StructureDefinition-ectd-composition-sp7181

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idectd-composition-sp7181
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/ectd-composition-sp7181
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameEctdCompositionSP7181
titleeCTD Stability Summary and Conclusion Composition
date2023-07-17T03:00:13+00:00
descriptionThe fields needed to represent the Stability Summary and Conclusion to be included in the 3.2.P.8.3 and 3.2.S.7.3 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: SP7181
. . . . . display 1..1 string Representation defined by the system
Fixed Value: Stability Summary and Conclusion
. . . 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 2..2 Reference (Stability Summary | Routine Drug Product)
. . . . 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 2..2 Reference (Stability Summary | Routine Drug Substance)

doco Documentation for this format

Produced 08 Sep 2023