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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the SubstanceSourceMaterial resource.

SubstanceSourceMaterial
Element IdSubstanceSourceMaterial
Definition

Source material shall capture information on the taxonomic and anatomical origins as well as the fraction of a material that can result in or can be modified to form a substance. This set of data elements shall be used to define polymer substances isolated from biological matrices. Taxonomic and anatomical origins shall be described using a controlled vocabulary as required. This information is captured for naturally derived polymers ( . starch) and structurally diverse substances. For Organisms belonging to the Kingdom Plantae the Substance level defines the fresh material of a single species or infraspecies, the Herbal Drug and the Herbal preparation. For Herbal preparations, the fraction information will be captured at the Substance information level and additional information for herbal extracts will be captured at the Specified Substance Group 1 information level. See for further explanation the Substance Class: Structurally Diverse and the herbal annex.

Cardinality0..*
TypeDomainResource
Summarytrue
SubstanceSourceMaterial.sourceMaterialClass
Element IdSubstanceSourceMaterial.sourceMaterialClass
Definition

General high level classification of the source material specific to the origin of the material.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.sourceMaterialType
Element IdSubstanceSourceMaterial.sourceMaterialType
Definition

The type of the source material shall be specified based on a controlled vocabulary. For vaccines, this subclause refers to the class of infectious agent.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.sourceMaterialState
Element IdSubstanceSourceMaterial.sourceMaterialState
Definition

The state of the source material when extracted.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organismId
Element IdSubstanceSourceMaterial.organismId
Definition

The unique identifier associated with the source material parent organism shall be specified.

Cardinality0..1
TypeIdentifier
Summarytrue
SubstanceSourceMaterial.organismName
Element IdSubstanceSourceMaterial.organismName
Definition

The organism accepted Scientific name shall be provided based on the organism taxonomy.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.parentSubstanceId
Element IdSubstanceSourceMaterial.parentSubstanceId
Definition

The parent of the herbal drug Ginkgo biloba, Leaf is the substance ID of the substance (fresh) of Ginkgo biloba L. or Ginkgo biloba L. (Whole plant).

Cardinality0..*
TypeIdentifier
Summarytrue
SubstanceSourceMaterial.parentSubstanceName
Element IdSubstanceSourceMaterial.parentSubstanceName
Definition

The parent substance of the Herbal Drug, or Herbal preparation.

Cardinality0..*
Typestring
Summarytrue
SubstanceSourceMaterial.countryOfOrigin
Element IdSubstanceSourceMaterial.countryOfOrigin
Definition

The country where the plant material is harvested or the countries where the plasma is sourced from as laid down in accordance with the Plasma Master File. For “Plasma-derived substances” the attribute country of origin provides information about the countries used for the manufacturing of the Cryopoor plama or Crioprecipitate.

Cardinality0..*
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.geographicalLocation
Element IdSubstanceSourceMaterial.geographicalLocation
Definition

The place/region where the plant is harvested or the places/regions where the animal source material has its habitat.

Cardinality0..*
Typestring
Summarytrue
SubstanceSourceMaterial.developmentStage
Element IdSubstanceSourceMaterial.developmentStage
Definition

Stage of life for animals, plants, insects and microorganisms. This information shall be provided only when the substance is significantly different in these stages (e.g. foetal bovine serum).

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.fractionDescription
Element IdSubstanceSourceMaterial.fractionDescription
Definition

Many complex materials are fractions of parts of plants, animals, or minerals. Fraction elements are often necessary to define both Substances and Specified Group 1 Substances. For substances derived from Plants, fraction information will be captured at the Substance information level ( . Oils, Juices and Exudates). Additional information for Extracts, such as extraction solvent composition, will be captured at the Specified Substance Group 1 information level. For plasma-derived products fraction information will be captured at the Substance and the Specified Substance Group 1 levels.

Cardinality0..*
Summarytrue
SubstanceSourceMaterial.fractionDescription.fraction
Element IdSubstanceSourceMaterial.fractionDescription.fraction
Definition

This element is capturing information about the fraction of a plant part, or human plasma for fractionation.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.fractionDescription.materialType
Element IdSubstanceSourceMaterial.fractionDescription.materialType
Definition

The specific type of the material constituting the component. For Herbal preparations the particulars of the extracts (liquid/dry) is described in Specified Substance Group 1.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism
Element IdSubstanceSourceMaterial.organism
Definition

This subclause describes the organism which the substance is derived from. For vaccines, the parent organism shall be specified based on these subclause elements. As an example, full taxonomy will be described for the Substance Name: ., Leaf.

