StructureDefinition-ectd-composition-sp7383

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idectd-composition-sp7383
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/ectd-composition-sp7383
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameEctdCompositionSP7383
titleeCTD Stability Data Composition
date2023-07-17T03:00:13+00:00
descriptionThe fields needed to represent the Stability Data to be included under the 3.2.P.8.3 , 3.2.S.7.3 and 3.2.P.4.5 eCTD headings. References Sponsor Organization and Stability Study.
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: SP7383
. . . . . display 1..1 string Representation defined by the system
Fixed Value: Stability Data
. . . author S ..1 Reference (Sponsor Organization)
. . . Slices for section S 1 .. Slice: Unordered, Closed by pattern:code
. . . . section:All Slices Content/Rules for all slices
. . . . . entry S
. . . . section:DrugProduct S 0..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: 32P83
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Stability Data
. . . . . entry 1..1 Reference (Stability Study)
. . . . section:Api S 0..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: 32S73
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Substance Stability Data
. . . . . entry 1..1 Reference (Stability Study)

doco Documentation for this format

Produced 08 Sep 2023