Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. 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/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Extension:

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 Maturity Level: 2 Computable Name: M11_ProtocolAmendment

Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license.

CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023)

The NCI Thesaurus is released under the CC BY 4.0 license

CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license

For more licensing information and links see: licenses.html

Amendment to a protocol. This is originally from EBM.

Context of Use

    This extension may be used on the following element(s)

    • Element ID: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy

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 Amendment to a protocol - from EBM
... 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 Value of extension
Binding: ICH M11 Amendment Details Statement Value Set Terminology (required)
.... extension:scope S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global, Not Global
Binding: ICH M11 Amendment Scope Value Set Terminology (extensible)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Value of extension
...... 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 Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
.... extension:scopeImpact S 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
.... extension:primaryReason S 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 Terminology (extensible)
.... extension:secondaryReason S 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:summary S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string summary of changes
.... extension:substantialImpactSafety S 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 No Yes Value Set Terminology (required)
.... extension:substantialImpactSafetyComment S 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 No Yes Value Set Terminology (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 S 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Value of extension
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Value of extension
...... valueMarkdown markdown
...... valueString string
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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 Terminology 📦1.0.0-ballot2 This IG
Extension.extension:scope.​value[x] Base extensible ICH M11 Amendment Scope Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:country.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:region.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
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 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..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 "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 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 "previous"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Amendment Details Statement Value Set Terminology (required)
.... extension:scope S 1..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 CodeableConcept Global, Not Global
Binding: ICH M11 Amendment Scope Value Set Terminology (extensible)
.... extension:country 0..* 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 "country"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:region 0..* 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 "region"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:site 0..* 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 "site"
..... value[x] Σ 0..1 Value of extension
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 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 "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 Extension
Slice: Unordered, Open by value:url
..... 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 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 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 "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
.... extension:scopeImpact S 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
.... extension:primaryReason S 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
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:secondaryReason S 0..* 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 "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:summary S 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 "summary"
..... value[x] Σ 0..1 string summary of changes
.... extension:substantialImpactSafety S 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 CodeableConcept Substantial impact on safety
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:substantialImpactSafetyComment S 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 No Yes Value Set Terminology (required)
.... 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:details S 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
.... 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 Value of extension
.... 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 Value of extension
...... valueMarkdown markdown
...... valueString string
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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 Terminology 📦1.0.0-ballot2 This IG
Extension.extension:scope.​value[x] Base extensible ICH M11 Amendment Scope Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:country.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:region.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 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: Amendment to a protocol. This is originally from EBM.

  • 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: 2

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Amendment to a protocol - from EBM
... 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 Value of extension
Binding: ICH M11 Amendment Details Statement Value Set Terminology (required)
.... extension:scope S 1..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "scope"
..... value[x] 0..1 CodeableConcept Global, Not Global
Binding: ICH M11 Amendment Scope Value Set Terminology (extensible)
.... extension:country 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "country"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:region 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "region"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:site 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "site"
..... value[x] 0..1 Value of extension
...... 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 Value of extension
.... extension:signature 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signature"
..... value[x] 0..1 Signature Value of extension
.... extension:signatureUrl 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureUrl"
..... value[x] 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "signatureMethod"
..... value[x] 0..1 string Value of extension
.... extension:scopeImpact S 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
.... extension:primaryReason S 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 Terminology (extensible)
.... extension:secondaryReason S 0..* Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "secondaryReason"
..... value[x] 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:summary S 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "summary"
..... value[x] 0..1 string summary of changes
.... extension:substantialImpactSafety S 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 No Yes Value Set Terminology (required)
.... extension:substantialImpactSafetyComment S 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 No Yes Value Set Terminology (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 S 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
.... extension:rationale 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "rationale"
..... value[x] 0..1 string Value of extension
.... extension:description 0..1 Extension Extension
..... extension 0..0 Extension
..... url 1..1 uri "description"
..... value[x] 0..1 Value of extension
...... valueMarkdown markdown
...... valueString string
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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 Terminology 📦1.0.0-ballot2 This IG
Extension.extension:scope.​value[x] Base extensible ICH M11 Amendment Scope Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:country.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:region.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG

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 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:identifier 1..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 "identifier"
..... value[x] Σ 0..1 Identifier Amendment identifier
.... extension:previous 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 "previous"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Amendment Details Statement Value Set Terminology (required)
.... extension:scope S 1..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 CodeableConcept Global, Not Global
Binding: ICH M11 Amendment Scope Value Set Terminology (extensible)
.... extension:country 0..* 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 "country"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:region 0..* 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 "region"
..... value[x] Σ 0..1 CodeableConcept Value of extension
Binding: ICH M11 Study Amendment Country Value Set (extensible)
.... extension:site 0..* 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 "site"
..... value[x] Σ 0..1 Value of extension
...... valueIdentifier Identifier
...... valueReference Reference(Any)
.... extension:approvalDate 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 "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 Extension
Slice: Unordered, Open by value:url
..... 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 Extension
Slice: Unordered, Open by value:url
..... url Σ 1..1 uri "signatureUrl"
..... value[x] Σ 0..1 Value of extension
...... valueString string
...... valueUrl url
.... extension:signatureMethod 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 "signatureMethod"
..... value[x] Σ 0..1 string Value of extension
.... extension:scopeImpact S 0..3 (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
.... extension:primaryReason S 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
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:secondaryReason S 0..* 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 "secondaryReason"
..... value[x] Σ 0..1 CodeableConcept Reason for amendment, e.g. Manufacturing change
Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
.... extension:summary S 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 "summary"
..... value[x] Σ 0..1 string summary of changes
.... extension:substantialImpactSafety S 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 CodeableConcept Substantial impact on safety
Binding: ICH M11 No Yes Value Set Terminology (required)
.... extension:substantialImpactSafetyComment S 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 CodeableConcept Substantial impact on reliability
Binding: ICH M11 No Yes Value Set Terminology (required)
.... 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:details S 0..* (Complex) Extension
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
.... 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 Value of extension
.... 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 Value of extension
...... valueMarkdown markdown
...... valueString string
... url Σ 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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 Terminology 📦1.0.0-ballot2 This IG
Extension.extension:scope.​value[x] Base extensible ICH M11 Amendment Scope Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:country.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:region.​value[x] Base extensible ICH M11 Study Amendment Country Value Set 📦1.0.0-ballot2 This IG
Extension.extension:primaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:secondaryReason.​value[x] Base extensible ICH M11 Reason for Amendment Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactSafety.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 This IG
Extension.extension:substantialImpactReliability.​value[x] Base required ICH M11 No Yes Value Set Terminology 📦1.0.0-ballot2 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: Amendment to a protocol. This is originally from EBM.

  • 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: 2

 

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