StructureDefinition-ectd-composition-sp4151

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idectd-composition-sp4151
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/ectd-composition-sp4151
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameEctdCompositionSP4151
titleeCTD Specification Composition
date2023-07-17T03:00:13+00:00
descriptionThe fields needed to represent the Quality Specifications to be included under the eCTD 3.2.P.5.1, 3.2.S.4.1, and 3.2.P.4.1 headings.. References Sponsor Organization and Quality Specification.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeComposition
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/Composition
Usages
Name Flags Card. Type Description & Constraints doco
. . Composition Composition
. . . meta
. . . . profile S ..1
. . . identifier S ..1
. . . status Required Pattern: final
. . . type Required Pattern: At least the following
. . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types
. . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: SP4151
. . . . . display 1..1 string Representation defined by the system
Fixed Value: Quality Specification
. . . author S ..1 Reference (Sponsor Organization)
. . . title S
. . . Slices for section S 1 .. 1 Slice: Unordered, Closed by pattern:code
. . . . section:All Slices Content/Rules for all slices
. . . . . title S 1..
. . . . . code S 1.. Binding: eCTD sections Value Set ( required )
. . . . . entry S
. . . . section:DrugProduct S 0..1
. . . . . code Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32P51
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Specification
. . . . . entry 1..1 Reference (Quality Specification)
. . . . section:Api S 0..1
. . . . . code Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S41
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Substance Specification
. . . . . entry 1..1 Reference (Quality Specification)
. . . . section:Excipient S 0..1
. . . . . code Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32P41
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Excipients Specification
. . . . . entry 1..1 Reference (Quality Specification)

doco Documentation for this format

Produced 08 Sep 2023