": "Material or taxonomic/anatomical source",
"mapping": [ {
"map": "Substance.Source_Material",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "1",
"id": "SubstanceDefinition.sourceMaterial",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial"
},
"isSummary": true
}, {
"path": "SubstanceDefinition.sourceMaterial.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "SubstanceDefinition.sourceMaterial.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.sourceMaterial.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "SubstanceDefinition.sourceMaterial.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "SubstanceDefinition.sourceMaterial.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "SubstanceDefinition.sourceMaterial.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial.type",
"min": 0,
"definition": "A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.",
"isModifier": false,
"short": "Classification of the origin of the raw material. e.g. cat hair is an Animal source type",
"mapping": [ {
"map": "Source_Material.Source_Material_Type",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-source-material-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SourceMaterialType"
} ],
"description": "A classification that provides the origin of the substance raw material."
},
"max": "1",
"id": "SubstanceDefinition.sourceMaterial.type",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial.genus",
"min": 0,
"definition": "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.",
"isModifier": false,
"short": "The genus of an organism e.g. the Latin epithet of the plant/animal scientific name",
"mapping": [ {
"map": "Source_Material.Organism.Genus",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-source-material-genus",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SourceMaterialGenus"
} ],
"description": "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name."
},
"max": "1",
"id": "SubstanceDefinition.sourceMaterial.genus",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial.genus"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial.species",
"min": 0,
"definition": "The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.",
"isModifier": false,
"short": "The species of an organism e.g. the Latin epithet of the species of the plant/animal",
"mapping": [ {
"map": "Source_Material.Organism.Species",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-source-material-species",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SourceMaterialSpecies"
} ],
"description": "A species of origin a substance raw material."
},
"max": "1",
"id": "SubstanceDefinition.sourceMaterial.species",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial.species"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial.part",
"min": 0,
"definition": "An anatomical origin of the source material within an organism.",
"isModifier": false,
"short": "An anatomical origin of the source material within an organism",
"mapping": [ {
"map": "Source_Material.Part_Description.Part",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-source-material-part",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SourceMaterialPart"
} ],
"description": "An anatomical origin of the source material within an organism."
},
"max": "1",
"id": "SubstanceDefinition.sourceMaterial.part",
"base": {
"max": "1",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial.part"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "SubstanceDefinition.sourceMaterial.countryOfOrigin",
"min": 0,
"definition": "The country or countries where the material is harvested.",
"isModifier": false,
"short": "The country or countries where the material is harvested",
"mapping": [ {
"map": "Source_Material.Country_Of_Origin",
"identity": "idmp-substance"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/country|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Country"
} ],
"description": "Jurisdiction codes"
},
"max": "*",
"id": "SubstanceDefinition.sourceMaterial.countryOfOrigin",
"base": {
"max": "*",
"min": 0,
"path": "SubstanceDefinition.sourceMaterial.countryOfOrigin"
},
"isSummary": true
} ]
},
"status": "active",
"id": "424f4c4e-3652-4b80-b2a1-228ca646980b",
"kind": "resource",
"url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.28",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0",
"differential": {
"element": [ {
"id": "SubstanceDefinition.identifier",
"max": "1",
"path": "SubstanceDefinition.identifier",
"short": "optional user designated identifier",
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure",
"path": "SubstanceDefinition.structure",
"constraint": [ {
"key": "cmc-structure-representation-required",
"human": "Either a file or string structure representation is required",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form",
"severity": "error",
"expression": "representation.type.coding.where(\n system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'\n and (code in ('C45253' | 'C103240'))\n).exists()"
} ],
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.molecularFormula",
"path": "SubstanceDefinition.structure.molecularFormula",
"short": "Molecular Formula",
"definition": "An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]",
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.technique",
"max": "1",
"path": "SubstanceDefinition.structure.technique",
"type": [ {
"code": "CodeableConcept",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only" ]
} ],
"short": "Substance Characterisation Technique",
"definition": "The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.",
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.representation",
"path": "SubstanceDefinition.structure.representation",
"short": "Impurity Structure Graphic | Impurity Structure Data File",
"slicing": {
"rules": "closed",
"ordered": false,
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.representation.type",
"min": 1,
"path": "SubstanceDefinition.structure.representation.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"
},
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.representation:graphic",
"max": "1",
"min": 0,
"path": "SubstanceDefinition.structure.representation",
"short": "A graphical, displayable depiction of the structure (e.g. an SVG, PNG)",
"sliceName": "graphic"
}, {
"id": "SubstanceDefinition.structure.representation:graphic.type",
"path": "SubstanceDefinition.structure.representation.type",
"short": "Graphic",
"patternCodeableConcept": {
"coding": [ {
"code": "C54273",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
}
}, {
"id": "SubstanceDefinition.structure.representation:graphic.document",
"min": 1,
"path": "SubstanceDefinition.structure.representation.document",
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference" ]
} ],
"short": "Impurity Structure Graphic",
"definition": "A pictorial representation of the structure of the impurity substance. \n[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for \nuse in eCTD' Example: This is the representation of the molecule CH3OH, \nor the sequence SHLVEALALVAGERG."
