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

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, 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: Draft 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

Usage:

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 & Constraintsdoco
.. 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
..... url 1..1 uri "details"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "scope"
..... value[x] 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0
..... 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
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0
..... 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
..... 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
..... url 1..1 uri "details"
..... value[x] 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
..... url 1..1 uri "scope"
..... value[x] 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
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 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
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 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
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 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
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 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
..... 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"

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 & Constraintsdoco
.. 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
..... url 1..1 uri "details"
..... value[x] 0..1 string Statement regarding prior amendments
.... extension:scope 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "scope"
..... value[x] 0..1 string Global, Coutnry, Region, or Site
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 boolean Substantial impact on safety
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... extension 0..0
..... 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
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 0..1 boolean Substantial impact on reliability
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... extension 0..0
..... 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
..... 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

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
..... url 1..1 uri "details"
..... value[x] 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
..... url 1..1 uri "scope"
..... value[x] 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
..... url 1..1 uri "description"
..... value[x] 0..1 string Description
.... extension:rationale 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 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
..... url 1..1 uri "substantialImpactSafetyComment"
..... value[x] 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
..... url 1..1 uri "substantialImpactReliability"
..... value[x] 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
..... url 1..1 uri "substantialImpactReliabilityComment"
..... value[x] 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
..... 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"

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

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()