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

This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) 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: M11_ProtocolAmendment

Official URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 1 Computable Name: M11_ProtocolAmendment

Amendment to a protocol. This is originally from EBM.

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 Amendment to a protocol - from EBM
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:scope 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "scope"
..... value[x] 0..1 code Global, Not Global
Binding: Study Amendment Scope Value Set (extensible)
.... extension:country 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "country"
..... value[x] 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "region"
..... value[x] 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "site"
..... value[x] 0..1 Identifier Value of extension
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureURL 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signatureURL"
..... value[x] 0..1 string Value of extension
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
.... extension:scopeImpact 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact
.... 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
Binding: Study Amendment Reason Value Set (extensible)
.... extension:secondaryReason 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: Study Amendment Reason Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "summary"
..... value[x] 0..1 string summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 code Substantial impact on safety
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... 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 code Substantial impact on reliability
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... 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:details 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Value of extension
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 string Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Amendment to a protocol - from EBM
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:scope 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 code Global, Not Global
Binding: Study Amendment Scope Value Set (extensible)
.... extension:country 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Identifier Value of extension
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Value of extension
.... extension:signatureURL 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signatureURL"
..... value[x] Σ 0..1 string Value of extension
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
.... extension:scopeImpact 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: Study Amendment Reason Value Set (extensible)
.... extension:secondaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: Study Amendment Reason Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 code Substantial impact on safety
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... 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
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 code Substantial impact on reliability
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
.... extension:rationale 0..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 Value of extension
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 string Value of extension
... url Σ 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Amendment to a protocol. This is originally from EBM.

  • scope: code: An Extension
  • country: code: An Extension
  • region: code: An Extension
  • site: Identifier: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureURL: string: An Extension
  • signatureMethod: string: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: code: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: code: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • rationale: string: An Extension
  • description: string: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Amendment to a protocol - from EBM
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:scope 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "scope"
..... value[x] 0..1 code Global, Not Global
Binding: Study Amendment Scope Value Set (extensible)
.... extension:country 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "country"
..... value[x] 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "region"
..... value[x] 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "site"
..... value[x] 0..1 Identifier Value of extension
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureURL 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signatureURL"
..... value[x] 0..1 string Value of extension
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
.... extension:scopeImpact 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact
.... 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
Binding: Study Amendment Reason Value Set (extensible)
.... extension:secondaryReason 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: Study Amendment Reason Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "summary"
..... value[x] 0..1 string summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 code Substantial impact on safety
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... 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 code Substantial impact on reliability
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... 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:details 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Value of extension
.... extension:description 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "description"
..... value[x] 0..1 string Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Amendment to a protocol - from EBM
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:scope 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "scope"
..... value[x] Σ 0..1 code Global, Not Global
Binding: Study Amendment Scope Value Set (extensible)
.... extension:country 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 code Value of extension
Binding: Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Identifier Value of extension
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Value of extension
.... extension:signature 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Value of extension
.... extension:signatureURL 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signatureURL"
..... value[x] Σ 0..1 string Value of extension
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
.... extension:scopeImpact 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "primaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: Study Amendment Reason Value Set (extensible)
.... extension:secondaryReason 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: Study Amendment Reason Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "substantialImpactSafety"
..... value[x] Σ 0..1 code Substantial impact on safety
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... 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
..... url Σ 1..1 uri "substantialImpactReliability"
..... value[x] Σ 0..1 code Substantial impact on reliability
Binding: CDISC Yes No Unknown Not Applicable Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "substantialImpactReliabilityComment"
..... value[x] Σ 0..1 string Comment on substantial impact on reliability
.... extension:details 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
.... extension:rationale 0..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 Value of extension
.... extension:description 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url Σ 1..1 uri "description"
..... value[x] Σ 0..1 string Value of extension
... url Σ 1..1 uri "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Amendment to a protocol. This is originally from EBM.

  • scope: code: An Extension
  • country: code: An Extension
  • region: code: An Extension
  • site: Identifier: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureURL: string: An Extension
  • signatureMethod: string: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: code: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: code: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • rationale: string: An Extension
  • description: string: An Extension

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:scope.value[x]extensibleM11AmendmentScopeVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs
From this IG
Extension.extension:country.value[x]extensibleM11CountryRegionVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs
From this IG
Extension.extension:region.value[x]extensibleM11CountryRegionVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs
From this IG
Extension.extension:primaryReason.value[x]extensibleM11StudyAmendmentReasonVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs
From this IG
Extension.extension:secondaryReason.value[x]extensibleM11StudyAmendmentReasonVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs
From this IG
Extension.extension:substantialImpactSafety.value[x]requiredCDISCSDTMYesNoUnknownVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs
From this IG
Extension.extension:substantialImpactReliability.value[x]requiredCDISCSDTMYesNoUnknownVS
http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-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()