NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceSourceMaterial ΣTUDomainResourceSource 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
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... sourceMaterialClass Σ0..1CodeableConceptGeneral high level classification of the source material specific to the origin of the material
... sourceMaterialType Σ0..1CodeableConceptThe type of the source material shall be specified based on a controlled vocabulary. For vaccines, this subclause refers to the class of infectious agent
... sourceMaterialState Σ0..1CodeableConceptThe state of the source material when extracted
... organismId Σ0..1IdentifierThe unique identifier associated with the source material parent organism shall be specified
... organismName Σ0..1stringThe organism accepted Scientific name shall be provided based on the organism taxonomy
... parentSubstanceId Σ0..*IdentifierThe 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)
... parentSubstanceName Σ0..*stringThe parent substance of the Herbal Drug, or Herbal preparation
... countryOfOrigin Σ0..*CodeableConceptThe 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
... geographicalLocation Σ0..*stringThe place/region where the plant is harvested or the places/regions where the animal source material has its habitat
... developmentStage Σ0..1CodeableConceptStage 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)
... fractionDescription Σ0..*BackboneElementMany 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
.... fraction Σ0..1stringThis element is capturing information about the fraction of a plant part, or human plasma for fractionation
.... materialType Σ0..1CodeableConceptThe 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
... organism Σ0..1BackboneElementThis 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
.... family Σ0..1CodeableConceptThe family of an organism shall be specified
.... genus Σ0..1CodeableConceptThe 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
.... species Σ0..1CodeableConceptThe 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
.... intraspecificType Σ0..1CodeableConceptThe Intraspecific type of an organism shall be specified
.... intraspecificDescription Σ0..1stringThe 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
.... author Σ0..*BackboneElement4.9.13.6.1 Author type (Conditional)
..... authorType Σ0..1CodeableConceptThe 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
..... authorDescription Σ0..1stringThe 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)
.... hybrid Σ0..1BackboneElement4.9.13.8.1 Hybrid species maternal organism ID (Optional)
..... maternalOrganismId Σ0..1stringThe 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
..... maternalOrganismName Σ0..1stringThe 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
..... paternalOrganismId Σ0..1stringThe identifier of the paternal species constituting the hybrid organism shall be specified based on a controlled vocabulary
..... paternalOrganismName Σ0..1stringThe name of the paternal species constituting the hybrid organism shall be specified
..... hybridType Σ0..1CodeableConceptThe hybrid type of an organism shall be specified
.... organismGeneral Σ0..1BackboneElement4.9.13.7.1 Kingdom (Conditional)
..... kingdom Σ0..1CodeableConceptThe kingdom of an organism shall be specified
..... phylum Σ0..1CodeableConceptThe phylum of an organism shall be specified
..... class Σ0..1CodeableConceptThe class of an organism shall be specified
..... order Σ0..1CodeableConceptThe order of an organism shall be specified,
... partDescription Σ0..*BackboneElementTo do
.... part Σ0..1CodeableConceptEntity of anatomical origin of source material within an organism
.... partLocation Σ0..1CodeableConceptThe detailed anatomic location when the part can be extracted from different anatomical locations of the organism. Multiple alternative locations may apply

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