Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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-ballot3 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:

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment Version: 1.0.0-ballot3
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 Differentials, Snapshots, and other representations.

This structure is derived from Extension

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

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

doco Documentation for this format

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()

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

doco Documentation for this format

Snapshot View

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

doco Documentation for this format

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()

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

 

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