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8.20 Resource SubstanceReferenceInformation - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

Todo.

8.20.1 Scope and Usage

Any pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions.

A Medicinal Product may contain in the packaging one or more manufactured items and one or more pharmaceutical products. In certain regions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.

This applies to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorised by a Medicines Regulatory Agency. However, the provisions do not apply to: i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), iii) medicinal products intended for research and development trials (see 11.2 Investigational Medicinal Product) and to iv) intermediate products intended for subsequent processing by an authorised manufacturer. [from ENV 13607 and ENV 12610]

This resource is referenced by substancespecification

Structure

Name	Flags	Card.	Type	Description & Constraints
SubstanceReferenceInformation	Σ D		DomainResource	Todo Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
comment	Σ	0..1	string	Todo
gene	Σ	0..*	BackboneElement	Todo
geneSequenceOrigin	Σ	0..1	CodeableConcept	Todo
gene	Σ	0..1	CodeableConcept	Todo
source	Σ	0..*	Reference(DocumentReference)	Todo
geneElement	Σ	0..*	BackboneElement	Todo
type	Σ	0..1	CodeableConcept	Todo
element	Σ	0..1	Identifier	Todo
source	Σ	0..*	Reference(DocumentReference)	Todo
classification	Σ	0..*	BackboneElement	Todo
domain	Σ	0..1	CodeableConcept	Todo
classification	Σ	0..1	CodeableConcept	Todo
subtype	Σ	0..*	CodeableConcept	Todo
source	Σ	0..*	Reference(DocumentReference)	Todo
relationship	Σ	0..*	BackboneElement	Todo
substance[x]	Σ	0..1		Todo
substanceReference			Reference(SubstanceSpecification)
substanceCodeableConcept			CodeableConcept
relationship	Σ	0..1	CodeableConcept	Todo
interaction	Σ	0..1	CodeableConcept	Todo
isDefining	Σ	0..1	boolean	Todo
amount[x]	Σ	0..1		Todo
amountQuantity			Quantity
amountRange			Range
amountString			string
amountType	Σ	0..1	CodeableConcept	Todo
amountText	Σ	0..1	string	Todo
source	Σ	0..*	Reference(DocumentReference)	Todo
target	Σ	0..*	BackboneElement	Todo
target	Σ	0..1	Identifier	Todo
type	Σ	0..1	CodeableConcept	Todo
interaction	Σ	0..1	CodeableConcept	Todo
organism	Σ	0..1	CodeableConcept	Todo
organismType	Σ	0..1	CodeableConcept	Todo
source	Σ	0..*	Reference(DocumentReference)	Todo
amount[x]	Σ	0..1		Todo
amountQuantity			Quantity
amountRange			Range
amountString			string
amountType	Σ	0..1	CodeableConcept	Todo
Documentation for this format

UML Diagram (Legend)

XML Template

<SubstanceReferenceInformation xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <comment value="[string]"/><!-- 0..1 Todo -->
 <gene>  <!-- 0..* Todo -->
  <geneSequenceOrigin><!-- 0..1 CodeableConcept Todo --></geneSequenceOrigin>
  <gene><!-- 0..1 CodeableConcept Todo --></gene>
  <source><!-- 0..* Reference(DocumentReference) Todo --></source>
 </gene>
 <geneElement>  <!-- 0..* Todo -->
  <type><!-- 0..1 CodeableConcept Todo --></type>
  <element><!-- 0..1 Identifier Todo --></element>
  <source><!-- 0..* Reference(DocumentReference) Todo --></source>
 </geneElement>
 <classification>  <!-- 0..* Todo -->
  <domain><!-- 0..1 CodeableConcept Todo --></domain>
  <classification><!-- 0..1 CodeableConcept Todo --></classification>
  <subtype><!-- 0..* CodeableConcept Todo --></subtype>
  <source><!-- 0..* Reference(DocumentReference) Todo --></source>
 </classification>
 <relationship>  <!-- 0..* Todo -->
  <substance[x]><!-- 0..1 Reference(SubstanceSpecification)|CodeableConcept Todo --></substance[x]>
  <relationship><!-- 0..1 CodeableConcept Todo --></relationship>
  <interaction><!-- 0..1 CodeableConcept Todo --></interaction>
  <isDefining value="[boolean]"/><!-- 0..1 Todo -->
  <amount[x]><!-- 0..1 Quantity|Range|string Todo --></amount[x]>
  <amountType><!-- 0..1 CodeableConcept Todo --></amountType>
  <amountText value="[string]"/><!-- 0..1 Todo -->
  <source><!-- 0..* Reference(DocumentReference) Todo --></source>
 </relationship>
 <target>  <!-- 0..* Todo -->
  <target><!-- 0..1 Identifier Todo --></target>
  <type><!-- 0..1 CodeableConcept Todo --></type>
  <interaction><!-- 0..1 CodeableConcept Todo --></interaction>
  <organism><!-- 0..1 CodeableConcept Todo --></organism>
  <organismType><!-- 0..1 CodeableConcept Todo --></organismType>
  <source><!-- 0..* Reference(DocumentReference) Todo --></source>
  <amount[x]><!-- 0..1 Quantity|Range|string Todo --></amount[x]>
  <amountType><!-- 0..1 CodeableConcept Todo --></amountType>
 </target>
</SubstanceReferenceInformation>

