Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Extension: ResearchStudyStudyAmendmentDetails

Official URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyStudyAmendmentDetails

Provides detail of a single amendment - repeats within the overal amendment report

Context of Use

    This extension may be used on the following element(s)

Usage info

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... extension 3..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:detail 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "detail"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:rationale 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "section"
..... value[x] 0..1 CodeableConcept Section where the amendment was made
Binding: M11 Section Codes Value Set (required)
... url 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:detail 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "detail"
..... value[x] Σ 0..1 string Statement regarding prior amendments
.... extension:rationale 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "section"
..... value[x] Σ 0..1 CodeableConcept Section where the amendment was made
Binding: M11 Section Codes Value Set (required)
... url Σ 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Provides detail of a single amendment - repeats within the overal amendment report

  • detail: string: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... extension 3..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:detail 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "detail"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:rationale 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "section"
..... value[x] 0..1 CodeableConcept Section where the amendment was made
Binding: M11 Section Codes Value Set (required)
... url 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Extension
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:detail 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "detail"
..... value[x] Σ 0..1 string Statement regarding prior amendments
.... extension:rationale 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:section 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "section"
..... value[x] Σ 0..1 CodeableConcept Section where the amendment was made
Binding: M11 Section Codes Value Set (required)
... url Σ 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Provides detail of a single amendment - repeats within the overal amendment report

  • detail: string: An Extension
  • rationale: string: An Extension
  • section: CodeableConcept: An Extension

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:section.value[x]requiredM11SectionCodesVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs
From this IG

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()