Cardinality0..1
Summarytrue
SubstanceSourceMaterial.organism.family
Element IdSubstanceSourceMaterial.organism.family
Definition

The family of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.genus
Element IdSubstanceSourceMaterial.organism.genus
Definition

The genus of an organism shall be specified; refers to the Latin epithet of the genus element of the plant/animal scientific name; it is present in names for genera, species and infraspecies.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.species
Element IdSubstanceSourceMaterial.organism.species
Definition

The species of an organism shall be specified; refers to the Latin epithet of the species of the plant/animal; it is present in names for species and infraspecies.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.intraspecificType
Element IdSubstanceSourceMaterial.organism.intraspecificType
Definition

The Intraspecific type of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.intraspecificDescription
Element IdSubstanceSourceMaterial.organism.intraspecificDescription
Definition

The intraspecific description of an organism shall be specified based on a controlled vocabulary. For Influenza Vaccine, the intraspecific description shall contain the syntax of the antigen in line with the WHO convention.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.author
Element IdSubstanceSourceMaterial.organism.author
Definition

4.9.13.6.1 Author type (Conditional).

Cardinality0..*
Summarytrue
SubstanceSourceMaterial.organism.author.authorType
Element IdSubstanceSourceMaterial.organism.author.authorType
Definition

The type of author of an organism species shall be specified. The parenthetical author of an organism species refers to the first author who published the plant/animal name (of any rank). The primary author of an organism species refers to the first author(s), who validly published the plant/animal name.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.author.authorDescription
Element IdSubstanceSourceMaterial.organism.author.authorDescription
Definition

The author of an organism species shall be specified. The author year of an organism shall also be specified when applicable; refers to the year in which the first author(s) published the infraspecific plant/animal name (of any rank).

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.hybrid
Element IdSubstanceSourceMaterial.organism.hybrid
Definition

4.9.13.8.1 Hybrid species maternal organism ID (Optional).

Cardinality0..1
Summarytrue
SubstanceSourceMaterial.organism.hybrid.maternalOrganismId
Element IdSubstanceSourceMaterial.organism.hybrid.maternalOrganismId
Definition

The identifier of the maternal species constituting the hybrid organism shall be specified based on a controlled vocabulary. For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.hybrid.maternalOrganismName
Element IdSubstanceSourceMaterial.organism.hybrid.maternalOrganismName
Definition

The name of the maternal species constituting the hybrid organism shall be specified. For plants, the parents aren’t always known, and it is unlikely that it will be known which is maternal and which is paternal.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.hybrid.paternalOrganismId
Element IdSubstanceSourceMaterial.organism.hybrid.paternalOrganismId
Definition

The identifier of the paternal species constituting the hybrid organism shall be specified based on a controlled vocabulary.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.hybrid.paternalOrganismName
Element IdSubstanceSourceMaterial.organism.hybrid.paternalOrganismName
Definition

The name of the paternal species constituting the hybrid organism shall be specified.

Cardinality0..1
Typestring
Summarytrue
SubstanceSourceMaterial.organism.hybrid.hybridType
Element IdSubstanceSourceMaterial.organism.hybrid.hybridType
Definition

The hybrid type of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.organismGeneral
Element IdSubstanceSourceMaterial.organism.organismGeneral
Definition

4.9.13.7.1 Kingdom (Conditional).

Cardinality0..1
Summarytrue
SubstanceSourceMaterial.organism.organismGeneral.kingdom
Element IdSubstanceSourceMaterial.organism.organismGeneral.kingdom
Definition

The kingdom of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.organismGeneral.phylum
Element IdSubstanceSourceMaterial.organism.organismGeneral.phylum
Definition

The phylum of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.organismGeneral.class
Element IdSubstanceSourceMaterial.organism.organismGeneral.class
Definition

The class of an organism shall be specified.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.organism.organismGeneral.order
Element IdSubstanceSourceMaterial.organism.organismGeneral.order
Definition

The order of an organism shall be specified,.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.partDescription
Element IdSubstanceSourceMaterial.partDescription
Definition

To do.

Cardinality0..*
Summarytrue
SubstanceSourceMaterial.partDescription.part
Element IdSubstanceSourceMaterial.partDescription.part
Definition

Entity of anatomical origin of source material within an organism.

Cardinality0..1
TypeCodeableConcept
Summarytrue
SubstanceSourceMaterial.partDescription.partLocation
Element IdSubstanceSourceMaterial.partDescription.partLocation
Definition

The detailed anatomic location when the part can be extracted from different anatomical locations of the organism. Multiple alternative locations may apply.

Cardinality0..1
TypeCodeableConcept
Summarytrue