StructureDefinition-pqcmc-routine-drug-substance

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-routine-drug-substance
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-routine-drug-substance
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameRoutineSubstanceDefinition
titleRoutine Drug Substance
date2023-07-17T03:00:13+00:00
descriptionProvides sufficient information to identify a drug substance. Profile on Drug Substance profile.
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-name-isbt: Name.type ISBT 128 requried for blood products.
. . . identifier S ..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..1 Reference (Manufacturing and/or Test Site Organization)
. . . supplier S ..1 Reference (Supplier Organization)
. . . 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

doco Documentation for this format

Produced 08 Sep 2023