StructureDefinition-ectd-composition-32s30

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idectd-composition-32s30
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/ectd-composition-32s30
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameEctdComposition32S30
titleeCTD Substance Characterization
date2023-07-17T03:00:13+00:00
descriptionThe fields needed to represent the Substance Structure and Impurities to be included under the 3.2.S.3.0 heading of the eCTD. References Sponsor Organization, Drug Substance Structure, and Drug Substance Impurities
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: 32S30
. . . . . display 1..1 string Representation defined by the system
Fixed Value: Substance Characterization
. . . author S ..1 Reference (Sponsor Organization)
. . . title S
. . . Slices for section S 1 .. Slice: Unordered, Open by value:code
. . . . section:All Slices Content/Rules for all slices
. . . . . entry S
. . . . section:Structure S 1..1
. . . . . title S 1..
. . . . . code 1.. 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: 32S31
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
. . . . . entry 1..1 Reference (Drug Substance)
. . . . section:Impurities S 0..*

doco Documentation for this format

Produced 08 Sep 2023