}, {
"id": "SubstanceDefinition.structure.representation:structureFile",
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.representation",
"short": "machine-readable representation -- attached file",
"sliceName": "structureFile"
}, {
"id": "SubstanceDefinition.structure.representation:structureFile.type",
"path": "SubstanceDefinition.structure.representation.type",
"short": "Structure File",
"patternCodeableConcept": {
"coding": [ {
"code": "C103240",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
}
}, {
"id": "SubstanceDefinition.structure.representation:structureFile.document",
"min": 1,
"path": "SubstanceDefinition.structure.representation.document",
"type": [ {
"code": "Reference",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference" ],
"aggregation": [ "bundled" ],
"targetProfile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference" ]
} ],
"short": "Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)",
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.representation:structureString",
"max": "*",
"min": 0,
"path": "SubstanceDefinition.structure.representation",
"short": "machine-readable representation -- plain text",
"sliceName": "structureString"
}, {
"id": "SubstanceDefinition.structure.representation:structureString.type",
"path": "SubstanceDefinition.structure.representation.type",
"short": "Structure Textual",
"patternCodeableConcept": {
"coding": [ {
"code": "C45253",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
}
}, {
"id": "SubstanceDefinition.structure.representation:structureString.representation",
"min": 1,
"path": "SubstanceDefinition.structure.representation.representation",
"short": "Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)",
"definition": "A machine-readable representation of the structure of the chemical. [Source: SME Defined]\nExamples: SMILES, INCHI",
"mustSupport": true
}, {
"id": "SubstanceDefinition.structure.representation:structureString.format",
"min": 1,
"path": "SubstanceDefinition.structure.representation.format",
"short": "Drug Substance Impurity Method Type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology"
},
"mustSupport": true
}, {
"id": "SubstanceDefinition.code",
"max": "1",
"path": "SubstanceDefinition.code",
"mustSupport": true
}, {
"id": "SubstanceDefinition.code.code.coding",
"path": "SubstanceDefinition.code.code.coding",
"short": "UNII",
"definition": "The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/"
}, {
"id": "SubstanceDefinition.code.code.coding.system",
"path": "SubstanceDefinition.code.code.coding.system",
"patternUri": "http://fdasis.nlm.nih.gov"
}, {
"id": "SubstanceDefinition.name",
"min": 1,
"path": "SubstanceDefinition.name",
"short": "Substance Name",
"slicing": {
"rules": "closed",
"description": "Slice based on value pattern",
"discriminator": [ {
"path": "type",
"type": "value"
} ]
},
"constraint": [ {
"key": "cmc-name-preferred",
"human": "Name.preferred: at most one = true",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form",
"severity": "error",
"expression": "select(preferred = true).count() < 2"
} ],
"definition": "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name.type",
"path": "SubstanceDefinition.name.type",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"
}
}, {
"id": "SubstanceDefinition.name.preferred",
"path": "SubstanceDefinition.name.preferred",
"short": "True when the name type is Substance Name",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:sub",
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name",
"sliceName": "sub",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:sub.name",
"path": "SubstanceDefinition.name.name",
"short": "Generic Name",
"definition": "A non-branded nor registered name that meant for common use.",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:sub.type",
"min": 1,
"path": "SubstanceDefinition.name.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "C97054",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "Generic Name"
} ]
}
}, {
"id": "SubstanceDefinition.name:sub.preferred",
"path": "SubstanceDefinition.name.preferred",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:gsrs",
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name",
"sliceName": "gsrs",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:gsrs.name",
"path": "SubstanceDefinition.name.name",
"short": "GSRS Preferred Term",
"definition": "Default display name identified within FDA Global Substance Registration System (GSRS).",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:gsrs.type",
"min": 1,
"path": "SubstanceDefinition.name.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "C203355",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "GSRS Preferred Term"
} ]
}
}, {
"id": "SubstanceDefinition.name:gsrs.preferred",
"path": "SubstanceDefinition.name.preferred",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:isbt",
"max": "1",
"min": 0,
"path": "SubstanceDefinition.name",
"sliceName": "isbt",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:isbt.name",
"path": "SubstanceDefinition.name.name",
"short": "ISBT-128 DIN",
"definition": "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
"mustSupport": true
}, {
"id": "SubstanceDefinition.name:isbt.type",
"min": 1,
"path": "SubstanceDefinition.name.type",
"mustSupport": true,
"patternCodeableConcept": {
"coding": [ {
"code": "C95517",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"display": "ISBT-128 DIN"
} ]
}
}, {
"id": "SubstanceDefinition.name:isbt.preferred",
"path": "SubstanceDefinition.name.preferred",
"mustSupport": true
} ]
},
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "brr@lists.HL7.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"
}