Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Extension: ResearchStudyStudyAmendment

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment Version: 1.0.0-ballot2
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyStudyAmendment
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.97

An amendment to a study protocol.

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 An amendment to a study protocol
... Slices for extension Content/Rules for all slices
.... extension:details 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "details"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 0..1 string Comment on substantial impact on reliability
.... extension:primaryReason 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "primaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"
... value[x] 0..0 Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:details 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "details"
..... value[x] Σ 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafetyComment"
..... value[x] Σ 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
... url Σ 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: An amendment to a study protocol.

  • details: string: An Extension
  • scope: string: An Extension
  • description: string: An Extension
  • rationale: string: An Extension
  • substantialImpactSafety: boolean: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: boolean: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • primaryReason: CodeableConcept: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... Slices for extension Content/Rules for all slices
.... extension:details 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "details"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 0..1 string Comment on substantial impact on reliability
.... extension:primaryReason 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "primaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"
... value[x] 0..0 Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension:details 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "details"
..... value[x] Σ 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "rationale"
..... value[x] Σ 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactSafetyComment"
..... value[x] Σ 0..1 string Comment on substantial impact on safety
.... extension:substantialImpactReliability 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
... url Σ 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: An amendment to a study protocol.

  • details: string: An Extension
  • scope: string: An Extension
  • description: string: An Extension
  • rationale: string: An Extension
  • substantialImpactSafety: boolean: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: boolean: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • primaryReason: CodeableConcept: An Extension

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron

Constraints

Id Grade Path(s) Description Expression
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()