JSON Template

{
  "resourceType" : "SubstanceReferenceInformation",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "comment" : "<string>", // Todo
  "gene" : [{ // Todo
    "geneSequenceOrigin" : { CodeableConcept }, // Todo
    "gene" : { CodeableConcept }, // Todo
    "source" : [{ Reference(DocumentReference) }] // Todo
  }],
  "geneElement" : [{ // Todo
    "type" : { CodeableConcept }, // Todo
    "element" : { Identifier }, // Todo
    "source" : [{ Reference(DocumentReference) }] // Todo
  }],
  "classification" : [{ // Todo
    "domain" : { CodeableConcept }, // Todo
    "classification" : { CodeableConcept }, // Todo
    "subtype" : [{ CodeableConcept }], // Todo
    "source" : [{ Reference(DocumentReference) }] // Todo
  }],
  "relationship" : [{ // Todo
    // substance[x]: Todo. One of these 2:
    "substanceReference" : { Reference(SubstanceSpecification) },
    "substanceCodeableConcept" : { CodeableConcept },
    "relationship" : { CodeableConcept }, // Todo
    "interaction" : { CodeableConcept }, // Todo
    "isDefining" : <boolean>, // Todo
    // amount[x]: Todo. One of these 3:
    "amountQuantity" : { Quantity },
    "amountRange" : { Range },
    "amountString" : "<string>",
    "amountType" : { CodeableConcept }, // Todo
    "amountText" : "<string>", // Todo
    "source" : [{ Reference(DocumentReference) }] // Todo
  }],
  "target" : [{ // Todo
    "target" : { Identifier }, // Todo
    "type" : { CodeableConcept }, // Todo
    "interaction" : { CodeableConcept }, // Todo
    "organism" : { CodeableConcept }, // Todo
    "organismType" : { CodeableConcept }, // Todo
    "source" : [{ Reference(DocumentReference) }], // Todo
    // amount[x]: Todo. One of these 3:
    "amountQuantity" : { Quantity },
    "amountRange" : { Range },
    "amountString" : "<string>",
    "amountType" : { CodeableConcept } // Todo
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:SubstanceReferenceInformation;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:SubstanceReferenceInformation.comment [ string ]; # 0..1 Todo
  fhir:SubstanceReferenceInformation.gene [ # 0..* Todo
    fhir:SubstanceReferenceInformation.gene.geneSequenceOrigin [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.gene.gene [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.gene.source [ Reference(DocumentReference) ], ... ; # 0..* Todo
  ], ...;
  fhir:SubstanceReferenceInformation.geneElement [ # 0..* Todo
    fhir:SubstanceReferenceInformation.geneElement.type [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.geneElement.element [ Identifier ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.geneElement.source [ Reference(DocumentReference) ], ... ; # 0..* Todo
  ], ...;
  fhir:SubstanceReferenceInformation.classification [ # 0..* Todo
    fhir:SubstanceReferenceInformation.classification.domain [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.classification.classification [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.classification.subtype [ CodeableConcept ], ... ; # 0..* Todo
    fhir:SubstanceReferenceInformation.classification.source [ Reference(DocumentReference) ], ... ; # 0..* Todo
  ], ...;
  fhir:SubstanceReferenceInformation.relationship [ # 0..* Todo
    # SubstanceReferenceInformation.relationship.substance[x] : 0..1 Todo. One of these 2
      fhir:SubstanceReferenceInformation.relationship.substanceReference [ Reference(SubstanceSpecification) ]
      fhir:SubstanceReferenceInformation.relationship.substanceCodeableConcept [ CodeableConcept ]
    fhir:SubstanceReferenceInformation.relationship.relationship [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.relationship.interaction [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.relationship.isDefining [ boolean ]; # 0..1 Todo
    # SubstanceReferenceInformation.relationship.amount[x] : 0..1 Todo. One of these 3
      fhir:SubstanceReferenceInformation.relationship.amountQuantity [ Quantity ]
      fhir:SubstanceReferenceInformation.relationship.amountRange [ Range ]
      fhir:SubstanceReferenceInformation.relationship.amountString [ string ]
    fhir:SubstanceReferenceInformation.relationship.amountType [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.relationship.amountText [ string ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.relationship.source [ Reference(DocumentReference) ], ... ; # 0..* Todo
  ], ...;
  fhir:SubstanceReferenceInformation.target [ # 0..* Todo
    fhir:SubstanceReferenceInformation.target.target [ Identifier ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.target.type [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.target.interaction [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.target.organism [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.target.organismType [ CodeableConcept ]; # 0..1 Todo
    fhir:SubstanceReferenceInformation.target.source [ Reference(DocumentReference) ], ... ; # 0..* Todo
    # SubstanceReferenceInformation.target.amount[x] : 0..1 Todo. One of these 3
      fhir:SubstanceReferenceInformation.target.amountQuantity [ Quantity ]
      fhir:SubstanceReferenceInformation.target.amountRange [ Range ]
      fhir:SubstanceReferenceInformation.target.amountString [ string ]
    fhir:SubstanceReferenceInformation.target.amountType [ CodeableConcept ]; # 0..1 Todo
  ], ...;
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.