StructureDefinition-pqcmc-component-substance

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-component-substance
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-component-substance
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameComponentSubstance
titleComponent Substance
date2023-07-17T03:00:13+00:00
descriptionAny raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeSubstanceDefinition
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/SubstanceDefinition
Usages
Name Flags Card. Type Description & Constraints doco
. . SubstanceDefinition C SubstanceDefinition cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acid','Polymer','Protein - Other'.
cmc-name-isbt: Name.type ISBT 128 requried for blood products.
cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
. . . meta
. . . . profile S ..1
. . . identifier ..1 optional user designated identifier
. . . classification S 1.. Substance Type
Binding: EVMPD Substance Classification ( required )
. . . grade 1..1 Quality Standard
. . . . coding Binding: Quality Standard Terminology ( required )
. . . manufacturer S ..1 Reference (Manufacturing and/or Test Site Organization)
. . . supplier S ..1 Reference (Supplier Organization)
. . . structure S
. . . . representation 1..
. . . . . representation S
. . . . . format
. . . . . . coding Binding: Chemical Structure Data File Type Terminology ( required )
. . . . . document S Reference (Document Reference Attachment) Substance Structure Graphic
. . . code S
. . . . code
. . . . . Slices for coding Slice: Unordered, Open by pattern:system
. . . . . . coding:unii 0..1 UNII
. . . . . . . system 1.. Required Pattern: https://gsrs.ncats.nih.gov
. . . . . . coding:uniProt 0..1 UniProt ID
. . . . . . . system 1.. Required Pattern: https://www.uniprot.org
. . . Slices for name S C 1 .. Only one name required
Slice: Unordered, Closed by value:type.coding
cmc-name-preferred: Name.preferred: at most one = true
. . . . name:All Slices Content/Rules for all slices
. . . . . preferred S True when the name type is Substance Name
. . . . name:sub S 0..1
. . . . . name S Generic
. . . . . type S 1..
. . . . . . coding S 1..1 Required Pattern: At least the following
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 138
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Generic
. . . . . preferred S
. . . . name:comn S 0..1
. . . . . name S Common
. . . . . type S 1..
. . . . . . coding S 1..1 Required Pattern: At least the following
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 139
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Common
. . . . . preferred S
. . . . name:gsrs S 0..1
. . . . . name S GSRS Preferred
. . . . . type S 1..
. . . . . . coding S 1..1 Required Pattern: At least the following
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 141
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: GSRS Preferred
. . . . . preferred S
. . . . name:isbt S 0..1
. . . . . name S ISBT 128
. . . . . type S 1..
. . . . . . coding S 1..1 Required Pattern: At least the following
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 226
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: ISBT 128
. . . . . preferred S
. . . sourceMaterial S
. . . . type Source Type
. . . . . coding Binding: Source Type Terminology ( required )
. . . . genus S
. . . . . coding .. 0
. . . . . text 1.. Source Organism
. . . . species S Source Organism
. . . . . coding .. 0
. . . . . text 1..
. . . . part S Source Organism Part
. . . . . coding .. 0
. . . . . text 1..
. . . . countryOfOrigin S ..1 Source Organism Country of Origin
. . . . . coding S 1..1 Binding: GENC Country Codes ( required )

doco Documentation for this format

Produced 08 Sep 2023