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-m11-protocol-amendment Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ResearchStudyM11ProtocolAmendment
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.163

An amendment to a study protocol matching M11 template.

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.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:identifier 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "identifier"
..... value[x] 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "previous"
..... value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Signature Method
.... extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact
.... 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
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... 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:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Description
...... valueMarkdown markdown
...... valueString string
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "previous"
..... value[x] Σ 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... id 0..1 string 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 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Signature Method
.... extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 string 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
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 string 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 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 string 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 string 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 string 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:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... id 0..1 string 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:description 0..1 Extension Extension
..... id 0..1 string 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 Description
...... valueMarkdown markdown
...... valueString string
... url Σ 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG

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()

Summary

Complex Extension: An amendment to a study protocol matching M11 template.

  • identifier: Identifier: An Extension
  • previous: CodeableConcept: An Extension
  • scope: CodeableConcept: An Extension
  • country: CodeableConcept: An Extension
  • region: CodeableConcept: An Extension
  • site: Identifier, Reference: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: CodeableConcept: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: CodeableConcept: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • rationale: string: An Extension
  • description: markdown, string: An Extension

Maturity: 1

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:identifier 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "identifier"
..... value[x] 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "previous"
..... value[x] 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "approvalDate"
..... value[x] 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Signature Method
.... extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact
.... 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
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "substantialImpactSafety"
..... value[x] 0..1 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... 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:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Rationale
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Description
...... valueMarkdown markdown
...... valueString string
... url 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension An amendment to a study protocol
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "previous"
..... value[x] Σ 0..1 CodeableConcept Statement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
.... extension:scope 1..1 Extension Extension
..... id 0..1 string 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 CodeableConcept Global or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
.... extension:country 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "country"
..... value[x] Σ 0..1 CodeableConcept Country
.... extension:region 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "region"
..... value[x] Σ 0..1 CodeableConcept Region
.... extension:site 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "site"
..... value[x] Σ 0..1 Site
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "approvalDate"
..... value[x] Σ 0..1 date Approval date
.... extension:signature 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signature"
..... value[x] Σ 0..1 Signature Signature
.... extension:signatureUrl 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Signature URL
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureMethod"
..... value[x] Σ 0..1 string Signature Method
.... extension:scopeImpact 0..3 (Complex) Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact
.... extension:primaryReason 0..1 Extension Extension
..... id 0..1 string 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
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:secondaryReason 0..* Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
.... extension:summary 0..1 Extension Extension
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "summary"
..... value[x] Σ 0..1 string Summary of changes
.... extension:substantialImpactSafety 0..1 Extension Extension
..... id 0..1 string 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 CodeableConcept Substantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactSafetyComment 0..1 Extension Extension
..... id 0..1 string 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 string 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
.... extension:substantialImpactReliabilityComment 0..1 Extension Extension
..... id 0..1 string 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:details 0..* (Complex) Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... id 0..1 string 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:description 0..1 Extension Extension
..... id 0..1 string 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 Description
...... valueMarkdown markdown
...... valueString string
... url Σ 1..1 uri "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:previous.​value[x] Base required ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG
Extension.extension:scope.​value[x] Base required ICH M11 Amendment Scope Value Set 📦1.0.0-ballot3 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 Yes No Value Set 📦1.0.0-ballot3 This IG

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()

Summary

Complex Extension: An amendment to a study protocol matching M11 template.

  • identifier: Identifier: An Extension
  • previous: CodeableConcept: An Extension
  • scope: CodeableConcept: An Extension
  • country: CodeableConcept: An Extension
  • region: CodeableConcept: An Extension
  • site: Identifier, Reference: An Extension
  • approvalDate: date: An Extension
  • signature: Signature: An Extension
  • signatureUrl: string, url: An Extension
  • signatureMethod: string: An Extension
  • primaryReason: CodeableConcept: An Extension
  • secondaryReason: CodeableConcept: An Extension
  • summary: string: An Extension
  • substantialImpactSafety: CodeableConcept: An Extension
  • substantialImpactSafetyComment: string: An Extension
  • substantialImpactReliability: CodeableConcept: An Extension
  • substantialImpactReliabilityComment: string: An Extension
  • rationale: string: An Extension
  • description: markdown, string: An Extension

Maturity: 1

 

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