StructureDefinition-cmc-ectd-document-sp4151

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idcmc-ectd-document-sp4151
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/cmc-ectd-document-sp4151
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameCMCeCTDDocumentSP4151
titleCMC eCTD SP4151 Document
date2023-07-17T03:00:13+00:00
descriptionDefinition for a document bundle with the CMC eCTD SP4151 profiles.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeBundle
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/Bundle
Usages(none)
Name Flags Card. Type Description & Constraints doco
. . Bundle C Bundle CMC eCTD SP4151 Bundle
cmc-first-resource: A document must have a Composition as the first resource
cmc-identifer: A document must have an identifier with a system and a value
. . . meta
. . . . versionId S 1..
. . . identifier S 1..
. . . type S document
Fixed Value: document
. . . timestamp S 1..
. . . Slices for entry S 3 .. Slice: Unordered, Open by profile:resource
. . . . entry:Composition 1..1
. . . . . fullUrl 1..
. . . . . resource 1.. Composition
. . . . entry:PlanDefinition 1..1
. . . . . fullUrl 1..
. . . . . resource 1.. PlanDefinition
. . . . entry:MedicinalProductDefinition 0..1
. . . . . fullUrl 1..
. . . . . resource 1.. MedicinalProductDefinition
. . . . entry:SubstanceDefinition 0..1
. . . . . fullUrl 1..
. . . . . resource 1.. SubstanceDefinition
. . . . entry:Excipient 0..1
. . . . . fullUrl 1..
. . . . . resource 1.. SubstanceDefinition
. . . . entry:Organization 1..1
. . . . . fullUrl 1..
. . . . . resource 1.. Organization
. . . . entry:OrganizationMfg 0..*
. . . . . fullUrl 1..
. . . . . resource 1.. Organization

doco Documentation for this format

Produced 08 Sep 2023